ISPE 2011 Tampa
Conference
Seminars
Latest Proven Solutions
in Aseptic Processing
Tampa, Florida, USA
21-24 February
What Does Quality
Risk Management Really Mean?
Your Data – A Risk-Based
Approach to Integrity
Regulatory Inspection –
Prepare for it Now
Syringe Processing
Workshop
Potent Compounds – A Risk-Based
Approach to Containment
Identify and Address Compliance
Risk Before FDA Inspection
Lower Production Cost Through
Effective Energy Use
Applying
Solutions
to Emerging
Training
Maintain and Control a
Contained Environment
Techniques for an Effective
Cleaning Validation Program
Develop and Validate
Bioprocesses
Industry Challenges
ENGINEERING PHARMACEUTICAL INNOVATION
www.ISPE.org/2011TampaConference
ISPE 2011 Tampa Conference At-A-Glance
Tampa Conference Offerings – Schedule-At-A-Glance
Table of Contents
Knowledge Elements Reference Chart
12-13
Registration Form
14
General Information
15
Table Top Exhibits and Sponsorships
15
Career Solutions
Visit the Career Solutions to see the latest
positions available from leading
pharmaceutical and biotechnology employers
and suppliers.
Employers/Recruiters - Take advantage of
special ISPE 2011 Tampa Conference pricing
on Job Board postings. Let some of the
most qualified pharmaceutical science and
manufacturing professionals come see you!
Visit www.ISPE.org/careers for more details.
New Member/First Time
Attendee Orientation
Monday
New Members and first time attendees are
cordially invited to this special networking
breakfast hosted by the Membership
Development Committee (MDC). Meet
fellow Society Members and Tampa
Conference attendees to foster new
relationships, learn how to make the most
out of your ISPE membership, and
to ask questions. Bring plenty of business
cards for networking.
2
Education
Training Course Descriptions
Tuesday,
22 February
Exhibits Open 17.00 – 18.30
4-11
Training
Conference Seminar Descriptions
Monday,
21 February
3
Exhibits Open 07.30 – 16.00
Wednesday,
23 February
Thursday,
24 February
Exhibits Open 07.30 – 16.00
Aseptic Processing of Sterile Products: Innovations, Regulatory
Guidance and Compliance in a Practical World (E01)
Syringe Processing Workshop (E05)
Quality Risk Management: Focused, Practical Application (E02)
Containment: A Risk-Based Approach (E06)
Data Integrity: How to Verify, Validate, and Maintain (E03)
Pharmaceutical Inspections and Compliance:
Current FDA Enforcement Trends (E07)
Inspection Readiness Workshop: From Site Preparation to
Successful Execution (E04)
Energy Saving Projects - Case Studies and
Tools for Saving Energy (E08)
Cleaning Validation Principles (T17)
Containment Fundamentals (T16)
Process Validation in Biotechnology
Manufacturing (T32)
Opening Reception in Exhibit
Hall
17.00 - 18.30
Networking Reception 17.00
- 18.30
Certified Pharmaceutical Industry
ProfessionalTM (CPIPTM) Workshops
Introduction Workshops - Monday and Wednesday, 08.00 - 09.00
These complimentary, one hour workshops provide an overview of the CPIPTM — a
pharmaceutical industry focused, international, competency-based credential made
available through the ISPE Professional Certification Commission. Topics include:
CPIPTM introduction, eligibility criteria, and the application and examination process.
www.ISPE-PCC.org
How-to Workshops - Tuesday and Thursday, 08.00 - 09.00
These complimentary, one hour workshops explain how to submit an eligibility
application and prepare for the examination. Topics include: obtaining a university
transcript, completing the professional experience forms, using the CPIPTM Study Guide,
and organizing study groups. www.ISPE-PCC.org
Some courses include a pre-recorded Webinar reviewing basic information so you can maximize
your learning experience during the course. Access information will be provided via email one
week prior to the start of the event.
Applying Solutions to Emerging Industry Challenges
21-24 February 2011 • Grand Hyatt Tampa Bay • Tampa, Florida, USA
Knowledge Elements Reference Chart
1
2
Technical Knowledge
Competency Areas
3
4
5
Product Development
Facilities and Equipment
A
B
C
A
B
C
D
Formulation, clinical phases, and manufacture
A
B
C
A
B
C
A
B
A
B
Materials management
Technology transfer
Production scale-up and optimization
Design and construction/installation
Commissioning and qualification as a risk management strategy
Operation and maintenance
Controls and automation
Information Systems
Supply Chain Management
Production Systems
6
Regulatory Compliance (Drugs, Env.,
Health, and Safety)
7
Quality Systems
Tampa Conference Seminars or
Training Courses
Operational economics
Warehouse and distribution management
Production unit operations - drug (small molecule) and biologics
Production management
Production control
Government regulations
Standards, practices, and guides
Risk management and Quality Management System (QMS)
Systems validation
Technical Knowledge Competency Areas
1
2
3
4
5
6
7
A B C A B C D
A B C A B C A B A B
Aseptic Processing of Sterile Products: Innovations, Regulatory
Guidance and Compliance in a Practical World (E01)
X
Quality Risk Management: Focused, Practical Application (E02)
X
X
X
X
X
X
Data Integrity: How to Verify, Validate, and Maintain (E03)
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Inspection Readiness Workshop: From Site Preparation to Successful
Execution (E04)
Syringe Processing Workshop (E05)
X
X
X
X
X
Containment: A Risk-Based Approach (E06)
X
X
X
X
X
X
Pharmaceutical Inspections and Compliance: Current FDA Enforcement
Trends (E07)
Energy Saving Projects - Case Studies and Tools for Saving Energy
(E08)
Cleaning Validation Principles (T17)
X
X
X
X
X
X
X
X
X
X
X
All Tampa Conference seminars (and one training course) contain knowledge related to the seven technical knowledge
competency areas for the CPIPTM certification program, an international credential made available through the ISPE
Professional Certification Commission. Completion of any of these seminars does not guarantee successful completion
of the certification exam. Visit www.ISPE-PCC.org for details.
