Certificate
Diploma
MSc
Module 1
Pharmaceutical Law & Administration
✔
✔
✔
Module 2
Medicinal Chemistry & Therapeutics
*
✔
✔
Module 3a
Pharmaceutical Formulation & Processing, Part 1
*
✔
✔
Module 3b
Pharmaceutical Formulation & Processing, Part 2
*
✔
✔
Module 4
Pharmaceutical Microbiology
*
✔
✔
Module 5
Active Pharmaceutical Ingredients
*
✔
✔
Module 6
Mathematics & Statistics
*
✔
✔
Module 7
Analysis & Testing
*
✔
✔
Module 8
Pharmaceutical Packaging
*
✔
✔
Module 9
Quality Management Systems
✔
✔
✔
Module 10
Practical Module
*
✔
✔
Module 11
Investigational Medicinal Products
*
✔
✔
Module 12
The Role & Professional Duties of the QP
✔
✔
✔
✔
✔
✔
Paper I
✔
✔
✔
Paper II
NA
✔
✔
MSc Project
NA
NA
✔
Approved
training
Ap
pr Now
ov
ed RSC
Tra
ini
ng
Three compulsory foundation modules (✔) plus three of choice (*) for Certificate
Module assessments (for modules taken)
Composite course written exam
What’s Included in the Module
Fees
>12 customized reference books covering all course
notes, with no further background reading required
>Exams for benchmarking or postgraduate study
Additional Benefits
For delegates attending all 12 QP modules, a 50% reduction in
course fees for recommended additional courses including…
>GMP for Biological and Biotechnology Products
>Visits
>Effective Pharmaceutical Audits and Self-Inspections
(An IRCA Certified Pharmaceutical QMS Auditor/Lead
Auditor Course)
>Daytime conference facilities
>Risk-Based Decision Making for Quality Professionals and QPs
>Lunch and refreshments
>Risk-Based Decision Making in Sterile Products Manufacture
>Course dinner
>For delegates paying for all modules in advance, a discount of 15%
off the total cost will be applied (candidates paying in advance will
be excluded from the multiple delegate discounts available)
>Certificates of attendance
Special bed and breakfast rates are available for
NSF delegates (not included in course fees)
Discounts Available
>20% for second delegate attending same module
from same company
>50% for third and subsequent delegates attending
same module from same company
>50% for NHS and Regulatory Authorities
>Discounts also available, at the discretion of the
course leaders, for self-funding individuals and for
certain charities
>Other rewards and discounts are available. Please talk to Stella
Pearson-Smith, QP Administrator, for current offers.
How to Reserve a Place
To provisionally reserve a place on the series or any individual
modules, or for further information, please contact our QP Course
Administrator at QPpharma@nsf.org.
Online Reservation
Provisional and firm bookings can be made via our
website www.nsf.org/info/pharma-training
The information contained in this brochure is correct at the time of printing and is published in good faith. We reserve the right to make any changes which may become necessary.
emailQPpharma@nsf.org
tel
+44 (0) 1751 432 999
fax
+44 (0) 1751 432 450
post The Georgian House,
22-24 West End, Kirkbymoorside,
York, UK, YO62 6AF
www.nsf.org
LPH-372-1215
Qualified Person and
Continuing Professional
Development Training
With Opportunity for Postgraduate Qualification
www.nsfpharmabiotech.org
The right people. The right solution. The first time.™
For further information on module content,
to arrange a free gap analysis or to talk to
someone about the process and eligibility,
please contact Stella Pearson-Smith, QP
Administrator, at StellaPearsonSmith@nsf.org
or call +44 (0) 1751 432 999
Add your name to the NSF roll of honour
– all these people have trained with us
Why
Choose
We have been running Qualified Person (QP) training courses since 1990 and they are generally
considered to be the best available – our QPs are very highly regarded within the industry
and their status is recognised by many other countries including Austria, Belgium, Denmark,
Hungary, Ireland, Jordan, Malta, The Netherlands, Norway and Switzerland.
Did you know? We have an exceptionally high first-time pass rate for our trainee QPs who have been successful at QP interview.
For those who are not successful we will continue to offer free ongoing support including free repeat courses as required and extra
Viva practices. Along with support from their sponsors, this will help guarantee that all our trainees achieve QP eligibility. The course provides practical, face-to-face tuition in sufficient depth to prepare you fully for the challenges ahead. The plain fact is
that you are more likely to become a QP with us than with any other training provider.
The Aspiring QP and
Technical Professional
2
>12 modules over 21 months
>More than meets the requirements of the UK QP Study Guide
and 2001/82 EC, 2001/83 EC
>Essential CPD for all, not only QPs
What We Offer Core QPs
(delegates taking four or more modules)
>A personal assigned tutor available throughout
the program
>Individual training advice
>Support for delegates and sponsors
>New technical, essential skills training
What We Offer – The Course
♦
Presentation techniques
♦
Coaching and mentoring
♦
Assertiveness
♦
Leadership
♦
♦
Decision making
>Supported by lecturers from one of the country’s top Schools
of Pharmacy
apid learning
R
techniques
♦
And others
♦
> Uniquely, you have the time required to learn and thoroughly
understand:
>Viva prep sessions including scenario tutorials and
decision making
>Unequalled training for highly experienced industrial experts and
experienced QPs
♦
The knowledge
♦
The skills
♦
The role
>Highly interactive, face-to-face education
>Training to do the job, not just pass an exam
>Flexible courses start and stop to suit you
>Postgraduate qualifications as necessary from Postgraduate
Certificate to MSc
>Most successful QP training course available
What We Offer You
>Help in formulating your own training and experience plan
>Use of the unique gap analysis tool
>Greatest opportunity for success
> Unequalled networking opportunity
> Complete, detailed training and reference materials
Conflict management
>Review of application form
>Revision interview
>Sponsor/tutor meetings on modules
>Alumni organization of experienced fellow QPs sharing
the same training
>CPD
>Ongoing access to NSF and its consultants
Scan the QR
code to find
out more about
QP training
with NSF
Health Sciences.
Approved
training
Reserve your place: web: www.nsf.org/info/pharma-training
Nigel Adams • Gareth Adlam • Stuart Allen • Paul Anderson • Richard Angwin • Kate Barker • Lynda
Baker • Suzanne Ball • Justin Barry • Cathy Bateman • Daniel Bell • David Belshaw • Christine Bennett •
Neil Bennett • Dale Billingsley • Sonia Bradford • Lynn Bryan • Philip Butson • Samantha Clack • Robert
Clarke • Neil Connor • Peter Cormack • Roy Cowell • Bruce Cuthbertson • Kris Davé • Faith Daykin •
Martin Dearden • Peter Deegan • Karam Dhaliwal • Robert Dilks • Elaine Dymond • David Earl • Sam
Elcomb • Grant Elliott • Clare Embley • Elizabeth Evans • Marcus Evans • Karl Fry • Richard Funnell
• Mayuur Gohill • Amanda Hall • Johan Havinga • Paul Henly • Nick Hill • Nigel Holcombe • Judith
Hoodless • Mark Hughes • Sandra Illsley • Ronald Imhoff • Mike Irving • Ian Jackson • Sukhbinder
Jaiswal • Hazel James • Phil Jenkinson • John Johnson • Adam Jones • Jantine Jonkman • Julian Kay
• Tony Kem • Mark Kind • Boudy König • Sheila Lachut • Bob Lambert • Trevor Lees • Fraser Leslie •
Brian Lewis • Debbie Lloyd • Alison Lockett • Tony Loeffen • Veronika Lothian • Martin Lush • Karen
Lynch • Fiona MacIntyre • Tony Mayhall • Grame McBurney • Robert McConnell • Thomas McHale •
Fiona McLaren • Wallace McRobert • Kim Morwood • Stephen Moss • Derek Murphy • Shirley Mutch
• Anneke Nederbragt • Deborah Nugent • Russell Nugent • Paul O’Connor • Brendan O’Dorman •
Tony Osbourne • David Palmer • Philip Parry • Zen Pawlack • Andrew Pentelow • Anna Pickering • Ian
Pounder • Martnie Powell • Nick Precious • David Preston • David Price • Neil Raw • Annie Rietveld •
Mike Roberts • David Robinson • Richard Rogers • David Ross • Michael Rowe • Monika Sauter • John
Seager • Jane Shaw • Stephen Simpson • Cate Sims • Richard Smalley • Robert Smith • Scott Smith •
Andrew Spence • Martin Spencer • Peter Stancliffe • Wendy Steele • Paul Stockbridge • Paul Thomas
• Emma Thomason • Bill Thorne • Mandy Turgoose • Pamela Turner • Lena Vägberg • Piet Van Rens
• Maria Vincent • Indira Walker • Neil Wayman • Gordon Whittle • Richard Wilford • Richard Wilkins •
Sam Williamson • Kevin Wilson • Christopher Woodage • Paul Wright • Jane Williams • Gareth Naylor •
Mark Girdwood • David Ling • Alan Mayo • Mukesh Patel • Rachel Mizzi • Nick Branch • Mark Sephton
• Leonor Arrebola • Hernal Patel • Emily Rumsey • Jennifer Watson • Catherine Kay • James Muller
• Daniel Pilkington • Peter Gannon • Joanne Lewis • Matthew Jaynes • Chris Miller • Gillian Morris •
Colin Newbould • John O’Neill • Graeme Perkins • Angela Hoskins • Jenni Newcombe • Vicky Baulch
• Jane Colman • Mark Dignum • Bruce Vernon • Trevor Clarke • Derrick Jones • Simon Tanner • Tim
Dickinson • Treena Edwards • Meriam Lindsay • Mark Hinton • Helen Brannan • Ruth Buchanan • Tony
Pinney • Dawn Harrison • Kate Krachai • Breda Quinn • Ronnie O’Connell • Stephen Davenport • Dru
Homer • Neil Smith • Ed Teece • Claire Pierce • Barbara O’Dwyer • Cecile Begat • Jordan Costello •
Trevor Watson • Robert Clayton • John Tognarelli • Philip Millward • Justin Ahern • Colin Chambers •
Kathryn Rooney • Amanda Race • Rachel Evans • Nigel Morton • Richard Brown • Shawn Murtough
• Ian Birch • Claire Montgomery • Giby George • Jonathan Dormer • David Jamieson • Stefan
Verstegen • Peter Kendrick • Chris Forrest • James Culyer • John Horry • Chris Hinds • Maria Adesida
• Jack Beattie • Donna McKenna • Richard Brown • Stephen Clarke • Philip Davies • Nigel Chesterton
• Jonathan Bradshaw • Sarah Gardiner • Shaun Barford • David Thomson • Azhar Salahudeen •
Claire Trumper • Jason Morris • Phil Cryan • Eurwyn Roberts • Stephan Croft • Leen van de Water •
Jacqueline Barry • David Franks • Hazel Pitt • Linden Stead • Adam McLennan • Laura Matthys • Jasbir
Rattu • Attia Hasnain • Stephen Swan • Rachael Hill • Set Yong • Pauline Johnstone • Lee Heading •
Abdul Ghafoor • Maxine Shaw • Lana Morrison • Peter Mollison • Akbar Kulasi • Kate Smith • Philip
Rose • Paul Gomm • Helen O’Shea • Richard Gore • David Cross • Arthur Stevenson • Adam Elliott •
Clare Myatt • Robert Scott • Lynsey Niblett • Anne Moore • Caroline Gibbs • Tony James • Steve Evans
• Julia Hocking • Jill O’Mullane • David Harvey
NSF Ongoing Support/Advice
NSF
Training
NSF Advice
UK Procedure to Become a “Qualified Person”
Under the Permanent Provisions of European
Council Directives 2001/82/EC and 2001/83/EC
RELEVANT FIRST DEGREE OR EQUIVALENT QUALIFICATION in
BIOLOGY, CHEMISTRY or PHARMACY
JOINS PROFESSIONAL BODY
(“Member” status minimum)
UNDERTAKES:
(1) Appropriate practical experience and
(2) Supplementary educational study through NSF QP training
APPLIES to PROFESSIONAL BODY FOR:
(1) Suitability by assessment
(2) Recognition of eligibility to be entered into the joint register
NOMINATED as “QP” by HOLDER of
MANUFACTURING AUTHORIZATION
LICENSING AUTHORITY of MEDICINES AND HEALTHCARE PRODUCTS
REGULATORY AGENCY, DoH, ACCEPT NOMINATION
INDIVIDUAL MAY ACT as a QUALIFIED
PERSON FOR a LICENCE HOLDER
QPs in Europe
Increasingly the NSF QP course is attended by non-UK European
delegates. National requirements for QP training and education may
differ and many European individuals attend for the following reasons:
Contact us for further information:
>To access the best training for quality leaders in the
pharmaceutical industry
Mike Halliday,
Vice President, NSF Health Sciences, Pharma Biotech
Consulting (mikehalliday@nsf.org)
or
Stella Pearson-Smith,
QP Administrator (StellaPearsonSmith@nsf.org).
