ISPE Nordic Conference
Södertälje, Sweden
Thursday 4 September, 2014
To be held at AstraZeeca
Astraallén, 15257 Södertälje
Entrance: Karlebyhus, Gätuna
New Validation Concepts
Following the FDA Guide, Process Validation: General Principles and Practices – 2011, the life science
industry is striving to adopt this innovative approach that sets new requirements on the production,
equipment, processes and people. However, adopting these new requirements has not been entirely
easy. During the seminar you will learn from others that have gone through a set of activities to comply
with the requirements, while keeping production efficient. You will learn from others’ successes and
mistakes and get to know best practices from the user’s perspective.
This conference will also bring light to current trends in the areas of commissioning and qualification of
HVAC and water systems. The event will conclude by translating all sessions into practicality by providing
a guided site tour at the AstraZeneca facilities in Södertälje, Sweden.
You are welcome to join us at this event:
ISPE Nordic Affiliate
Anna Kälvemark (ComplyiT), Annette Garcia (AstraZeneca)
Lena Romander (Pfizer), Mona Akerholm-Kaapro (Neste Jacobs)
& Ulf Danielsson (Pharmadule Morimatsu)
For Registration click here: http://www.bokonf.se/ISPE/
(Further information about registration can also be found at the end of this invitation.)
Agenda – New Validation Concepts
Start
Time
End
Time
Presentation Title
08.30
09.00
Registration and Coffee
09.00
09.15
Welcome and Introduction
09.15
09.55
Session 1:
Requirements and Enables for Continued Process Verification
Magnus Jahnsson, Pharmadule Morimatsu
10.00
10.40
Session 2:
Process Validation Lifecycle: From the process design stage through commercial production
Arnesa Vrazalica & Anneli Niemi, Pfizer
10.40
11.00
Network Break
11.40
Session 3:
A risk-based, cost effective approach to performance qualification of new or changed compendial
water systems
Roland Nordlund & Robert Sadler, AstraZeneca
11.00
Session 4:
Practical approach to Commissioning and Validation of HVAC systems from an Engineering
perspective
Marrkku Mäkinen, Elomatic
11.45
12.25
12.30
13.10
Lunch
13.10
13.50
Session 5:
From process to URS requirements and to final PPQ
Søren Damkjær, Novo Nordisk
13.50
14.00
Short Wrap Up
16.30
Session 6:
Guided Tours at AstraZeneca
3-4 groups (Each group lead to give a short wrap up of tour. Internal busses will transport each group.)
14.00
The Content and the Speakers
Session 1:
Requirements and enablers for Continued Process Verification
In the latest FDA guidance for Process Validation (CPV) there is a section on continued Process
Verification which can be applied instead of revalidation. The new draft Annex 15 to the EU GMPguidelines includes a section on Continuous Process Verification, which seems to be very similar to the
FDA guidance.
Many companies would like to apply CPV instead of revalidation, but are unsure if and how they can do it.
This presentation will discuss some of the requirements but also some of the opportunities in using CPV
in a manufacturing facility.
Magnus has more than twenty (20) years’ experience in the pharmaceutical industry,
both from the industry and from regulatory authorities. He has worked extensively in the
fields of R&D, manufacturing, QA and regulatory affairs and has held positions in
AstraZeneca, European Medicines Agency and Pharmadule. Furthermore he is also a
well-known speaker on GMP, Drug development and Regulatory subjects. Magnus is
currently the Director of Regulatory Affairs at Pharmadule, responsible for ensuring
Magnus Jahnsson GMP compliance in all deliveries. He is an expert on GMP design and CMC-registration.
Session 2:
Process Validation Lifecycle: from the process design stage through commercial
production
According to FDA’s guidance from 2011, process validation is defined as the lifecycle of the product. The
lifecycle approach comprises collection and evaluation of data, from the process design (stage 1) through
process performance qualification (stage 2), to continued process verification (stage 3). This establishes
scientific evidence that a process is capable of consistently delivering quality product.
What has Pfizer implemented to assure alignment with FDA’s guidance? Establishment of monitoring
programs during stage 3, based on process control strategies and risk based Failure Mode and Effects
Analysis (FMEA). Parameters and attributes in the monitoring program are evaluated and followed up.
This gives increased process knowledge and a tool to follow potential trends or shifts that might give
directions for improvements. The outcomes are presented in CPV (Continued Process Verification)
reports.