Applying Solutions to Emerging Industry Challenges
21-24 February 2011 • Grand Hyatt Tampa Bay • Tampa, Florida, USA
3
Latest Proven Solutions in Aseptic Processing
Aseptic Processing
of Sterile Products:
Innovations, Regulatory
Guidance and Compliance
in a Practical World (E01)
Planned and Implemented by the ISPE Sterile Products Processing
Community of Practice (COP)
Seminar Content Level
Fundamental • Intermediate • Advanced
Attend this two-day seminar to learn about the latest
commercially proven solutions in aseptic processing which
you can apply.
• Get updates on hot regulatory topics
• Learn from experts working in similar environments to
yours
• Participate in in-depth case study presentations and
discussions
• Network with attendees and presenters
Topics will cover a range of technologies for sterile products,
from compounding to inspection and include:
• Sterile filtration
• New filling equipment
• Contract manufacturing capabilities
• Lyophilization technology challenges
• Visual inspection technologies
• Recent warning letters / regulatory updates
• Case studies
This session will also feature the new ISPE Baseline Guide:
Sterile Manufacturing Facilities.*
*Anticipated release date Q1 2011. Date is subject to change.
This seminar is priced to include an electronic copy of the
guide.
4
Leaders
• Ryan Hawkins, Manufacturing Manager, Cook Pharmica, USA
• Manmohan Sihra, Sihra Consulting, Sterile Products Process Consulting, USA
How You Will Benefit
At the conclusion of this session, participants will be able to:
• Describe what is happening in the world of sterile technologies
• Evaluate warning letter implications for their business
• Apply learning from others through case study
• Explain recent regulatory trends
• Expand your industry network
Speakers
• Allan Ader, Vice President, SafeBridge Consultants, Inc., USA
• James Akers, PhD, President, Akers Kennedy and Associates Inc., USA
• Jonathan Lind, Distinguished Project Engineer, Roche Colorado Corp., USA
• Jack Lysfjord, Principal Consultant, Lysfjord Consulting LLC, USA
• Jerold Martin, Senior VP, Global Scientific Affairs, Biopharma, Pall Corp., Life Sciences
Div., USA
• Michael Miller, PhD, President, Microbiology Consultants, LLC., USA
• Michael de la Montaigne, President, Eisai Machinery USA Inc., USA
• Anthony Pavell, Senior Manager of Validation and Process Improvement, APP Pharma,
USA
• Ernesto Renzi, Vice President, IMA Life North America Inc., USA
• Kristy A. Zielny, Biologist, FDA, Invited
Who Should Attend
Professionals from engineering, operations, quality, planning
and project management
Community of Practice (COP)
Sterile Products Processing
Related Guidance Documents, Articles, and Publications
• NEW- ISPE Baseline® Guide: Sterile Manufacturing Facilities*
• Recent Warning Letters
Visit www.ISPE.org/Publications for more information
For more information visit www.ISPE.org/2011TampaConference
Applying Solutions to Emerging Industry Challenges
21-24 February 2011 • Grand Hyatt Tampa Bay • Tampa, Florida, USA
21 – 22 February
1.2 CEU
What Does Quality Risk Management
Really Mean?
Quality Risk Management:
Focused, Practical
Application (E02)
Planned and Implemented by the ISPE C&Q and PM
Community of Practice (COP) and PQLI
Seminar Content Level
Fundamental • Intermediate • Advanced
Right now the pharma industry needs quality risk
management (QRM) advice that is focused, tried and proven
useful, to save time, effort, and ultimately cost. Overcome
reticence in applying QRM. Learn how to document it
effectively within your company culture and embed it into
everyone’s understanding. This highly-interactive two-day
seminar will include discussions, real-life case studies, and
the opportunity to practice a variety of techniques. Five
years down the road from the implementation of ICH Q9,
many companies have developed their systems for quality
risk management, while some are still working through the
process. This is an opportunity for practitioners to share
experiences and swap ideas. It is also an opportunity for the
less-experienced to try out some tools and techniques.
21 – 22 February
1.2 CEU
Leaders
• David Dolgin, Senior Quality Program Manager, Abbott Labs, USA
• John Hannon, Principal, Computer Systems, Commissioning Agents, Inc., USA
How You Will Benefit
At the conclusion of this session, participants will be able to:
• Build and implement a QRM strategy
• Understand how company culture is an inherent consideration in finding the best
possible ways to incorporate QRM effectively
• Apply tools and techniques and use documentation to educate various teams and
management levels to the QRM approach
• Explain how to document QRM to ensure its effectiveness
• Explain how everyone should be included in QRM planning and implementation
• Adapt QRM applications that have worked for others
Speakers
• Keith Gibbs, Corporate Manager, C&Q, Yonkers Industries, USA
• Timothy Howard, CPIP, PE, Director, Commissioning / Validation,
Commissioning Agents, Inc. USA
• James Lambert, Director, Quality Engineering, Genentech, USA
Who Should Attend
The entire pharmaceutical community
Communities of Practice (COP)
C&Q and Project Management
For more information visit
www.ISPE.org/2011TampaConference
Applying Solutions to Emerging Industry Challenges
21-24 February 2011 • Grand Hyatt Tampa Bay • Tampa, Florida, USA
5
Your Data – A Risk-Based Approach to Integrity
Data Integrity: How to
Verify, Validate, and
Maintain (E03)
Planned and Implemented by the ISPE GAMP
Community of Practice (COP)
Seminar Content Level
Fundamental • Intermediate • Advanced
Data Integrity is the assurance that your data is consistent,
correct, accessible and secure. This seminar will provide
implementation examples which utilize GAMP methodology
in the design, testing, and implementation of different
data warehouse repositories. Data warehousing becomes
necessary to meet an organization’s need for reliable,
consolidated, unique and integrated reporting and analysis
of its data, at different levels of aggregation. Additionally,
cloud computing is gaining momentum in the pharmaceutical
industry. Learn from colleagues who have implemented
successful cloud technology infrastructure utilizing a riskbased approach.