telephone: +44 (0) 1751 432999
email: QPpharma@nsf.org
>To gain an MSc to meet educational requirements
>To obtain CPD to meet knowledge requirements
3
Technical Syllabus
Our syllabus more than meets the requirements
of the QP study guide. Examples of topics include:
MODULE 4
MODULE 1
> Biology and biochemistry of microorganisms
>Pyrogens
> Antimicrobial compounds
> Sterilization and disinfection
>Microbiological aspects of quality water
systems
>Microbiological aspects of sterile
pharmaceuticals manufacture
PHARMACEUTICAL LAW &
ADMINISTRATION
>
>
>
>
>
>
European medicines legislation
United Kingdom medicines legislation
Other relevant legislation
Licensing and inspection
Standards and guidelines
Qualified Person administration issues
MODULE 2
4
MEDICINAL CHEMISTRY &
THERAPEUTICS
> Functions of the body
> Major disease states
>Pharmacology
> Implications of clinical knowledge for the QP
MODULE 3
PHARMACEUTICAL FORMULATION &
PROCESSING
>Dosage forms, routes of administration,
biopharmaceutics
> Formulation aspects
> Manufacturing aspects and CCP
PHARMACEUTICAL MICROBIOLOGY
MODULE 5
ACTIVE PHARMACEUTICAL
INGREDIENTS
> Regulatory aspects
>Manufacturing processes and their influence
on quality
> Supplier quality assurance
>Analysis
> Bulk biologicals and biotech products
MODULE 6
MATHEMATICS & STATISTICS
>Introduction
> Use and application
> Use of computers and software
> Future trends
MODULE 7
ANALYSIS & TESTING
> Philosophy and principles of analysis; GCLP
>Stability
>Physico-chemical properties of materials/
principal methods of analysis
>Method validation
> Industrial practice and standards
Reserve your place: web: www.nsf.org/info/pharma-training
Approved
training
MODULE 8
PHARMACEUTICAL PACKAGING
>
>
>
>
>
>
Materials and components
Supplier auditing and component testing
The printing process
The packing process – ideal facility design
The route to the patient
QP decision making
MODULE 9
QUALITY MANAGEMENT SYSTEMS
> Principles and philosophy
> Designing an effective QMS
> Interpersonal skills
>QMS and supply chain control
> QMS and continuous improvement
MODULE 10
PRACTICAL MODULE
This module provides an opportunity to
manufacture and test a range of dosage forms.
Each delegate will be able to obtain experience in
the manufacture of a variety of dosage forms with
consideration of:
MODULE 11
INVESTIGATIONAL MEDICINAL
PRODUCTS
>The regulatory framework for clinical trials,
including latest changes
> Clinical trial design
> Levels of GMP and validation required
> IMP
MODULE 12
THE ROLE & PROFESSIONAL DUTIES OF
THE QUALIFIED PERSON
>
>
>
>
• Documentation required
• Process parameters
• Critical Control Points
• In-process controls applicable
• Concerns for the QP
Duties and responsibilities of the QP
Role of the QP
Future trends
Interpersonal skills to do the job
Join our Alumni Family
2016 marks the tenth annual NSF
QP Alumni meeting. This ongoing
support network for the NSF QPs
provides invaluable CPD for the
busy QP and a lifelong support
after the course is completed.
• End product testing
This includes oral solid dose, sterile, biotech
and analytical hands-on experience. Additional
experience is required for the UK QP
application process.
telephone: +44 (0) 1751 432999
email: QPpharma@nsf.org
5
Approved
training
Postgraduate Certificate, Diploma or MSc
in Pharmaceutical Quality and Good
Manufacturing Practice
While each module is a stand-alone course, increasingly
delegates are taking all modules with NSF and aiming for
postgraduate qualifications.
awarded the University Diploma in Pharmaceutical Quality and
Good Manufacturing Practice. The duration of the study parallels
the QP modules, i.e. 21 months.
Background
MSc
Recognition in the industry and by your peers is always an
important incentive to both the individual and the company.
NSF Pharma Biotech offers, for those taking Qualified Person
(QP) training, an opportunity to gain postgraduate qualifications,
depending on how much time you can afford to put in.
Holders of the Diploma who have attained a suitably
satisfactory result may proceed to the University of Strathclyde
MSc in Pharmaceutical Quality and Good Manufacturing
Practice by undertaking a supervised, industrially relevant
project on a subject approved by the Course Director.
Candidates will be required to satisfy the Board of Examiners
in a presentation of their project dissertation and in an oral
examination. Projects shall normally be submitted within six
months of completing the Diploma course.
The Benefits of Attending all Modules
6
>Linked consistent education with practice in QP decision
making skills throughout
>Linked training to do the QP job, not just pass a Viva
>Reinforcement of key messages
>Access to discounts for MSc
>Benchmarking exams to confirm progress
>Access to discounted additional courses essential to the QP
>Enhanced networking
>Access to CPD for the delegate and for the company
>Sponsor support and sponsor/NSF tutor meetings
>Plus the many other benefits of being a core delegate, as
detailed on page 2
Certificate
Exemptions and Rewards
>Diploma/MSc candidates can apply for one exemption for a
module covering a topic of existing expertise. However, for
those taking all 12 modules, NSF Pharma Biotech will pay
£1500 towards the University of Strathclyde Diploma/MSc fees
>Candidates who achieve an MSc will be invited to attend
NSF Pharma Biotech’s annual one-day QP Continuing
Professional Development course as our guest for life*
>Delegates who gain UK QP status, or an MSc or Diploma will
be entitled to apply for membership of the Chartered Quality
Institute (CQI) to gain MCQI status
For the quality professional who is looking to gain a further
qualification or just recognition in their profession. You will need
to complete three NSF Pharma Biotech foundation modules and
three modules of your own choice, and perform satisfactorily
in the assessments for each, to be eligible to apply for the
Postgraduate Certificate with the University of Strathclyde.
>Registration with the University of Strathclyde confers
student status and permits use of all student facilities
Diploma
Fees
Delegates registered for the Diploma qualification who perform
satisfactorily in the module assessment procedures may then
sit the course Diploma examinations. If successful, they will be
For further information regarding the University fees for the
Postgraduate Certificate, Diploma, MSc and any other details
please contact Dr Chris Prior at c.b.prior@strath.ac.uk
These postgraduate qualifications are awarded by the
University of Strathclyde, which is regularly in the top ranks of
Schools of Pharmacy in the UK.