Leaders
• Michael Osburn, Associate Senior Quality Consultant, Eli
Lilly & Co., USA
• Judith Samardelis, Associate Director, Computer and
Systems Validation, QIAGEN, Inc., USA
• Lorrie Vuolo-Schuessler, Manager, GlaxoSmithKline, USA
How You Will Benefit
At the conclusion of this session, participants will be able to:
• Understand the lifecycle management process for data
• Effectively manage and maintain data as its associated risks
• Distinguish between data integrity and data validity
• Determine what to test
• Analyze what is data and database Integrity testing
• Determine validity of a generated piece of data
• Analyze risks and challenges associated with external service providers
Speakers
• Winnie Cappucci, PS Compliance IT Sys NA, Bayer Healthcare, USA
• Stephen Ferrell CISA, Director, Software QA, Meso Scale Diagnostics,
LLC, USA
• Marc Monette, Senior Manager, Allergan, USA
• Anita Morrison, Computer Systems QA Manager, Eli Lilly & Co., USA
• Mark Newton, Consultant-QA, Eli Lilly and Company, USA
• George Serafin, Director, Deloitte & Touche LLP, USA
• George Smith, Compliance Officer, DHHS, FDA, CDER, OC, USA, Invited
• Ivan Soto, Senior Validation Manager, Amgen Inc., USA
• Eric Staib, Director, IT Quality – CSV, Covance, USA
• Jason Tepfenhardt, Vice President, Life Sciences, Genilogix, USA
• Sion Wyn, Director, Conformity Ltd., UK
Who Should Attend
IT, IT Quality, QA, GAMP, Lab Analysts
Community of Practice (COP)
GAMP
Related Guidance Documents, Articles, and Publications
• GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems
• GAMP® Good Practice Guide: A Risk-Based Approach to Operation of GxP
Computerized Systems
Visit www.ISPE.org/Publications for more information
For more information visit
www.ISPE.org/2011TampaConference
6
Applying Solutions to Emerging Industry Challenges
21-24 February 2011 • Grand Hyatt Tampa Bay • Tampa, Florida, USA
21 – 22 February
1.2 CEU
Regulatory Inspection – Prepare for it Now
Inspection Readiness
Workshop: From Site
Preparation to Successful
Execution (E04)
Seminar Content Level
Fundamental • Intermediate • Advanced
Would you know what to do if a regulator or notified group
showed up at your door? This two-day workshop gives you
tools to prepare your organization for a regulatory
inspection, and a chance to practice these skills in a safe and
mentoring environment. We have all heard the adage “fail to
plan, plan to fail,” and in no area is this more relevant than
inspection readiness. This two-day, interactive workshop will
prepare you to plan for inspections accurately and execute
them effectively by knowing what to expect and how to best
respond.
Topics include:
•U
nderstanding purpose of inspection and your
regulatory filing
• Conducting a Quality Systems Gap Assessment for
inspection preparation
• Inspection logistics and site preparations
• Preparing computer and automated systems for
regulatory review
• Special considerations for laboratories and process
equipment
• Utilizing inspection results for competitive advantage
• Interview techniques: how to conduct a site tour and how
to give a software demonstration
21 – 22 February
1.2 CEU
Leaders
• Janet Bowen, Principal Consultant, Commissioning Agents PR International,
USA
• Philip Russ, Owner and Principal Consultant, Innovative Consultants GXP, USA
• Kimberly Snyder, Senior Technical Manager, Genentech, USA
• Rebecca Waterbury, ChE, JD, Regulatory Compliance International, Abbott
Vascular, Belgium
How You Will Benefit
• Comprehensively understand a site inspection readiness program
• Describe regulatory authorities’ audit processes and the purpose of an
inspection
• Utilize the tools needed to accomplish tasks related to inspection readiness
• Describe specific roles and responsibilities during an audit
• Understand the inspection intricacies associated with laboratories and process
equipment
• Establish yourself as an expert in your functional area
• Formulate effective responses to various types of questioning used by the FDA
and other regulators
• Guide auditors to focus on your quality system’s strengths instead of
weaknesses
Who Should Attend
Professionals from quality assurance, quality control, engineering, regulatory
compliance, quality systems, validation, IT, laboratory, as well as manufacturing
supervisors, and area leaders/managers
For more information visit
www.ISPE.org/2011TampaConference
Applying Solutions to Emerging Industry Challenges
21-24 February 2011 • Grand Hyatt Tampa Bay • Tampa, Florida, USA
7
Syringe Processing Workshop
Syringe Processing
Workshop, 2nd Annual (E05)
Planned and Implemented by the ISPE Sterile Products Processing
Community of Practice (COP)
Seminar Content Level
Fundamental • Intermediate • Advanced
This second annual syringe workshop will present new case
studies, technology, and innovative ideas in clinical operations,
high volume pharmaceuticals and biologicals for existing or
new operations. International in scope, new and challenging
operations around the globe will be presented. Topics will
cover all aspects of prefilled syringes from process and product
development, packaging component issues, quality assurance
considerations, and inspection hot topics. An interactive workshop
will challenge participants to learn by doing, asking questions and
solving problems, thus taking advantage of speakers’ and fellow
participants expertise and experience.
Past Attendee Comments: “It was new, there were great case
studies, and the working group session was wonderful!!” said
a 2010 attendee. There was “very little overlap of topics,” and
the program was, “very applicable and one of the most effective
seminars I have been a part of. Audience was very, very attentive
and interested.” Attend this seminar where ISPE presents
education in a non-commercial atmosphere for knowledge sharing.
Topics include:Syringe Breakage, Container Closure Integrity,
Packaging, Decontamination Methods, Auto Injector: design,
integration, assembly, Case Study Implementation of New
Lines, Clinical Operations, and Outsourcing
Leaders/Program Committee
• Nancy St. Laurent, CPP, Senior Supervisor Process
Engineering, Parsons, USA
• Joerg Zimmermann, Director of Production, Vetter,
GERMANY
• Patrick Begley, Manager Technical Services, Becton
Dickinson and Company, USA
• Bill Friedheim, Sales Manager, Skan US Inc., USA
8
How You Will Benefit
At the conclusion of this session, participants will be able to:
• Analyze technologies to improve syringe operations
• Effectively manage risk
• Solve manufacturing challenges
• Implement effective commissioning and qualification practices
• Strengthen supply chain security with newly available technologies
Speakers to Date
•E
rnest Bancroft, Sales Manager- East, Korber Medipak, USA
• John Finkbohner, PhD, RAC, Director, Regulatory Affairs / Investigational Vaccines,
MedImmune, USA
• Brant Bulgarelli, Associate Director, Parental Manufacturing, Clinical Supply
Operations, Bristol Myers Squibb Company, USA
• Gerald Burkle, Director Pharmaceutical Production, Vetter Pharma-Fertigung
GmbH+Co.KG, GERMANY
• Allison Cacciatore, Deputy Director, Equipment Engineering, Sanofi Pasteur, USA
• Robert Gervais, National Sales Director, Harro Hofliger Packaging Systems,
Inc., USA
•K
aren Hirshfield, RPh, Director Regulatory, FDA, Invited
• David Machak, Senior Scientist, American Glass Research, a Division of AGR
International, Inc., USA
• J errod Shook, Principal Engineer, Novartis Vaccines & Diagnostics Inc, USA
• Sharon Wu, PhD, Principal Scientist, Drug Product & Device Development,
Process Development, Amgen Inc., USA
Who Should Attend
Process development engineers, pharmaceutical product developers, primary
packaging specialists, production managers, quality assurance managers, filling
equipment suppliers, primary component suppliers, filling supervisors, generic
pharma/bio manufacturers
Communities of Practice (COP)
Sterile Products Processing, Biotechnology, Commissioning and Qualification,
Investigational Products, and Process and Product Development
For more information visit
www.ISPE.org/2011TampaConference
Applying Solutions to Emerging Industry Challenges
21-24 February 2011 • Grand Hyatt Tampa Bay • Tampa, Florida, USA
23 – 24 February
1.2 CEU
Potent Compounds – A Risk-Based Approach
to Containment
Containment: A Risk-Based
Approach (E06)
(2 CM Points Applied for Industrial Hygienists)
Planned and Implemented by the ISPE Containment Community of
Practice (COP)
Seminar Content Level
Fundamental • Intermediate • Advanced
Examine the latest scientific, risk-based approaches to the
containment of potent compounds. Is it an idealistic concept?
Maybe; maybe not. Join a discussion evaluating containment
systems and approaches specifically for potent and highly
hazardous compounds. What happens when the design/
approach does not work? How do you overcome risk of
failure? The FDA will be invited to speak on how science and
risk-based approaches to containment are viewed. You will
also hear directly from companies and subject matter experts
who have successfully implemented scientific, risk-based
approaches, speakers who are innovators on assessing
Contract Manufacturing Organizations (CMOs), those who have
successfully communicated containment strategies and from
CMOs who have implemented them. Learn how to use Industrial
Hygiene (IH) data to support assessments.
With an increasing focus on containment for pharmaceutical
manufacturing, active pharmaceutical ingredients (APIs) are
becoming more targeted, hence more potent and more prolific.
Environmental, health and safety (EHS) pressures push for the
use of engineering controls, but the implementation of RABS
and isolation technology may be an ideal solution for some
pharmaceutical manufacturers, but may not be the most efficient
processing option, nor most cost effective solution for others. A
risk-based approach to containment offers some alternatives.
Leaders
• Alan George, Product Manager, ILC Dover Inc., USA
• Kimberly Ray, Manager of Project Management,
Oso Biopharmaceuticals Mfg LLC, USA
23 – 24 February
1.2 CEU
How You Will Benefit
At the conclusion of this session, participants will be able to:
• Recognize that different types of toxicology limits are set for worker, product,
and environmental protection
• Recognize or describe the following containment concepts: Contain at the
source; Containment challenge; Material migration; and Risk
•Identify containment technologies and their position in the containment hierarchy
• Recognize applications of hierarchy of containment solutions to real-world
containment challenges
• Describe how other industry professionals solved containment challenges
• Understand new technologies available and how they impact containment
and cross-contamination
Speakers
• Beth Brock, PE, Consultant Engineer, Eli Lilly & Co., USA
• Jonathan Lind, Distinguished Project Engineer, Roche Colorado Corp., USA
• Mr. Edwin Melendez, Consumer Safety Officer, FDA/DMPQ, USA, Invited
• George Petroka, CIH, CSP, RBP, Director, BioPharma/EHS Services, IES
Engineers, USA
• Gabriel Salmon, Technical Services Manager, Catalent Pharma Solutions, USA
• Robert Sussman, PhD, Managing Principal, SafeBridge Consultants, Inc., USA
• Hugh Varner, PhD, Director Tech Transfer, CANGENE BioPharma, USA
• James Wood, PE, Senior Assoc. Consultant Engineer, Eli Lilly & Co., USA
Who Should Attend
Engineers, EH&S, Project Managers, Product Managers, Production Managers
and Specialists, Technical Operations, Maintenance, Purchasers of containment
equipment, Quality Managers and Specialists, Toxicologists
Community of Practice (COP)
Containment
Related Guidance Documents, Articles, and Publications
• ISPE Baseline® Guide Volume 7: Risk-Based Manufacture of Pharmaceutical
Products (Risk-MaPP)
• ISPE Knowledge Brief: Risk-Based Approaches to Cross Contamination
Visit www.ISPE.org/Publications for more information
For more information visit
www.ISPE.org/2011TampaConference
Applying Solutions to Emerging Industry Challenges
21-24 February 2011 • Grand Hyatt Tampa Bay • Tampa, Florida, USA
9
Identify and Address Compliance Risk
Before FDA Inspection
Pharmaceutical Inspections
and Compliance: Current
FDA Enforcement Trends
(E07)
Seminar Content Level
Fundamental • Intermediate • Advanced
This two-day seminar will bring together FDA and industry
experts to address:
(1) Current inspection findings
(2) FDA expectations for GMP and quality systems
(3) The quality of the supply chain by adequate qualification
of vendors and contract manufacturers
(4) Current expectations around management responsibility
(5) CDER’s Part 11 inspectional assignments
New GMP initiatives include:
• Q10 and process validation
• Continuous manufacturing including PAT
• Identifying leading problem indicators and examples of
successful solutions with respect to a Quality Systems
(QS) approach
• Proactive QS elements (rather than defensive ones) in
GMP and Quality Systems
• Examples from Q8, Q9, and Q10.