*up to a maximum of ten free places per course
Reserve your place today
web: www.nsf.org/info/pharma-training
telephone: +44 (0) 1751 432999
email: QPpharma@nsf.org
Certificate
Diploma
MSc
Module 1
Pharmaceutical Law & Administration
✔
✔
✔
Module 2
Medicinal Chemistry & Therapeutics
*
✔
✔
Module 3a
Pharmaceutical Formulation & Processing, Part 1
*
✔
✔
Module 3b
Pharmaceutical Formulation & Processing, Part 2
*
✔
✔
Module 4
Pharmaceutical Microbiology
*
✔
✔
Module 5
Active Pharmaceutical Ingredients
*
✔
✔
Module 6
Mathematics & Statistics
*
✔
✔
Module 7
Analysis & Testing
*
✔
✔
Module 8
Pharmaceutical Packaging
*
✔
✔
Module 9
Quality Management Systems
✔
✔
✔
Module 10
Practical Module
*
✔
✔
Module 11
Investigational Medicinal Products
*
✔
✔
Module 12
The Role & Professional Duties of the QP
✔
✔
✔
✔
✔
✔
Paper I
✔
✔
✔
Paper II
NA
✔
✔
MSc Project
NA
NA
✔
Approved
training
Ap
pr Now
ov
ed RSC
Tra
ini
ng
Three compulsory foundation modules (✔) plus three of choice (*) for Certificate
Module assessments (for modules taken)
Composite course written exam
What’s Included in the Module
Fees
>12 customized reference books covering all course
notes, with no further background reading required
>Exams for benchmarking or postgraduate study
Additional Benefits
For delegates attending all 12 QP modules, a 50% reduction in
course fees for recommended additional courses including…
>GMP for Biological and Biotechnology Products
>Visits
>Effective Pharmaceutical Audits and Self-Inspections
(An IRCA Certified Pharmaceutical QMS Auditor/Lead
Auditor Course)
>Daytime conference facilities
>Risk-Based Decision Making for Quality Professionals and QPs
>Lunch and refreshments
>Risk-Based Decision Making in Sterile Products Manufacture
>Course dinner
>For delegates paying for all modules in advance, a discount of 15%
off the total cost will be applied (candidates paying in advance will
be excluded from the multiple delegate discounts available)
>Certificates of attendance
Special bed and breakfast rates are available for
NSF delegates (not included in course fees)
Discounts Available
>20% for second delegate attending same module
from same company
>50% for third and subsequent delegates attending
same module from same company
>50% for NHS and Regulatory Authorities
>Discounts also available, at the discretion of the
course leaders, for self-funding individuals and for
certain charities
>Other rewards and discounts are available. Please talk to Stella
Pearson-Smith, QP Administrator, for current offers.
How to Reserve a Place
To provisionally reserve a place on the series or any individual
modules, or for further information, please contact our QP Course
Administrator at QPpharma@nsf.org.
Online Reservation
Provisional and firm bookings can be made via our
website www.nsf.org/info/pharma-training
The information contained in this brochure is correct at the time of printing and is published in good faith. We reserve the right to make any changes which may become necessary.
emailQPpharma@nsf.org
tel
+44 (0) 1751 432 999
fax
+44 (0) 1751 432 450
post The Georgian House,
22-24 West End, Kirkbymoorside,
York, UK, YO62 6AF
www.nsf.org
LPH-372-1215
Qualified Person and
Continuing Professional
Development Training
With Opportunity for Postgraduate Qualification
www.nsfpharmabiotech.org
The right people. The right solution. The first time.™
For further information on module content,
to arrange a free gap analysis or to talk to
someone about the process and eligibility,
please contact Stella Pearson-Smith, QP
Administrator, at StellaPearsonSmith@nsf.org
or call +44 (0) 1751 432 999
> MODULE 2
MEDICINAL CHEMISTRY
& THERAPEUTICS
Subject Sessions
Introduction to Physiological Processes
Transmission Across a Synapse: Signal
Transmission in the Nervous System
Module Content
Autonomic Nervous System
Fundamentals of Solid Dose
Formulations
Good Gowning Practice
Sterility Testing
Aseptic Filling of Vials and Ampoules
Microbiological Validation of Clean Rooms
Teamwork: Powder Flow Properties
An Overview of Lyophilization
Capsules
Visual Inspection of Parenteral Products
Microbiological Environmental
Monitoring Methods
GMP Issues for Solid Dose
Manufacture
Process Simulation Trials and Their
Insight into Sterility Assurance
Teamwork: Facility Design
Case Study: Process Simulation Failures
Blending and Granulation
The Pulmonary Route of Administration
Teamwork: Blending and Granulation
Metered Dose Inhalers
Tablet Compression
An Overview of Parametric Release
Teamwork: Compression
Microbiological Risk Assessment
QP Scenarios – Root Cause Analysis
The NSF Health Sciences QP course is designed to meet the requirements
of the UK Study Guide.
Introduction to Drug Action
Each module is designed as a stand-alone course, so although the modules
are numbered, it is not necessary to study them in sequential order. We also
offer repeats of some modules to offer you maximum flexibility.
Parkinson’s Disease
Tablet Process Controls
The Skin – Properties and Role as a
Route of Administration
Schizophrenia and Antipsychotics
Tablet Coating
Dermal Route, Vehicles and Rheology
Subject Sessions
Depression and Antidepressants
Teamwork: Coating
Course Introduction and Objectives
Ask us about our free gap analysis service – we can help you determine which
modules would be of benefit to you and whether your experience or existing
qualifications will quality for an exemption from certain areas of study.
Anatomy & Physiology. Heart & Lungs
An Ex Inspector’s View of Solid Dose
Manufacture
Rectal and Vaginal Route of
Administration
Please contact Stella Pearson-Smith, our QP Administrator, for more information.
Introduction to the Heart and
Cardiovascular System
Introduction to Central
Neurotransmitter Systems
Nervous System
Anxiety and Anxiolytics
Cardiovascular Disease (Heart Attack)
PHARMACEUTICAL LAW
& ADMINISTRATION
Subject Sessions
Medicines Law – An Introduction
Mutual Recognition Agreements of
Inspection
Parallel Imports
Inflammation
Liquids, Creams, Ointments –
Processing and GMP Issues
Subject Sessions
Anti-Inflammatory Drugs
Teamwork: LCO QP Issues
Microorganisms – The What, Why & How
Contamination Control and Cleaning
Validation – Regulations and Guidelines
EU Law – An Overview
Global GMP Legislation
Recalls – EU and US Laws
Legislation in the EU Affecting
Clinical Trials
Regulatory Control of Starting
Materials
FORMULATION AND
PROCESSING, PART 1
The Role and Duties of the
Qualified Person
UK Medicines Legislation
Subject Sessions
US Pharmaceutical Law
Course Introduction and Objectives to
Formulation and Processing
The Non-Clinical Dossier/Toxicology
Medicines Legislation: Authorizations
for Manufacturing, Importing and
Wholesale Dealing
International Conference on
Harmonization – Organization, Role
and Recent GMP Activities
The Role of PIC/S (The Pharmaceutical
Inspection Cooperation Scheme)
Borderline Products
> MODULE 3a
Introduction to the Chemical
Functional Groups
Absorption, Distribution, Metabolism
and Elimination
Inspections and the Inspectorate
Workshop – Physicochemical
Properties of Drugs
Pharmacovigilance
Preformulation Issues
Medical Devices Legislation
Controlled Drugs
Route to Becoming a QP and Eligibility
(UK and other Member States)
Product Liability & Other Legislation to
be Considered
Pharmacokinetics and Concepts of
Bioavailability and Bioequivalence
Adverse Licensing
Keeping Up-To-Date
Reserve your place today:
Teamwork: Oral Liquids, Facility Design
Growing Microorganisms
Use of Drugs in Surgery
Comparison of Human and Veterinary
Legislation
The EU Marketing Authorization
Application
Format, Content – CTD
Marketing Authorization – Routes
and Variations
> MODULE 4
Teamwork: QP Scenarios – Oral Liquids
Gastrointestinal Disorders and Their
Treatment
European Legislation – Advanced
Therapy Medicinal Products
QP Issues for Oral Liquids
Oral Liquids
The Oral Route of Administration
> MODULE 3b
FORMULATION AND
PROCESSING, PART 2
Identification of Microorganisms
Microbiological Analysis of Water
Introduction to Sterile and Aseptic
Production
Pyrogens and Pyrogen Testing
Microbiological Evaluation of Raw
Materials and Non-Sterile Products
The Reality…Microbiological
Contamination and Spoilage of
Pharmaceuticals
The Kinetics of Sterilization; How
Bacteria Die
Principles of Preservation
Steam Sterilization and Good Autoclave
Practice
Antibiotics
Other Methods of Sterilization
An Overview of VHP Isolators
Overview of Formulation and Terminal
Filtration
web: www.nsf.org/info/pharma-training
Introduction to EudraLex Vol 4 Part II
Teamwork: Treasure Hunt from
EudraLex Vol 4 Part II
The Application of GMP to API
Manufacture, According to EudraLex
Vol 4 Part II
Facilities for APIs
Introduction to Sterile Products
Dry Heat Sterilization
Teamwork: The Responsibilities for QP
API Declarations
Rapid Microbiological Methods – An
Overview
Parenteral Route of Administration
Pharmaceutical Water Systems
Qualify Factors for APIs (Including
Biologics)
Teamwork: Pharmacopoeial
Monographs and APIs
Subject Sessions
Environmental Standards for Clean Rooms
Overview of Chemical Synthesis and a
Typical Bioprocess
Counting Microorganisms – Methods of
Enumeration
The Pharmaceutical Manufacturing
Environment – Where can
Microorganisms Exist?
Design, Qualification and Operation of
Clean Rooms
ACTIVE PHARMACEUTICAL
INGREDIENTS
Regulatory Control of APIs
QP Issues for Solid Dose and Capsules
PHARMACEUTICAL
MICROBIOLOGY
Diabetes and the Use of Insulin
> MODULE 1
Teamwork: Create a Control Strategy for
a QP in a Solid Dose Facility
Risk-based Decision Making in Steriles
Manufacturing
> MODULE 5
Preservation Efficacy Testing
Good Disinfection Practice
Sterilization – Principles and Methods
Biovalidation of Sterilization
tel: +44 (0) 1751 432999
GMP Utilities Used in API Manufacturing
including Water, Gases and Effluent
Removal/Treatment
API Impurities and Common API
Purification Techniques
Teamwork: Site Tours and Discussion
Groups
An Introduction to Biological and
Bioprocesses
GMP for Biopharmaceuticals
Teamwork: Why Bioprocessing is
Different to Chemical Synthesis
Premises for Biopharmaceutical
Manufacturing
Assessment of Antimicrobial Activity
Sterilization by Filtration
Teamwork: Facilities for APIs
Teamwork: Site Tours and Discussion
Groups
Overview of Key Steps in a Typical
Bioprocess
GMPs and Quality Assurance for
Excipients
email: QPpharma@nsf.org
> MODULE 2
MEDICINAL CHEMISTRY
& THERAPEUTICS
Subject Sessions
Introduction to Physiological Processes
Transmission Across a Synapse: Signal
Transmission in the Nervous System
Module Content
Autonomic Nervous System
Fundamentals of Solid Dose
Formulations
Good Gowning Practice
Sterility Testing
Aseptic Filling of Vials and Ampoules
Microbiological Validation of Clean Rooms
Teamwork: Powder Flow Properties
An Overview of Lyophilization
Capsules
Visual Inspection of Parenteral Products
Microbiological Environmental
Monitoring Methods
GMP Issues for Solid Dose
Manufacture
Process Simulation Trials and Their
Insight into Sterility Assurance
Teamwork: Facility Design
Case Study: Process Simulation Failures
Blending and Granulation
The Pulmonary Route of Administration
Teamwork: Blending and Granulation
Metered Dose Inhalers
Tablet Compression
An Overview of Parametric Release
Teamwork: Compression
Microbiological Risk Assessment
QP Scenarios – Root Cause Analysis
The NSF Health Sciences QP course is designed to meet the requirements
of the UK Study Guide.