How You Will Benefit
At the conclusion of this session, participants will be able to:
• Analyze your company’s current readiness for FDA inspections in light of very recent
indicators and current inspection findings
•U
nderstand current findings as to the role and responsibility of senior management
•U
nderstand your company’s compliance risk and address it proactively
• Apply solutions from other company’s successful approaches
• B etter understand CDER’s next steps in continuing its Part 11 assessment
Speakers
• Brian Belz, Consumer Safety Officer, FDA, Invited
• Sion Wyn, Director, Conformity Ltd., UK
Who Should Attend
Manufacturing, Development, Engineering, Laboratory, Regulatory, Quality, IT
Communities of Practice (COP)
C&Q, GAMP, Good Control Laboratory Practices, PAT
Related Guidance Documents, Articles, and Publications
• Part 11
• Guidance documents such as Q8, 9, 10, and Process Validate Guidance
Document Draft
Visit www.ISPE.org/Publications for more information
For more information visit
www.ISPE.org/2011TampaConference
Leaders
• Francis Godwin, Compliance Officer, FDA
• Timothy Tyson, Chairman and CEO, Aptuit, Inc., USA
10
Applying Solutions to Emerging Industry Challenges
21-24 February 2011 • Grand Hyatt Tampa Bay • Tampa, Florida, USA
23 – 24 February
1.2 CEU
Lower Production Cost Through
Effective Energy Use
Energy Saving Projects –
Case Studies and Tools
for Saving Energy (E08)
Planned and Implemented by the ISPE Sustainable Facilities
Community of Practice (COP)
Seminar Content Level
Fundamental • Intermediate • Advanced
Saving energy is the most direct route to improving your
company’s bottom line. Understanding where and how to
approach these projects can improve the projects outcome.
In this two-day seminar, we will discuss four case studies
of energy improvement projects that have decreased the
amount of utilities consumed resulting in lower production
cost and increased energy intensity.
Topics addressed include:
• Water
• Steam
• HVAC
• Electricity
• Process efficiency
• Funding
• Rebates
Tools, resources and rebates available will be presented in
workshop fashion to you to help you decide which projects
best fit your needs.
23 – 24 February
1.2 CEU
Leaders
• John Postiglione, Manager Energy Programs, Spirax Sarco Inc., USA
• Michael Denault, Principal, Denault Associates, USA
How You Will Benefit
At the conclusion of this session, participants will be able to:
• Identify the fundamental components of a comprehensive GEP and an
effective maintenance program
• Understand the importance of GEP as an essential foundation to an effective
manufacturing operation
• Analyze and understand the benefits and challenges associated with
maintenance programs
• Interpret and understand how to utilize the GEP and Maintenance
Good Practice Guides to develop or improve engineering and maintenance
program activities in your own organization
• Deliberate on the current trends associated with GEP and maintenance
activities
Who Should Attend
Maintenance managers, project managers, sustainability managers, plant
managers, project engineers
Communities of Practice (COP)
Critical Utilities, HVAC, Project Management and Sustainable Facilities
Related Guidance Documents, Articles and Publications
• ISPE Good Practice Guide: Good Engineering Practice (GEP)
• ISPE Good Practice Guide: Maintenance
Visit www.ISPE.org/Publications for more information
For more information visit
www.ISPE.org/2011TampaConference
Applying Solutions to Emerging Industry Challenges 11
21-24 February 2011 • Grand Hyatt Tampa Bay • Tampa, Florida, USA
Maintain and Control a Contained Environment
Containment Fundamentals (T16)
Training Course Level
Fundamental • Intermediate • Advanced
21 – 22 February
1.3 CEU
Instructor
• Brian G. Ward, Ph.D., CSci, CChem, CIH (Ret), FRSC, Retired,
Containment Engineering Technology Center of Eli Lilly, USA
Community of Practice (COP)
Containment
Take Back To Your Job
In today’s world of advanced medications, potent compounds are
playing an increasingly prominent role in fighting illness and disease.
While benefits to patients are great, the potential adverse effects to
healthy individuals working with these compounds are numerous. Just
as important, quality organizations within companies are embracing
good manufacturing practices (GMPs) for satisfactory containment
of processes on the production floor, thus reducing or eliminating the
potential for cross-contamination. Other project goals are the business
and environmental benefits related to reducing production costs, and
limiting the impact to the outdoor environment.
This course will focus on airborne contaminants and begin by
discussing the definition, history, and rationale for the containment of
compounds and processes. An exploration of different containment
philosophies, methods of source containment, and a hierarchy of
containment approaches will also be covered. After establishing the
need for containment and presenting alternative methods, the course
will focus on the importance of fully understanding a manufacturing
process in all its dimensions (physical hardware, remedial containment
provisions, facility considerations, operator interface, cleaning and
decontamination, and other aspects) before optimal containment
solutions may be incorporated. This course will address plant
operations ranging from pilot scale to commercial manufacturing.
The general principles and approaches presented in the course
will be compatible with the new containment chapter of ISPE’s
Active Pharmaceutical Ingredients Baseline® Guide. Principles and
approaches presented will be applicable to both bulk and secondary
pharmaceutical manufacturing operations. Participants can expect open
class discussions, sample problems, and an analysis of case studies.
At the conclusion of this training course, participants will be able to:
• Define key terminology used when discussing containment
• Identify rationales for effective containment
• Discuss the difficulty of preventing substances from being distributed
throughout the environment
• Cite a hierarchy of containment approaches
• Understand fundamental containment technologies
• Explain the importance of understanding a process before applying
containment principles
• Describe principles for maintaining and controlling a contained environment
• Discuss methods for evaluation of containment performance, including
ISPE’s Good Practice Guide on Assessing the Particulate Containment
Performance of Pharmaceutical Equipment
Who Should Attend
•Professionals who need knowledge of fundamental containment
principles, such as facilities and process development engineers,
regulatory compliance and quality assurance specialists, safety and
industrial hygiene personnel, and operations and manufacturing
managers
• Engineering professionals and other consultants who work with the
pharmaceutical industry
Related Guidance Documents, Articles and Publications
• ISPE Baseline® Guide: Active Pharmaceutical Ingredients
• ISPE Good Practice Guide: Assessing the Particulate Containment
Performance of Pharmaceutical Equipment
• ISPE Baseline® Guide Volume 7: Risk-Based Manufacture of
Pharmaceutical Products (Risk-MaPP)
Visit www.ISPE.org/Publications for more information
To register visit
www.ISPE.org/2011TampaConference
Techniques for an Effective Cleaning
Validation Program
Cleaning Validation Principles (T17)
Training Course Level
Fundamental • Intermediate • Advanced
As cleaning technology and detection methodology advance, so
do the challenges associated with establishing, managing, and
maintaining a scientifically sound cleaning validation program.