Introduction to Drug Action
Each module is designed as a stand-alone course, so although the modules
are numbered, it is not necessary to study them in sequential order. We also
offer repeats of some modules to offer you maximum flexibility.
Parkinson’s Disease
Tablet Process Controls
The Skin – Properties and Role as a
Route of Administration
Schizophrenia and Antipsychotics
Tablet Coating
Dermal Route, Vehicles and Rheology
Subject Sessions
Depression and Antidepressants
Teamwork: Coating
Course Introduction and Objectives
Ask us about our free gap analysis service – we can help you determine which
modules would be of benefit to you and whether your experience or existing
qualifications will quality for an exemption from certain areas of study.
Anatomy & Physiology. Heart & Lungs
An Ex Inspector’s View of Solid Dose
Manufacture
Rectal and Vaginal Route of
Administration
Please contact Stella Pearson-Smith, our QP Administrator, for more information.
Introduction to the Heart and
Cardiovascular System
Introduction to Central
Neurotransmitter Systems
Nervous System
Anxiety and Anxiolytics
Cardiovascular Disease (Heart Attack)
PHARMACEUTICAL LAW
& ADMINISTRATION
Subject Sessions
Medicines Law – An Introduction
Mutual Recognition Agreements of
Inspection
Parallel Imports
Inflammation
Liquids, Creams, Ointments –
Processing and GMP Issues
Subject Sessions
Anti-Inflammatory Drugs
Teamwork: LCO QP Issues
Microorganisms – The What, Why & How
Contamination Control and Cleaning
Validation – Regulations and Guidelines
EU Law – An Overview
Global GMP Legislation
Recalls – EU and US Laws
Legislation in the EU Affecting
Clinical Trials
Regulatory Control of Starting
Materials
FORMULATION AND
PROCESSING, PART 1
The Role and Duties of the
Qualified Person
UK Medicines Legislation
Subject Sessions
US Pharmaceutical Law
Course Introduction and Objectives to
Formulation and Processing
The Non-Clinical Dossier/Toxicology
Medicines Legislation: Authorizations
for Manufacturing, Importing and
Wholesale Dealing
International Conference on
Harmonization – Organization, Role
and Recent GMP Activities
The Role of PIC/S (The Pharmaceutical
Inspection Cooperation Scheme)
Borderline Products
> MODULE 3a
Introduction to the Chemical
Functional Groups
Absorption, Distribution, Metabolism
and Elimination
Inspections and the Inspectorate
Workshop – Physicochemical
Properties of Drugs
Pharmacovigilance
Preformulation Issues
Medical Devices Legislation
Controlled Drugs
Route to Becoming a QP and Eligibility
(UK and other Member States)
Product Liability & Other Legislation to
be Considered
Pharmacokinetics and Concepts of
Bioavailability and Bioequivalence
Adverse Licensing
Keeping Up-To-Date
Reserve your place today:
Teamwork: Oral Liquids, Facility Design
Growing Microorganisms
Use of Drugs in Surgery
Comparison of Human and Veterinary
Legislation
The EU Marketing Authorization
Application
Format, Content – CTD
Marketing Authorization – Routes
and Variations
> MODULE 4
Teamwork: QP Scenarios – Oral Liquids
Gastrointestinal Disorders and Their
Treatment
European Legislation – Advanced
Therapy Medicinal Products
QP Issues for Oral Liquids
Oral Liquids
The Oral Route of Administration
> MODULE 3b
FORMULATION AND
PROCESSING, PART 2
Identification of Microorganisms
Microbiological Analysis of Water
Introduction to Sterile and Aseptic
Production
Pyrogens and Pyrogen Testing
Microbiological Evaluation of Raw
Materials and Non-Sterile Products
The Reality…Microbiological
Contamination and Spoilage of
Pharmaceuticals
The Kinetics of Sterilization; How
Bacteria Die
Principles of Preservation
Steam Sterilization and Good Autoclave
Practice
Antibiotics
Other Methods of Sterilization
An Overview of VHP Isolators
Overview of Formulation and Terminal
Filtration
web: www.nsf.org/info/pharma-training
Introduction to EudraLex Vol 4 Part II
Teamwork: Treasure Hunt from
EudraLex Vol 4 Part II
The Application of GMP to API
Manufacture, According to EudraLex
Vol 4 Part II
Facilities for APIs
Introduction to Sterile Products
Dry Heat Sterilization
Teamwork: The Responsibilities for QP
API Declarations
Rapid Microbiological Methods – An
Overview
Parenteral Route of Administration
Pharmaceutical Water Systems
Qualify Factors for APIs (Including
Biologics)
Teamwork: Pharmacopoeial
Monographs and APIs
Subject Sessions
Environmental Standards for Clean Rooms
Overview of Chemical Synthesis and a
Typical Bioprocess
Counting Microorganisms – Methods of
Enumeration
The Pharmaceutical Manufacturing
Environment – Where can
Microorganisms Exist?
Design, Qualification and Operation of
Clean Rooms
ACTIVE PHARMACEUTICAL
INGREDIENTS
Regulatory Control of APIs
QP Issues for Solid Dose and Capsules
PHARMACEUTICAL
MICROBIOLOGY
Diabetes and the Use of Insulin
> MODULE 1
Teamwork: Create a Control Strategy for
a QP in a Solid Dose Facility
Risk-based Decision Making in Steriles
Manufacturing
> MODULE 5
Preservation Efficacy Testing
Good Disinfection Practice
Sterilization – Principles and Methods
Biovalidation of Sterilization
tel: +44 (0) 1751 432999
GMP Utilities Used in API Manufacturing
including Water, Gases and Effluent
Removal/Treatment
API Impurities and Common API
Purification Techniques
Teamwork: Site Tours and Discussion
Groups
An Introduction to Biological and
Bioprocesses
GMP for Biopharmaceuticals
Teamwork: Why Bioprocessing is
Different to Chemical Synthesis
Premises for Biopharmaceutical
Manufacturing
Assessment of Antimicrobial Activity
Sterilization by Filtration
Teamwork: Facilities for APIs
Teamwork: Site Tours and Discussion
Groups
Overview of Key Steps in a Typical
Bioprocess
GMPs and Quality Assurance for
Excipients
email: QPpharma@nsf.org
Teamwork: An Overview of the Critical
Controls in the API Supply Chain
The Role and Intent of Pharmacopoeial
Monographs
GMPs and Quality Assurance for
Sterile APIs
Analytical Methods (Documentation,
Validation and Transfer)
Final Questions and Answers
Suspect Analytical Results (OOS, OOT
and Atypical Results)
> MODULE 6
MATHEMATICS &
STATISTICS
Subject Sessions
Summarizing and Visualizing Data
(Histograms, Probability Curves and
Box Plots)
Confidence in Your Means and
Proportions
Statistical Process Control
– Control Charts
Statistical Process Controls
– Cusum Charts
Attribute Control Charts for Count Data
and Other Useful Charts
Statistical Process Control – Fishbone
Diagrams and Pareto Charts
Conflict Management
Statistical Process Control – Process
Capability
Teamwork: Find it Exercise in ICH Q10
Labeling Regulations
ICH Q9 Quality Risk Management
Design of Packaging Components
Teamwork: Risk Management and QMS
PPM Supplier Considerations
Senior Management Roles and
Responsibilities with Regard to the QMS
Senior Management Roles and
Responsibilities – Aide Mémoire
Subject Sessions
Teamwork: Senior Management
Commitment to Quality
People
Appendices: Directive 2001/20/EC
Directive 2003/94/EC
Directive 2005/28/EC
Delegate Presentations
The Analytical Toolbox ‘Classical
Methods, KF, Electrochemical etc
Auditing to PS 9000 (including
checklist/aide mémoire)
Physico-chemical Testings of Solid
Dosage Forms (Hardness, Friability,
Dissolution)
Incoming Goods Sampling,
Specifications and Sampling Plans
Spectroscopy – Introduction
Delegate Presentations
UV/Visible Spectroscopy
Packaging GMPs, the 5Ps
Atomic Spectroscopy – Trace Metal
Analysis
Teamwork: Facility Design Exercise
Automated Safety Systems
Teamwork: QMS for Packing
Teamwork: Training and Development
of People
Documentation and Records
Data Integrity
Inspection Processes
Introduction to Change Control –
Planned Changes
Raman Spectroscopy
Teamwork: Inspection Exercise
Teamwork: Change Control
Introduction to Chromatography
Teamwork: Line Clearance, Where are
the risks?
Supply Chain Management
Infra-Red Spectroscopy (IR) and Near
Infra-Red (NIR)
Thin Layer Chromatography
High-Performance (Pressure) Liquid
Chromatography (HPLC)
Factors Affecting HPLC Performance
Gas Chromatography
Capillary Electrophoresis (CE) and Size
Exclusion Chromatography (SEC)
Teamwork: Line Clearance, How do
we combat risks?
Teamwork: Line Clearance
Serialization
Good Distribution Practice
Visit to Distributor
Teamwork: The Quality Management
of Materials
Introduction to GDP
Teamwork: GDP
Teamwork: Design Criteria
Production
Production Aide Mémoire
Teamwork: Production and QA
Integration – Converting Signals to
Analytical Results
QP Concerns, Interests on Wholesaler
ELISA, PCE and SDS Page
Pharmacognosy
Presentation Proposals for Department
Designs, QMS, BPR and Line Clearance
ISO2859 (BS6001, Mil. Std.) Inspection
by Attributes
Analysis of ‘Large’ Molecules
Feedback on week to date, key messages
Batch Release System
Mass Spectrometry (MS)
Statistical Testing – Two Groups (t-test)
Nuclear Magnetic Resonance (NMR)
Controlled Temperature Storage and
Distribution
Teamwork: Release Scenarios: To
Release or Not?