FDA’s risk-based regulatory initiatives focus new attention on the
risks of cross-contamination. The solution is to understand life
cycle management techniques for an effective cleaning validation
program.
12
Applying Solutions to Emerging Industry Challenges
21-24 February 2011 • Grand Hyatt Tampa Bay • Tampa, Florida, USA
21 – 22 February
1.3 CEU
This course will cover elements of a cleaning validation program from start
to finish, exploring such concepts as the determination of residues to be
targeted, selection of analytical and sampling methods, determination of
appropriate limits in various pharmaceutical and biotechnology processes,
and establishment of scientific rationales acceptable to regulatory
inspectors. For mature cleaning validation programs, concepts such as
understanding process control, capability, learning to effectively selfaudit a cleaning validation program, and documentation will be essential
takeaways.
Instructor
• Rebecca Brewer, Director, Validation & GMP Compliance, Dober Group
Cleaning Validation Principles cont.
Community of Practice (COP)
Process/Product Development
Take Back To Your Job
At the conclusion of this course, participants will be able to:
• Identify and characterize potential residues including product,
processing aids, cleaning agents, and adventitious agents
• Determine suitable sampling techniques and the selection of
sampling locations that present a challenge for the cleaning process
• Calculate residue limits that meet all necessary regulatory
requirements
• Create scientifically sound rationales, validation protocols, and
reports
• Manage the challenges of multi-product facilities in the
establishment of limits, determination of validation strategies, and
maintaining the validated state
• Understand campaign-based production strategies for effective and
scientifically sound validation
• Differentiate the requirements for cleaning validation when using
manual,
semi-automatic, and automatic cleaning technologies
• Comprehend the pitfalls inherent in cleaning after the production of
biopharmaceutical and pharmaceutical products
• Accomplish analytical method validation and recovery study requirements
in cost-effective studies that provide the necessary assurance of an
analytical system
• Evaluate cleaning practices, limit calculations, scientific rationales, and
validation documents through internal self-audits to ensure
compliance with ever-changing regulatory needs
• Practice hands-on exercises designed to reinforce core competencies and
job-focused skills
Who Should Attend
• Quality assurance specialists, quality control technicians, regulatory
affairs professionals, pharmacologists and toxicologists, validation
scientists, and validation service personnel
• Manufacturing supervisors, technical support personnel, and engineers
responsible for evaluating cleaning systems, reviewing equipment, and
supporting the cleaning validation program on the plant floor
• All levels of management who need to understand the science of
cleaning and cleaning validation including the aspects of residue
selection, sampling method and analytical detection method validation,
limits determination, and strategies for managing multi-product facilities
To register visit
www.ISPE.org/2011TampaConference
Develop and Validate Bioprocesses
Process Validation in
Biotechnology Manufacturing
(T32)
Training Course Level
Fundamental • Intermediate • Advanced
The inherent complexity and uncertainty of biotechnology makes
developing and validating bioprocesses for manufacturing proteins and
biopharmaceuticals very difficult. Understanding and using FDA’s new
Process Validation Guideline is critical to establishing and maintaining control
of complex processes, as well as achieving regulatory approval of new
products.This course is designed to provide a clear understanding of the
regulatory, scientific, and engineering tools required to successfully develop
and validate bioprocesses. In addition, the course identifies the long list of
activities required to validate biopharmaceutical processes. Topics include
a comprehensive strategy to process validation; a review of important
biotechnology manufacturing processes, and the regulatory requirements
for their validation. In addition to classroom lectures, participants will take
part in several interactive exercises, solve group problems, and participate
in class discussions to understand the underlying principles behind Process
Validation.
This is an advanced course. Participants should have a basic understanding
of commissioning, qualification and validation and basic familiarity with
biotechnology manufacturing processes and unit operations.
23 – 24 February
1.5 CEU
Instructor
• Mark Witcher, PhD, Retired, Pro Re Nata, Inc.
Communities of Practice (COP)
Biotechnology and Process/Product Development
Take Back To Your Job
At the conclusion of this course, participants will be able to:
• Develop and execute validation master plans and validation protocols
• Understand and use FDA’s current process validation guidelines
• Successfully run conformance lots for process qualification
• Define key validation activities for biopharmaceutical process
development and manufacturing
• Apply strategies and fundamental approaches for process validation of
upstream and downstream processes for clinical and commercial
manufacturing
• Discuss validation documentation requirements
Who Should Attend
• Process development engineers, validation personnel, manufacturing
supervisors and managers, quality assurance specialists, and
management personnel.
• Senior manufacturing and engineering managers who want to
understand the regulatory and scientific requirements associated with
process validation.
• Other professionals with commissioning, qualification, and validation
responsibilities who need an understanding of process validation for
biotechnology manufacturing.
To register visit
www.ISPE.org/2011TampaConference
Applying Solutions to Emerging Industry Challenges 13
21-24 February 2011 • Grand Hyatt Tampa Bay • Tampa, Florida, USA
ONLINE: www.ISPE.org/2011TampaConference FAX: +1-813-264-2816
MAIL: ISPE, 3109 W. Dr. Martin Luther King Jr. Blvd., Suite 250, Tampa,
Florida, 33607 USA
ISPE 2011 Tampa Conference
Registration Form • 21-24 February 2011
ISPE ID # ________________________________
Please type or print clearly.
Check here
if you were previously an ISPE Member.
Please use code TP1 when registering for this event.
First Name___________________________________________________MI_ _________ Last Name_ ______________________________________________________________
Informal Badge Name_______________________________________________________ Chapter/Affiliate_ _________________________________________________________
Job Title _________________________________________________________________ Email Address __________________________________________________________
Company________________________________________________________________________________________________________________________________________
Business Address _________________________________________________________________________________________________________________________________
City_ __________________________________________State/Province__________________ Zip+4/Postcode_____________________ Country ___________________________
Business Tel_ _____________________________________________________________ Business Fax_ ___________________________________________________________
Emergency Phone For Last Minute Meeting Updates: Cell Phone ______________________________________ or Home Phone ______________________________________
I wish to keep my data confidential and it is given only for use by ISPE and its local Chapters and Affiliates.
First Time Attendee New Member
I do not wish my information to be printed in the Membership Directory or on Conference Attendee Listings.
New Member/First Time Attendee Orientation
HOTEL: Hotel accommodations and hotel fees are separate from Conference registration fees. For room reservations at the Conference venue, Grand Hyatt Tampa Bay, call
tel: +1-888-421-1442 or +1-402-592-6464 When making your reservation by phone, mention ISPE for a discounted rate of $229 single/double. This rate is good until 31 January 2011,
or until the room block is full, whichever comes first. Please contact the hotel as early as possible to make your reservations to ensure you are in the headquarters hotel.
Special Lunch Requirement —
Vegetarian
Kosher
Gluten Free
Payment Method — Registrations REquire payment attached
Substituting for ______________________________________________________________________________
(Nonmembers substituting for a member must pay the difference in fees)
Check enclosed payable to ISPE # __________________ in the amount of $ ________________
(Must be drawn on a US bank)
Bill credit card (circle type): VISA
MC
AMEX Card number _____________________________________
Exp. date _______ Name of cardholder_________________________________________ (As it appears on card)
Cardholder signature _________________________________________________________________________
Individual Seminar RegiSTration
Regular/Onsite (After 24 January)
Aseptic Processing
$ 1,175
$ 1,390
Nonmember
Committee
$ 1,455
$ 640
Member
New Member*
$ 1,475
$ 1,690
Nonmember
Committee
$ 1,770
$ 640
$
E02
Quality Risk Management
Member
New Member*
$ 1,075
$ 1,290
Nonmember
Committee
$ 1,355
$ 540
Member
New Member*
$ 1,375
$ 1,590
Nonmember
Committee
$ 1,670
$ 540
$
E03
Data Integrity
Member
New Member*
$ 1,075
$ 1,290
Nonmember
Committee
$ 1,355
$ 540
Member
New Member*
$ 1,375
$ 1,590
Nonmember
Committee
$ 1,670
$ 540
$
E04
Inspection Readiness
CANCELLED
Member
New Member*
$ 1,075
$ 1,290
Nonmember
Committee
$ 1,355
$ 540
Member
New Member*
$ 1,375
$ 1,590
Nonmember
Committee
$ 1,670
$ 540
$
E05
Syringe Processing
Workshop
Member
New Member*
$ 1,075
$ 1,290
Nonmember
Committee
$ 1,355
$ 540
Member
New Member*
$ 1,375
$ 1,590
Nonmember
Committee
$ 1,670
$ 540
$
E06 Containment:
A Risk-Based Approach
Member
New Member*
$ 1,075
$ 1,290
Nonmember
Committee
$ 1,355
$ 540
Member
New Member*
$ 1,375
$ 1,590
Nonmember
Committee
$ 1,670
$ 540
$
E07 FDA Pharmaceutical
Inspections
Member
New Member*
$ 1,075
$ 1,290
Nonmember
Committee
$ 1,355
$ 540
Member
New Member*
$ 1,375
$ 1,590
Nonmember
Committee
$ 1,670
$ 540
$
E08 Energy Saving Projects
Member
New Member*
$ 1,075
$ 1,290
Nonmember
Committee
$ 1,355
$ 540
Member
New Member*
$ 1,375
$ 1,590
Nonmember
Committee
$ 1,670
$ 540
$
(Price includes the New ISPE Baseline
Guide: Sterile Manufacturing)
n I elect ISPE membership.
New Member fee includes a one-year membership, a $239 value.
*To activate your membership please download a membership application at www.ISPE.org/membership
and return it to ISPE with this conference registration form. Membership is non-transferable. This is a 30-day
limited offer from time of conference end date.
TRAINING COURSE REGISTRATION
TOTAL
T17 Cleaning Validation Principles
Member
New Member*
$ 1,410
$ 1,625
Nonmember
$ 1,705
Member
New Member*
$ 1,710
$ 1,925
Nonmember
$ 2,020
$
T16 Containment Fundamentals
CANCELLED
Member
New Member*
$ 1,410
$ 1,625
Nonmember
$ 1,705
Member
New Member*
$ 1,710
$ 1,925
Nonmember
$ 2,020
$
T32 Process Validation in
Member
New Member*
$ 1,510
$ 1,725
Nonmember
$ 1,810
Member
New Member*
$ 1,810
$ 2,025
Nonmember
$ 2,125
$
Monday and Tuesday
Monday and Tuesday
Biotechnology
Wednesday and Thursday
See Special Pricing for Student Members, Academia/ Emerging Economies and
Government at www.ISPE.org/2011TampaConference
14
TOTAL
Member
New Member*
E01
23-24 february 21-22 February
Early Bird On or Before 24 January
Registration is confirmed only when payment is received. Please
send registration form with payment to
ISPE Headquarters, 3109 W. Dr. Martin Luther King Jr. Blvd.,
Suite 250,Tampa, Florida 33607 USA,
Main Tel: +1-813-874-1234 , +1-888-421-1442 or +1-402-592-6464
FEIN #59-2009272 • www.ISPE.org
Conference Cancellations - Cancellations must be made in writing. If
cancellations are received by 31 January 2011, a full refund, minus a
10% handling fee (maximum of $100), will be issued. After that time, no
refunds will be granted.
If you are unable to attend, substitutions will be accepted. However,
nonmembers substituting for a Member must pay difference in fees prior
to the start of the event. ISPE is not responsible for lost airfare due to
cancellations.
TPACONF11-Broch2
General Information
How to Register
ISPE Bookstore
Online: Visit www.ISPE.org/2011TampaConference
Via Fax: Complete the registration form and fax it to: +1-813-264-2816
Via Mail: Complete the registration form and mail it with payment to:
ISPE Headquarters, 3109 W. Dr. Martin Luther King Jr. Blvd.,
Suite 250, Tampa, Florida 33607 USA
Questions? Call ISPE at tel: +1-813-960-2105, or email: ask@ispe.org
Notice
Written confirmation will be sent to you after your registration is
processed (time permitting). In order to be listed in the official delegate
roster, you must be registered and paid by 11 February.
Please use code TP1 when registering for this event.