Statistical Testing – Three, or more,
samples (ANOVA)
Stability Testing
QP Life in Packing
Teamwork: QP Relationships
Anti Counterfeiting
Laboratory Control Systems
Group Work: Design an Audit
Aide Mémoire to Auditing Packing
Departments
Teamwork: Deviation Management
Six Sigma
‘Real World’ Experiences using Control
Charts
Statistical Testing – Outliers
(Dixon’s test)
Regression Analysis (includes 3 short
teamworks)
Equipment Qualification and
Maintenance
Water Testing: TOC and Conductivity
Pharmacy Visits
Multivariate Analysis
> MODULE 7
ANALYSIS & TESTING
Facilities, Equipment and Services
Management
Validation and Qualification Systems
Teamwork: Audits
Audits and Self-Inspections
Teamwork: Evaluation
QbD and Chemometrics
Experimental Design and Taguchi
> MODULE 8
PHARMACEUTICAL
PACKAGING
> MODULE 11
Container-Closure Systems
> MODULE 9
QUALITY MANAGEMENT
SYSTEMS
INVESTIGATIONAL
MEDICINAL PRODUCTS
PRACTICAL MODULE
Teamwork: What I Want to Know is…
Current Inspection Issues
Legislation in the EU Affecting Clinical
Trials
Q&A with MHRA Inspector & Panel
Key Differences between EU and US
Approach to Clinical Trials
Teamwork: Key Differences between
EU & USA
Teamwork: Key Differences between
Commercial and Clinical Manufacture
Specific EU GMP Guidance – Annex 13
Appendix: EudraLex Volume 4 Annex
13 – Investigational Medicinal Products
My Journey through the QP Viva
Process
Specific Documentation in Clinical
Trials
QP Declaration Template
Effective Management of Starting
Materials Including Comparators +
Extract from EudraLex Volume 4 Part 2
Education and Training of QPs
The Relationship Between the QP and
Regulatory Authorities
EU and UK Legislation and Guidelines:
An Update
Human Error
Leading with Influence
GMP Issues for Clinical Trial
Manufacturing
The Role of the IMP QP
Practical Implications of Importation of
Clinical Supplies
The QP as a Change Agent
The QP: What it is like in Real Life
The Qualified Person: Code of Practice
Keeping Up-to-Date
Testing and Specifications
GMP issues in Clinical Trial Packaging
Operations
Interactive Voice Response Systems
(IVRS)
Biologics
QP Batch Release Scenarios
web: www.nsf.org/info/pharma-training
The QP Application Process
Teamwork: QP Batch Release
Scenarios
Analysis and Preformulation
Reserve your place today:
The Legal Duties of the Qualified Person
Essentials of a Quality Management
System in the Development of
Medicines (ICH Q10) + reference
paper
Teamwork: Quality Management
System Elements
Teamwork: Stability
Subject Sessions
Risk-Based Decision Making for the QP
Formulation and Processing
Sampling and Sample Management
ROLE & PROFESSIONAL
DUTIES OF THE QP
What Gives a QP Confidence?
Integration of Quality Systems Across
Product Lifecycle
Stability Testing
> MODULE 12
Introduction to ICH Q8, Q9 and Q10
and Validation
Subject Sessions
The Analytical Laboratory (GCLP)
What’s New in CTs?
Batch Certification by the QP – Annex 16
Teamwork: Principles of QA and QMS
– Overview
Overview of Materials
Distribution of Clinical Supplies
The Role of the EU QP for IMPs
Introduction and Objectives
Subject Sessions
Teamwork: Audit Observations or
more QP Batch Release Scenarios
GCP and GMP Interface Areas
Subject Sessions
Sterile Products
Teamwork: Cleaning
Contractual Relationships and
Technical Agreements
Subject Sessions
Teamwork: Introduction to Material Packs
Cleaning Validation and Verification
Scene Setting: What is a Clinical Trial?
Teamwork: Importation
> MODULE 10
Teamwork: Tic Tac Exercise
The View from a contract Clinical
Trials Packager
tel: +44 (0) 1751 432999
LPH-372-1215
email: QPpharma@nsf.org
Teamwork: An Overview of the Critical
Controls in the API Supply Chain
The Role and Intent of Pharmacopoeial
Monographs
GMPs and Quality Assurance for
Sterile APIs
Analytical Methods (Documentation,
Validation and Transfer)
Final Questions and Answers
Suspect Analytical Results (OOS, OOT
and Atypical Results)
> MODULE 6
MATHEMATICS &
STATISTICS
Subject Sessions
Summarizing and Visualizing Data
(Histograms, Probability Curves and
Box Plots)
Confidence in Your Means and
Proportions
Statistical Process Control
– Control Charts
Statistical Process Controls
– Cusum Charts
Attribute Control Charts for Count Data
and Other Useful Charts
Statistical Process Control – Fishbone
Diagrams and Pareto Charts
Conflict Management
Statistical Process Control – Process
Capability
Teamwork: Find it Exercise in ICH Q10
Labeling Regulations
ICH Q9 Quality Risk Management
Design of Packaging Components
Teamwork: Risk Management and QMS
PPM Supplier Considerations
Senior Management Roles and
Responsibilities with Regard to the QMS
Senior Management Roles and
Responsibilities – Aide Mémoire
Subject Sessions
Teamwork: Senior Management
Commitment to Quality
People
Appendices: Directive 2001/20/EC
Directive 2003/94/EC
Directive 2005/28/EC
Delegate Presentations
The Analytical Toolbox ‘Classical
Methods, KF, Electrochemical etc
Auditing to PS 9000 (including
checklist/aide mémoire)
Physico-chemical Testings of Solid
Dosage Forms (Hardness, Friability,
Dissolution)
Incoming Goods Sampling,
Specifications and Sampling Plans
Spectroscopy – Introduction
Delegate Presentations
UV/Visible Spectroscopy
Packaging GMPs, the 5Ps
Atomic Spectroscopy – Trace Metal
Analysis
Teamwork: Facility Design Exercise
Automated Safety Systems
Teamwork: QMS for Packing
Teamwork: Training and Development
of People
Documentation and Records
Data Integrity
Inspection Processes
Introduction to Change Control –
Planned Changes
Raman Spectroscopy
Teamwork: Inspection Exercise
Teamwork: Change Control
Introduction to Chromatography
Teamwork: Line Clearance, Where are
the risks?
Supply Chain Management
Infra-Red Spectroscopy (IR) and Near
Infra-Red (NIR)
Thin Layer Chromatography
High-Performance (Pressure) Liquid
Chromatography (HPLC)
Factors Affecting HPLC Performance
Gas Chromatography
Capillary Electrophoresis (CE) and Size
Exclusion Chromatography (SEC)
Teamwork: Line Clearance, How do
we combat risks?
Teamwork: Line Clearance
Serialization
Good Distribution Practice
Visit to Distributor
Teamwork: The Quality Management
of Materials
Introduction to GDP
Teamwork: GDP
Teamwork: Design Criteria
Production
Production Aide Mémoire
Teamwork: Production and QA
Integration – Converting Signals to
Analytical Results
QP Concerns, Interests on Wholesaler
ELISA, PCE and SDS Page
Pharmacognosy
Presentation Proposals for Department
Designs, QMS, BPR and Line Clearance
ISO2859 (BS6001, Mil. Std.) Inspection
by Attributes
Analysis of ‘Large’ Molecules
Feedback on week to date, key messages
Batch Release System
Mass Spectrometry (MS)
Statistical Testing – Two Groups (t-test)
Nuclear Magnetic Resonance (NMR)
Controlled Temperature Storage and
Distribution
Teamwork: Release Scenarios: To
Release or Not?
Statistical Testing – Three, or more,
samples (ANOVA)
Stability Testing
QP Life in Packing
Teamwork: QP Relationships
Anti Counterfeiting
Laboratory Control Systems
Group Work: Design an Audit
Aide Mémoire to Auditing Packing
Departments
Teamwork: Deviation Management
Six Sigma
‘Real World’ Experiences using Control
Charts
Statistical Testing – Outliers
(Dixon’s test)
Regression Analysis (includes 3 short
teamworks)
Equipment Qualification and
Maintenance
Water Testing: TOC and Conductivity
Pharmacy Visits
Multivariate Analysis
> MODULE 7
ANALYSIS & TESTING
Facilities, Equipment and Services
Management
Validation and Qualification Systems
Teamwork: Audits
Audits and Self-Inspections
Teamwork: Evaluation
QbD and Chemometrics
Experimental Design and Taguchi
> MODULE 8
PHARMACEUTICAL
PACKAGING
> MODULE 11
Container-Closure Systems
> MODULE 9
QUALITY MANAGEMENT
SYSTEMS
INVESTIGATIONAL
MEDICINAL PRODUCTS
PRACTICAL MODULE
Teamwork: What I Want to Know is…
Current Inspection Issues
Legislation in the EU Affecting Clinical
Trials
Q&A with MHRA Inspector & Panel
Key Differences between EU and US
Approach to Clinical Trials
Teamwork: Key Differences between
EU & USA
Teamwork: Key Differences between
Commercial and Clinical Manufacture
Specific EU GMP Guidance – Annex 13
Appendix: EudraLex Volume 4 Annex
13 – Investigational Medicinal Products
My Journey through the QP Viva
Process
Specific Documentation in Clinical
Trials
QP Declaration Template
Effective Management of Starting
Materials Including Comparators +
Extract from EudraLex Volume 4 Part 2
Education and Training of QPs
The Relationship Between the QP and
Regulatory Authorities
EU and UK Legislation and Guidelines:
An Update
Human Error
Leading with Influence
GMP Issues for Clinical Trial
Manufacturing
The Role of the IMP QP
Practical Implications of Importation of
Clinical Supplies
The QP as a Change Agent
The QP: What it is like in Real Life
The Qualified Person: Code of Practice
Keeping Up-to-Date
Testing and Specifications
GMP issues in Clinical Trial Packaging
Operations
Interactive Voice Response Systems
(IVRS)
Biologics
QP Batch Release Scenarios
web: www.nsf.org/info/pharma-training
The QP Application Process
Teamwork: QP Batch Release
Scenarios
Analysis and Preformulation
Reserve your place today:
The Legal Duties of the Qualified Person
Essentials of a Quality Management
System in the Development of
Medicines (ICH Q10) + reference
paper
Teamwork: Quality Management
System Elements
Teamwork: Stability
Subject Sessions
Risk-Based Decision Making for the QP
Formulation and Processing
Sampling and Sample Management
ROLE & PROFESSIONAL
DUTIES OF THE QP
What Gives a QP Confidence?