Registration Fees
Exhibit Hall access, continental breakfasts, refreshment breaks,
lunches, and networking receptions. Hotel accommodations and hotel
fees are separate from Conference registration fees. Training Courses
include course materials binder for note taking, continental breakfasts,
refreshment breaks, lunches and access to the Exhibit Hall. Training
Course materials are not available for download.
Hotel Information
We thank you for staying at the Hyatt as this enables ISPE to meet
contract requirements. For room reservations at the Conference venue,
Grand Hyatt Tampa Bay, call tel: +1-813-874-1234. When making your
reservation by phone, mention ISPE for a discounted rate of $229 single/
double. This rate is good until 31 January 2011, or until the room block is
full, whichever comes first. Please contact the hotel as early as possible
to make your reservations to ensure you are in the headquarters hotel.
Complimentary Internet is available in guest rooms for ISPE attendees.
Conference Schedule
The registration desk will be open: Sunday 15.00 - 17.00; Monday Wednesday 07.30 - 17.30; and Thursday 07.30 - 16.00. Seminars are
scheduled to begin at 09.00 and conclude at 17.00 from Monday to
Wednesday. Thursday seminars begin at 08.00 and conclude at 16.00.
Morning and afternoon breaks are scheduled daily. Lunch will be served
each day. A la carte lunch tickets may be purchased separately onsite.
Conference Cancellations
Cancellations must be made in writing. If cancellations are received by
1 February, a full refund, minus a 10% handling fee (maximum of $100),
will be issued. After that time, no refunds will be granted. If you are
unable to attend, substitutions will be accepted. However, nonmembers
substituting for a Member must pay difference in fees prior to the start of
the event. ISPE is not responsible for lost airfare due to cancellations.
Accreditation
ISPE provides continuing education units (ISPE CEUs). ISPE CEUs are
nationally recognized units of attendance that identify those individuals
continuing their education in their chosen field or profession. For the E06,
Containment Technology Forum, CM Points for industrial hygienists have
been applied for.
Special Requirements
If you require special accommodations to participate, such as a
wheelchair-accessible room or a sign language interpreter, please attach
a written description of your needs to your registration form. If you have
questions, please contact ISPE at tel: +1-813-960-2105 or email: ask@
ispe.org. Please mark vegetarian, gluten free, or kosher, if needed, in
the Special Meal Requirement box on the registration form.
Visit the ISPE Bookstore at Tampa Conference to stock up on
the latest guidance documents from ISPE. Members receive a 20
percent discount onsite.
ISPE leaders and speakers are leading professionals in their fields.
However, in those rare circumstances where we find it necessary
to make subsitutions, every possible effort is made to provide
speakers with comparable qualifications. Agendas are subject
to change without notice. Every precaution is taken to ensure
accuracy, but ISPE cannot accept responsibility for the accuracy
of information distributed or contained in these seminars or for any
opinion expressed. Delegates’ names and addresses may be given
as part of a list to other organizations for purposes related to the
field of pharmaceutical manufacturing. If you do not wish to receive
other related information, please notify ISPE.
Know Before You Go
Visit www.ISPE.org/2011TampaConference prior to attending
the Conference for all you need to “Know Before You Go.” You will
receive an email one week prior to the event with updated details, a
delegate roster, and more.
Get Your Space at the Table Top Exhibition
The Table Top Exhibition is a popular marketing and business
development tool that guarantees excellent exposure for your
company. Don’t miss out on this opportunity to meet face-to-face
with key decision makers in the pharmaceutical and biotechnology
manufacturing industries.
Exhibit set up will be on Monday, 21 February from 12.00 - 16.00.
The exhibits will open on Monday, 21 February from 17.00 - 18.30
with the Opening Reception. Continental breakfast and
refreshment breaks will be held in the Exhibit Hall on Tuesday
and Wednesday.
The fee to exhibit is $2,600 and includes two exhibitor badges for
each exhibiting company. The table top exhibition will be limited to
60 companies.
Exhibit cancellations made up to ten weeks prior to the event will
result in a cancellation fee equal to 50% of your exhibit cost. No
refunds will be given less than ten weeks prior to the event.
Contact John Phillips at jphillips@ISPE.org, or Daniel Murphy
at dmurphy@ISPE.org.
Sponsorships
ISPE Conference Sponsorships offer your company unique
opportunities to build and reinforce name recognition, create
top-of-mind brand awareness, and develop new business. These
sponsorships provide an opportunity for you to connect with a
targeted, unique, and global audience, promote the latest technical
advancements, and demonstrate your company’s commitment to
the education of pharmaceutical and biotechnology manufacturing
industry professionals. Pinnacle, Host, Platinum, Gold, Silver, and
Bronze Top Tier Sponsorships are available as well as cyber café,
lanyards, and hotel keycards. Onsite advertising opportunities are
also available. Contact John Phillips at jphillips@ISPE.org,
or Daniel Murphy at dmurphy@ISPE.org for details.
15
NON-PROFIT ORG.
U.S. POSTAGE
3109 W. Dr. Martin Luther King Jr. Blvd.,
Suite 250 | Tampa, FL 33607
PAID
TAMPA, FL
PERMIT NO. 2661
Applying Solutions to Emerging Industry Challenges
Education Seminars
• Aseptic Processing of Sterile Products: Innovations, Regulatory
Guidance and Compliance in a Practical World
•Quality Risk Management: Focused, Practical Application
• Data Integrity: How to Verify, Validate, and Maintain
• Inspection Readiness Workshop: From Site Preparation to
Successful Execution
• Syringe Processing Workshop
• Containment: A Risk-Based Approach
• Pharmaceutical Inspections and Compliance: Current FDA
Enforcement Trends
• Energy Saving Projects - Case Studies and Tools for Saving Energy
Skill-building Training Courses
• Cleaning Validation Principles
• Containment Fundamentals
• Process Validation in Biotechnology Manufacturing
ISPE Membership:
Knowledge, Community,
Profession, and More
Find out what becoming an ISPE Member can
do for you. New Member registration fees
include a one-year ISPE membership. Visit
www.ISPE.org/join to learn more about the
many benefits of ISPE Membership.
Sponsorship and
Table Top Exhibit
Opportunities Available!
For details, see page 15 or contact John Phillips
at jphillips@ISPE.org, or Daniel Murphy
at dmurphy@ISPE.org for more information.
www.ISPE.org/2011TampaConference