Integration of Quality Systems Across
Product Lifecycle
Stability Testing
> MODULE 12
Introduction to ICH Q8, Q9 and Q10
and Validation
Subject Sessions
The Analytical Laboratory (GCLP)
What’s New in CTs?
Batch Certification by the QP – Annex 16
Teamwork: Principles of QA and QMS
– Overview
Overview of Materials
Distribution of Clinical Supplies
The Role of the EU QP for IMPs
Introduction and Objectives
Subject Sessions
Teamwork: Audit Observations or
more QP Batch Release Scenarios
GCP and GMP Interface Areas
Subject Sessions
Sterile Products
Teamwork: Cleaning
Contractual Relationships and
Technical Agreements
Subject Sessions
Teamwork: Introduction to Material Packs
Cleaning Validation and Verification
Scene Setting: What is a Clinical Trial?
Teamwork: Importation
> MODULE 10
Teamwork: Tic Tac Exercise
The View from a contract Clinical
Trials Packager
tel: +44 (0) 1751 432999
LPH-372-1215
email: QPpharma@nsf.org
The right people. The right solution. The first time.™
Prospective QPs – Gap Analysis Service
If you’re considering training as a QP, you will need to plan your study program and make sure you have the knowledge and
experience required by the UK Study Guide. Depending on your own individual circumstances, it may not be necessary for
you to attend every module.
We are happy to help you assess your needs by providing a gap analysis based on an evaluation of your CV, and/or we
can provide our unique self-assessment tool which helps you to carry out your own gap analysis. We will then provide you
with a written recommendation on which modules would be necessary or of professional benefit, with specific reference to
your background.
Some requirements can be addressed by self-study or work experience, and others will require formal study. We are always
available to discuss your requirements and answer any questions you may have.
There is no charge for this service. Contact our QP Course Administrator at QPpharma@nsf.org for more information.
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K Stud
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Qualified Person Training – Provisional Module Booking
When you have established which modules you need to attend, we can hold provisional places for you without obligation.
Planning your training program in this way ensures that you will receive relevant pre-course reminders and information.
Remember also that delegates who sign up for a minimum of four QP modules with us will be assigned a personal tutor, who
will be on hand throughout your training to offer guidance and support.
Please indicate below which modules you’re interested in and return the form to our QP Course Administrator at
QPpharma@nsf.org. We will then make provisional bookings for you to make sure you don’t miss your preferred dates.
Your Details
Delegate: Title – Mr/Mrs/Ms/Dr/Other (please circle)
First NameLast Name
Job Title
Company Address
Postcode
Telephone Number
No
Email Address
Title
Date
1
Pharmaceutical Law & Administration
2
Medicinal Chemistry & Therapeutics
3a
Pharmaceutical Formulation & Processing, Part 1
16-20 January 2017
3b
Pharmaceutical Formulation & Processing, Part 2
6-10 March 2017
4
Pharmaceutical Microbiology
15-19 May 2017
5
Active Pharmaceutical Ingredients
6
Mathematics & Statistics
11-14 September 2017
7
Analysis & Testing
13-17 November 2017
8
Pharmaceutical Packaging
9
Quality Management Systems
10
Practical
14-18 May 2018
11
Investigational Medicinal Products
11-14 June 2018
12
Role & Professional Duties of the Qualified Person
Please reserve
me a place on
this course
17-21 October 2016 | 16-20 October 2017
14-18 November 2016
12-16 June 2017 | 25-29 June 2018
15-19 January 2018
3-7 April 2017 | 12-16 March 2018
17-20 July 2017 | 23-26 July 2018
emailQPpharma@nsf.org
www.nsf.org
tel
+44 (0) 1751 432 999
fax
+44 (0) 1751 432 450
postThe Georgian House, 22-24 West End,
Kirkbymoorside, York, UK, YO62 6AF
LPH-372-1215
The right people. The right solution. The first time.™
Qualified Person Training
October 2016 to July 2018
Approved
training
Title
Date
Repeated
Modules Date
1
Pharmaceutical Law &
Administration
17-21 October 2016
16-20 October 2017
2
Medicinal Chemistry &
Therapeutics
14-18 November 2016
3a
Pharmaceutical
Formulation &
Processing, Part 1
16-20 January 2017
No
3b
Pharmaceutical
Formulation &
Processing, Part 2
6-10 March 2017
4
Pharmaceutical
Microbiology
15-19 May 2017
5
Active Pharmaceutical
Ingredients
12-16 June 2017
6
Mathematics & Statistics
11-14 September 2017
7
Analysis & Testing
13-17 November 2017
8
Pharmaceutical
Packaging
15-19 January 2018
9
Quality Management
Systems
12-16 March 2018
10
Practical
14-18 May 2018
11
Investigational
Medicinal Products
11-14 June 2018
12
Role & Professional
Duties of the Qualified
Person
23-26 July 2018
Alternative Training
(part of QP Syllabus)
A-Z of Sterile Products
Manufacture
> 3-6 October 2016
> 13-17 March 2017
> 26-30 June 2017
> 27 November-1 December 2017
25-29 June 2018
Statistics for Ongoing
Process Verification
> 11-12 October 2016
3-7 April 2017
GMP for Clinical Trials
Manufacture and Supply
> 6-9 November 2017
17-20 July 2017
Recommended Training (not part of QP Syllabus)
Pharmaceutical GMP Audits and Self-Inspections
Risk-Based Decision Making for Quality Professionals and QPs
GMP for Biological and Biotechnology Products
QP series 14 Module dates-Update.indd 1
08/07/2016 16:38
QP Module Planner
We acknowledge that it isn’t always easy to fit training around your work schedule. To help you with this, we run repeats of
certain QP modules. There are also some courses from our main public training program which provide suitable alternatives to
the QP modules indicated.
12
Role &
Professional
Duties of
the QP
11
Investigational
Medicinal
Products
1
Pharmaceutical
Law &
Administration
23-26 July
2018
17-21 October
2016
11-14 June
2018
10
GMP for
Clinical Trials
Manufacture
and Supply
Practical
Module
14-18 May
2018
Role &
Professional
Duties of
the QP
17-20 July
2017
6-9 November
2017
2
Pharmaceutical
Law &
Administration
Medicinal
Chemistry &
Therapeutics
16-20 October
2017
14-18 November
2016
KEY
9
3a
Quality
Management
Systems
Quality
Management
Systems
12-16 March
2018
3-7 April
2017
Series Modules – our scheduled
program of Modules 1-12
Pharmaceutical
Formulation &
Processing, Part 1
16-20 January
2017
‘Repeat’ Modules – additional dates to
give you extra flexibility
A-Z of
Sterile Products
Manufacture
Alternative Training – courses from
our public training program which
provide you with similar
knowledge related to
the QP module*
8
Pharmaceutical
Packaging
15-19 January
2018
7
Analysis &
Testing
13-17 November
2017
Statistics for
Ongoing Process
Verification
Active
Pharmaceutical
Ingredients
11-12 October
2016
25-29 June
2018
3-6 October 2016
13-17 March 2017
26-30 June 2017
27 Nov-1 Dec
2017
Pharmaceutical
Formulation &
Processing, Part 2
6-10 March
2017
4
Pharmaceutical
Microbiology
15-19 May
2017
6
5
Mathematics
& Statistics
Active
Pharmaceutical
Ingredients
11-14 September
2017
3b
12-16 June
2017
*For specific details or further advice contact Stella Pearson-Smith (QPpharma@nsf.org)
The information contained in this brochure is correct at the time of printing and is published in good faith. We reserve the right to make any changes which may become necessary.
emailQPpharma@nsf.org
www.nsf.org
tel
+44 (0) 1751 432 999
fax
+44 (0) 1751 432 450
postThe Georgian House, 22-24 West End,
Kirkbymoorside, York, UK, YO62 6AF
LPH-372-1215
QP series 14 Module dates-Update.indd 2
08/07/2016 16:38
The right people. The right solution. The first time.™
The Experience of QP Training with
NSF Health Sciences
See what some former delegates have to say – they’re people who see it from your
perspective. Read on to get a flavor of how it feels to be part of the NSF QP program.
James Culyer, Bard Pharmaceuticals
The reason for choosing NSF was quite
simply that there was no choice. As
a company we had a long-standing
relationship with NSF; all 7 of the site
QPs had studied and qualified with
them, including my manager and the
Quality Director himself. The relationship
spanned many years and had become
a two-way process, with many of our
QPs routinely involved in delivering
material and sharing experiences as
industry presenters at NSF’s many and
varied training courses. There was a
deep trust in the abilities of both parties
to deliver exactly what was needed
and the thought of going elsewhere
for QP training with no understanding
of the capabilities, knowledge of the
course materials, and no experience
of the approach taken was not even
entertained. To reiterate, NSF was quite
simply the first and only choice.
I needn’t have worried; the courses
themselves are extremely informative
and quite simply great fun. The
atmosphere is relaxed and informal and
the speakers experts in their respective
fields. Many hints and tips for survival
were gladly given; how to handle the
revision workload, how to survive the
exams, how to get the most out of the
courses – basically, all the essentials!
Also, from the very first morning of the
first course you start the networking
process, and that is just a formal way
of saying you start making new friends.
And that is one of the best things about
the NSF approach to QP development,
the huge emphasis on networking;
practically every aspect of the course
– the training techniques, the venues,
the ‘extra-curricular’ activities – are all
based around encouraging you to build
a broad and long-lasting network of
contacts that will serve you through the
viva process and beyond, throughout
the rest of your career.
The other great thing about the NSF QP
courses is the personal tutor system.
Once you sign up for at least four of
the QP modules you are automatically
assigned a personal tutor. This will be
one of the NSF team members actively
involved in the QP training courses,
and they will inevitably have acted as
a QP at some point in their career.
They remain an ever-present source of
information and guidance right up to
the point you sit, and hopefully pass,
your viva.
In the months leading up to the viva
process NSF offers one further service,
the mock viva. The extremely gruelling
three hour session serves to identify
the gaps you have that need filling,
your ability to put yourself across in
a viva experience, and the overall
manner in which you present yourself
and approach the various different
types of viva questions and scenarios. I
remember my own mock viva very well,
and remember how helpful it was in
focussing my revision topics leading up
to the real thing a few short weeks later.
So overall I don’t think you can do
better than to choose NSF as the
training provider for the QP program.
Their focus is 100% on getting you
through, successfully, first time. The
structure of the courses and course
material, the social aspects of the
modules, the emphasis on networking,
the tutoring and mentoring, and all in
all the supportive nature of the service
they provide gives you the best chance
possible. All you need to do is turn up
on the day and pass the thing!
Shawn Murtough, Penn Pharmaceuticals
NSF provides first-class training services that will greatly assist any prospective candidate in their quest for eligibility to act as
a Qualified Person.
The structure of the program allows candidates to join and leave at any point, which provides flexibility in meeting your
training needs against a busy work schedule. The content revisits key themes on different modules to ensure a thorough
understanding of how certain aspects interlink between the different modules. The style of teaching and learning that NSF
promote is interactive, meaning that core messages are first delivered by traditional methods and then emphasised through
teamwork sessions which greatly assist full understanding and comprehension.
NSF training always takes place in high quality venues, with the trainers being recognised as industry experts. I would have
no hesitation in recommending NSF as the leading training provider in respect of the QP study guide.
Ian Birch, Roche Pharma
Leen van de Water, Pannoc
For me the Qualified Person training at NSF was not just the only possible
way to become a QP in Belgium. I’m still the only non-pharmacist as a QP in
Belgium at the moment. It was a one out of a thousand opportunity.
Not only did I gain a lot of theoretical and practical knowledge about the
different pillars of a pharmaceutical company: pharmaceutical legislation,
formulating, processing, APIs, analysing and testing, packaging, the quality
management system… for me the opportunity to network, get in touch with
new people, and talk about problems and solutions was as important as
the knowledge.
Also the opportunity to develop the necessary soft skills for a QP was
important, and it definitely brought my English to a higher level.
The Qualified Person training of NSF made me the QP I am today, with a
backpack full of knowledge, skills and the necessary network to make the very
important decision, to release or not to release.
I hope a lot of Belgians follow my footsteps to become a QP via the NSF
training as a non-pharmacist.
NSF provided me with the most
comprehensive QP training I could
have hoped for. I can understand why
the training is held in such high regard,
as the tutors’ delivery, experience and
importantly, their focus on personal
development, is exceptional.
The environment in which the course
is run allowed me to develop a strong
and effective network with other quality
professionals, which you can’t put a
price on!
NSF are an example of ‘best in class’
and I believe their approach to training
produces quality professionals that can
draw on experience from all areas of
the industry.
David Franks, Reckitt Benckiser Pharmaceuticals
Why did I choose NSF?
NSF are renowned through the UK
(and beyond) industry as leaders in
training QPs.
From the first module you will know that
a friendly, relaxed (but intense!) training
course will meet your expectations.
The training is structured in a way that
you get to apply your knowledge in
scenario-based break-out sessions,
and you get to work with a network of
quality professionals, which I personally
have taken out of the classroom and
into my workplace.
If I could offer any words of advice,
experience or wisdom to a new
starter on the course, what would
I say?
Use the training materials and gain a
network with fellow delegates. Find
the time during and after the course
to build up that network. It will get you
success beyond the viva.
Make use of your tutor as much as
possible. My personal tutor was very
knowledgeable of my company and
former delegates and personnel,
which really helped in understanding
about my company’s dosage forms.
She was a great help and really
encouraged me throughout the
course. She was available when I
needed her, in and outside of normal
hours. She was the shoulder to cry on
and the boot up the backside when it
was needed!
What have I enjoyed most about the
training course?
The course tutors have made the
course successful by presenting
it in a way that builds up from the
foundations to a level that will give you
the confidence you need to become a
QP. The optional evening sessions also
help with the soft skills needed in the
role. I enjoyed this the most, as it not
only made filling in the QP application
easy, it has given me the knowledge
and self-belief to perform the QP duties
after I passed the viva.
Scan the QR code
to see what our
delegates say about
training with NSF
Health Sciences
(or go to www.youtube.com/
watch?v=WQPJa0-_S14).
emailQPpharma@nsf.org
www.nsf.org
tel
+44 (0) 1751 432 999
fax
+44 (0) 1751 432 450
postThe Georgian House, 22-24 West End,
Kirkbymoorside, York, UK, YO62 6AF
LPH-372-1215
The right people. The right solution. The first time.™
Prospective QPs Typical Questions Asked
Do I need to attend all the
modules?
No, unless you wish to aim for the Postgraduate Diploma or MSc,
modules can be selected as required.
How can I decide which
modules to attend?
Delegates are offered a free Gap Analysis with a course tutor.
Guidance can be given during a face-to-face interview or remotely
after providing a detailed CV for review.
How long does the course
take?
This depends on how many modules the delegates wish to attend and
where these fall in the series. A full series typically takes 18 months but
some delegates prefer to spread the course over 2 series. Flexibility is
the name of the game!
How do I enrol for the
Postgraduate Certificate?
Delegates should register their interest with their Tutor and/or QP
Course Administrator. The University of Strathclyde will be informed
and will subsequently coordinate the qualification direct with the
delegate. The requirements for the Certificate are…
How do I enrol for the
Postgraduate
Diploma/MSc?
>attend 3 foundation modules and 3 of choice, perform
satisfactorily in the module assessments, sit the Certificate
exam at the University
The University of Strathclyde coordinates their qualification directly
with the delegate. Typically the requirements for the Diploma are…
>attend all modules, perform satisfactorily in the module
assessments, sit the Diploma exams at the University
The MSc requires the above plus a workplace thesis/project, approved
by the Course Director at the University.
Do all modules cost the
same?
No, some are 5 days in duration and some are 4 days. In addition
different venues (such as the practical module in Glasgow) can impact
on the course costs.
Once the series is finished
do I still have use of your
advice and consultancy?
Yes. Past delegates on our courses are always welcome to contact us
with comments or queries for opinion or advice. This is a free service
and we are always pleased to keep in touch with past delegates.
What is the success rate
of your delegates at viva?
Information to date shows a pass rate of 96% for delegates we
have trained.
I’ve heard about the
Personal Tutor System,
what is it?
Delegates who attend 4 or more modules are classed as “core”
delegates. This brings additional benefits to the delegate…
>core delegates are assigned a Personal Tutor who offers
support and guidance through regular meetings on
modules regarding the application process and experience
requirements for the viva
>core delegates are also offered a free revision interview 6-8
weeks before their viva to assess the delegate’s readiness for
the viva
>review of the QP application form prior to submitting to the
Joint Professional Bodies
Is there an exam for each
module?
Yes, the exams usually take place prior to the next module, on the
Sunday evening at 18.30. Some modules however are assessed by
dissertation and a deadline provided for submission.
I don’t want to be a QP
but this looks like great
training, can I attend?
Yes. Not everyone attending the modules is looking to become a QP.
Many use the training to develop as technical managers or as part of
their continuing professional development.
Do I need a sponsor?
Yes. Ideally a QP and someone who knows you and your roles and
responsibilities well. Someone who can provide you with ongoing
support through your training. Your Sponsor will be required to complete
a Sponsor’s Report to accompany your QP application form. NSF
encourage Sponsors to visit a module and meet the Personal Tutor to
check on progress.
emailQPpharma@nsf.org
www.nsf.org
tel
+44 (0) 1751 432 999
fax
+44 (0) 1751 432 450
postThe Georgian House, 22-24 West End,
Kirkbymoorside, York, UK, YO62 6AF
LPH-372-1215
The right people. The right solution. The first time.™
Qualified Person Training Course Fees
Approved
training
October 2016 to July 2018
No
Title
Days
Fee £
1
Pharmaceutical Law & Administration
5 days
3395
2
Medicinal Chemistry & Therapeutics
5 days
3395
3a
Pharmaceutical Formulation & Processing, Part 1
5 days
3395
3b
Pharmaceutical Formulation & Processing, Part 2
5 days
3395
4
Pharmaceutical Microbiology
5 days
3395
5
Active Pharmaceutical Ingredients
4.5 days
2880
6
Mathematics & Statistics
4 days
2750
7
Analysis & Testing
5 days
3395
8
Pharmaceutical Packaging
5 days
3395
9
Quality Management Systems
5 days
3395
10
Practical
5 days
3575
11
Investigational Medicinal Products
4 days
2750
12
Role & Professional Duties of the Qualified Person
4 days
2750
Reserve your place today
visit www.nsf.org/info/pharma-training, call us on
+44 (0) 1751 432999 or email us at QPpharma@nsf.org
What’s Included in the Module Fees
Course fee includes tuition, full course documentation, any visits arranged, attendance certificate and assessments as well as
attendance at our QP skills sessions. Daytime conference facilities, lunches, refreshments and the formal course dinner are
always included. Hotel accommodation and other evening meals are not included, but we do have specially negotiated Bed and
Breakfast rates with all of the hotels.
We know that we are in the fortunate position of being considered the premier provider of QP training. We also know that we
are by no means the cheapest – although we like to think that you get what you pay for. Nonetheless, we appreciate that the
pharmaceutical industry is going through a period of belt tightening and, whilst QP training represents a critical undertaking
which will only be done once and so should be done right, we understand that budgets are not limitless.
We Would Like to Help by Offering the Following Discounts
> For companies sending more than one delegate from the same site to any of our
modules, the second attendee will receive a 20% discount on the course fee;
third and subsequent delegates receive a 50% discount
> 50% discount is available for Regulatory Authorities and UK National Health
Service employees
> Discounts may be available at the discretion of the Executive Directors, on a
case by case basis for self-funding individuals and to support charities
How to Reserve a Place
To provisionally reserve a place on the series, any individual modules
or for further information please contact our QP Course Administrator at
QPpharma@nsf.org.
Online Reservation
Provisional and firm bookings can be made via our website
www.nsf.org/info/pharma-training
The information contained in this brochure is correct at the time
of printing and is published in good faith. We reserve the right to
make any changes which may become necessary.
emailQPpharma@nsf.org
www.nsf.org
tel
+44 (0) 1751 432 999
fax
+44 (0) 1751 432 450
postThe Georgian House, 22-24 West End,
Kirkbymoorside, York, UK, YO62 6AF
LPH-372-1215
Add your name to the NSF roll of honour
– all these people have trained with us
♦
The role
>Highly interactive, face-to-face education
>Revision interview
>Training to do the job, not just pass an exam
>Sponsor/tutor meetings on modules
>Flexible courses start and stop to suit you
>Postgraduate qualifications as necessary from Postgraduate
Certificate to MSc
>Most successful QP training course available
>Alumni organization of experienced fellow QPs sharing
the same training
>CPD
>Ongoing access to NSF and its consultants
What We Offer You
>Help in formulating your own training and experience plan
>Use of the unique gap analysis tool
>Greatest opportunity for success
> Unequalled networking opportunity
> Complete, detailed training and reference materials
Scan the QR code (or go to
http://youtu.be/bmjjFhAbNUM)
to find out more about QP training
with NSF Health Sciences.
Reserve your place: web: www.nsf.org/info/pharma-training
For delegates attending all 12 QP modules, a 50% reduction in
course fees for recommended additional courses including…
> GMP for Biological and Biotechnology Products
The skills
> 12 customized reference books covering all course
notes, with no further background reading required
♦
> Exams for benchmarking or postgraduate study
> Effective Pharmaceutical Audits and Self-Inspections
(An IRCA Certified Pharmaceutical QMS Auditor/Lead
Auditor Course)
The knowledge
> Certificates of attendance
>Review of application form
♦
> Risk-Based Decision Making for Quality Professionals and QPs
> Visits
>Viva prep sessions including scenario tutorials and
decision making
> Daytime conference facilities
> Uniquely, you have the time required to learn and thoroughly
understand:
Conflict management
> Risk-Based Decision Making in Sterile Products Manufacture
> Lunch and refreshments
And others
> Course dinner
♦
> For delegates paying for all modules in advance, a discount of 15%
off the total cost will be applied (candidates paying in advance will
be excluded from the multiple delegate discounts available)
♦
Special bed and breakfast rates are available for
NSF delegates (not included in course fees)
>Supported by lecturers from one of the country’s top Schools
of Pharmacy
> Other rewards and discounts are available. Please talk to Stella
Pearson-Smith, QP Administrator, for current offers.
Decision making
Discounts Available
♦
How to Reserve a Place
> 20% for second delegate attending same module
from same company
Leadership
apid learning
R
techniques
To provisionally reserve a place on the series or any individual
modules, or for further information, please contact our QP Course
Administrator at QPpharma@nsf.org.
♦
> 50% for third and subsequent delegates attending
same module from same company
Assertiveness
Online Reservation
>Unequalled training for highly experienced industrial experts and
experienced QPs
> 50% for NHS and Regulatory Authorities
Coaching and mentoring
♦
Provisional and firm bookings can be made via our
website www.nsf.org/info/pharma-training
♦
> Discounts also available, at the discretion of the
course leaders, for self-funding individuals and for
certain charities
The information contained in this brochure is correct at the time of printing and is published in good faith. We reserve the right to make any changes which may become necessary.
Presentation techniques
♦
email QPpharma@nsf.org
♦
+44 (0) 1751 432 999
tel
What We Offer – The Course
+44 (0) 1751 432 450
>New technical, essential skills training
fax
>Support for delegates and sponsors
post
>Individual training advice
The Georgian House,
22-24 West End, Kirkbymoorside,
York, UK, YO62 6AF
>Essential CPD for all, not only QPs
>A personal assigned tutor available throughout
the program
LPH-372-1215
>More than meets the requirements of the UK QP Study Guide
and 2001/82 EC, 2001/83 EC
(delegates taking four or more modules)
www.nsf.org
16/12/2015 13:21
www.nsf.org
The right people. The right solution. The first time.™
With Opportunity for Postgraduate Qualification
Qualified Person and
Continuing Professional
Development Training
2
>12 modules over 21 months
What We Offer Core QPs
168.5mm
The Aspiring QP and
Technical Professional
20mm
The course provides practical, face-to-face tuition in sufficient depth to prepare you fully for the challenges ahead. The plain fact is
that you are more likely to become a QP with us than with any other training provider.
FOLD
We have been running Qualified Person (QP) training courses since 1990
and they are generally considered to be the best available – our QPs are very
highly regarded within the industry and their status is recognised by many
other countries including Austria, Belgium, Denmark, Hungary, Ireland, Jordan,
Malta, The Netherlands, Norway and Switzerland.
Nigel Adams • Gareth Adlam • Stuart Allen • Paul Anderson • Richard Angwin • Kate Barker • Lynda
Baker • Suzanne Ball • Justin Barry • Cathy Bateman • Daniel Bell • David Belshaw • Christine Bennett •
Neil Bennett • Dale Billingsley • Sonia Bradford • Lynn Bryan • Philip Butson • Samantha Clack • Robert
Clarke • Neil Connor • Peter Cormack • Roy Cowell • Bruce Cuthbertson • Kris Davé • Faith Daykin •
Martin Dearden • Peter Deegan • Karam Dhaliwal • Robert Dilks • Elaine Dymond • David Earl • Sam
Elcomb • Grant Elliott • Clare Embley • Elizabeth Evans • Marcus Evans • Karl Fry • Richard Funnell
• Mayuur Gohill • Amanda Hall • Johan Havinga • Paul Henly • Nick Hill • Nigel Holcombe • Judith
Hoodless • Mark Hughes • Sandra Illsley • Ronald Imhoff • Mike Irving • Ian Jackson • Sukhbinder
Jaiswal • Hazel James • Phil Jenkinson • John Johnson • Adam Jones • Jantine Jonkman • Julian Kay
• Tony Kem • Mark Kind • Boudy König • Sheila Lachut • Bob Lambert • Trevor Lees • Fraser Leslie •
Brian Lewis • Debbie Lloyd • Alison Lockett • Tony Loeffen • Veronika Lothian • Martin Lush • Karen
Lynch • Fiona MacIntyre • Tony Mayhall • Grame McBurney • Robert McConnell • Thomas McHale •
Fiona McLaren • Wallace McRobert • Kim Morwood • Stephen Moss • Derek Murphy • Shirley Mutch
• Anneke Nederbragt • Deborah Nugent • Russell Nugent • Paul O’Connor • Brendan O’Dorman •
Tony Osbourne • David Palmer • Philip Parry • Zen Pawlack • Andrew Pentelow • Anna Pickering • Ian
Pounder • Martnie Powell • Nick Precious • David Preston • David Price • Neil Raw • Annie Rietveld •
Mike Roberts • David Robinson • Richard Rogers • David Ross • Michael Rowe • Monika Sauter • John
Seager • Jane Shaw • Stephen Simpson • Cate Sims • Richard Smalley • Robert Smith • Scott Smith •
Andrew Spence • Martin Spencer • Peter Stancliffe • Wendy Steele • Paul Stockbridge • Paul Thomas
• Emma Thomason • Bill Thorne • Mandy Turgoose • Pamela Turner • Lena Vägberg • Piet Van Rens
• Maria Vincent • Indira Walker • Neil Wayman • Gordon Whittle • Richard Wilford • Richard Wilkins •
Sam Williamson • Kevin Wilson • Christopher Woodage • Paul Wright • Jane Williams • Gareth Naylor •
Mark Girdwood • David Ling • Alan Mayo • Mukesh Patel • Rachel Mizzi • Nick Branch • Mark Sephton
• Leonor Arrebola • Hernal Patel • Emily Rumsey • Jennifer Watson • Catherine Kay • James Muller
• Daniel Pilkington • Peter Gannon • Joanne Lewis • Matthew Jaynes • Chris Miller • Gillian Morris •
Colin Newbould • John O’Neill • Graeme Perkins • Angela Hoskins • Jenni Newcombe • Vicky Baulch
• Jane Colman • Mark Dignum • Bruce Vernon • Trevor Clarke • Derrick Jones • Simon Tanner • Tim
Dickinson • Treena Edwards • Meriam Lindsay • Mark Hinton • Helen Brannan • Ruth Buchanan • Tony
Pinney • Dawn Harrison • Kate Krachai • Breda Quinn • Ronnie O’Connell • Stephen Davenport • Dru
Homer • Neil Smith • Ed Teece • Claire Pierce • Barbara O’Dwyer • Cecile Begat • Jordan Costello •
Trevor Watson • Robert Clayton • John Tognarelli • Philip Millward • Justin Ahern • Colin Chambers •
Kathryn Rooney • Amanda Race • Rachel Evans • Nigel Morton • Richard Brown • Shawn Murtough
• Ian Birch • Claire Montgomery • Giby George • Jonathan Dormer • David Jamieson • Stefan
For further information on module content,
Verstegen • Peter Kendrick • Chris Forrest • James Culyer • John Horry • Chris Hinds • Maria Adesida
to arrange a free gap analysis or to talk to
• Jack Beattie • Donna McKenna • Richard Brown • Stephen Clarke • Philip Davies • Nigel Chesterton
someone about the process and eligibility,
• Jonathan Bradshaw • Sarah Gardiner • Shaun Barford • David Thomson • Azhar Salahudeen •
please contact Stella Pearson-Smith, QP
Claire Trumper • Jason Morris
•
Phil
Cryan at
• Eurwyn
Roberts • Stephan Croft • Leen van de Water •
Administrator,
StellaPearsonSmith@nsf.org
Jacqueline Barry • David Franks • Hazel Pitt • Linden
Adam432
McLennan
• Laura Matthys • Jasbir
or call Stead
+44 (0)• 1751
999
Rattu • Attia Hasnain • Stephen Swan • Rachael Hill • Set Yong • Pauline Johnstone • Lee Heading •
Abdul Ghafoor • Maxine Shaw • Lana Morrison • Peter Mollison • Akbar Kulasi • Kate Smith • Philip
Rose • Paul Gomm • Helen O’Shea • Richard Gore • David Cross • Arthur Stevenson • Adam Elliott •
Clare Myatt • Robert Scott • Lynsey Niblett • Anne Moore • Caroline Gibbs • Tony James • Steve Evans
• Julia Hocking • Jill O’Mullane • David Harvey
2800 NSF PB A4 QPs14 Brochure folder OUTER.indd 1
Why
Choose