Anneli has more than 15 years of experience within the Biopharmaceutical fields in
process development and manufacturing. She is a Member of BPOG. Anneli is currently
a downstream Process Expert, responsible for processes in the multiproduct Biotech
facility at Pfizer Strängnäs in Sweden. She joined Pfizer in 2005 and holds a B.Sc. in
Biochemistry from Uppsala University.
Anneli Niemi
Arnesa has 15+ years of experience as a biopharmaceutical professional with experience
across quality control, process development, process engineering and compliance. She
is currently a validation specialist, responsible for validation systems in the multiproduct
Biotech facility at Pfizer Strängnäs in Sweden. Arnesa joined Pfizer in 2001 and holds a
M.Sc. in Biomedicine from University of Kalmar (Linnaeus University).
Arnesa Vrazalica
Session 3:
A risk-based, cost effective approach to performance qualification of new or changed
compendial waters systems
This presentation covers the approach taken by AstraZeneca to implement and perform risk based
performance qualification of critical water systems,
Roland, MSc, is a senior microbiologist with 18 years’ experience of validation, design
and microbial control of water systems at AstraZeneca, Södertälje. During recent years
he has been involved in risk based aseptic validation and microbiological cleaning
validation within BFS technology. In addition, he has a long experience of microbial
validation and environmental monitoring within AstraZeneca, Södertälje.
Roland Nordlund
Robert is a process engineer at the GMP Media and Clean Room Maintenance
department at AstraZeneca Sweden Operations and is responsible for design and
process optimization of water and stream systems. Robert has 15+ years of experience
of validation in the Life Science industry and 10+ years of experience of validation (DQ,
IQ, OQ and PQ) of water and steam systems, including the harmonization of validation of
water and steam systems within AstraZeneca Sweden Operations.
Robert Sandler
Session 4:
Practical approach to Commissioning and Validation of HVAC systems from an
Engineering perspective
The presentation will cover:
• Key Concepts
• Segregation between Commissioning and Validation
• V-Shape Models
• HVAC design Considerations
• HVAC related critical parameters
• GEP and GMP limits for HVAC
• Commissioning and Qualification of HVAC
Markku Mäkinen
Markku has 30+ years of experience in engineering, particularly HVAC-design projects
for cleanroom within Pharma and life science. His vast international pharma and life
science experience stretches from the Nordic countries, Russia, Turkmenistan, Taiwan to
India and Bangladesh. He is currently a leading engineer, speaker and trainer for
Elomatic, Turku University of Applied Sciences and AEL which is a leading provider of
technical training. Markku is a member of ISPE and R3-Nordic. He holds an M.Sc. in Civil
Engineering/Building Services and a B.Sc. in HVAC.
Session 5:
From process to URS requirement and to final PPQ
This presentation will show how the link between Quality Risk Management and Validation has been
implemented at Novo Nordisk. The reference will be FDA Process Validation Guideline, Jan, 2011. Topics
to be covered are:
• Identifying CQA from Process Design
• Use of QRM in Validation
• Defining URS – challenges in projects
• Dynamic in processes
• Prepare for PPQ
Søren Damkjær
Søren has an M.Sc. in biochemistry from Copenhagen University in 1996 and has been
working with GMP, quality assurance, validation and regulatory since then. He has
served several companies but most recently at H. Lundbeck A/S and now Novo Nordisk
A/S. In the last 10 years Søren worked as a validation specialist, setting standards across
Novo Nordisk A/S for validation, implementing new requirements in validation projects
including the FDA process validation guideline from 2011.
For seminar registration please click here: http://www.bokonf.se/ISPE/
Conference Fee:
Category
Member
Non-member
Industry
€ 175
€ 415 *
Academia, Regulatory & YP
€ 110
€ 210*
Students
€ 75
€ 100*
*) Includes a 1 year membership in ISPE
Table Top Exhibition:
This conference is an excellent opportunity to meet people working with all kinds of
aspects within Pharmaceutical Production. We can offer a limited number of table top
exhibition possibilities for only €500 (excl. conference fee). Contact us for further
information.
Questions regarding registration:
B.O. Conference Service, Bengt Österlund; info@bo-conf.com, +46 705 320438
Questions regarding the event:
Lena Romander, Pfizer, (ISPE Nordic Affiliate), lena.romander@pfizer.com +46 768
773 607
Event Sponsor:
Välkommen till AstraZeneca Södertälje
Welcome to AstraZeneca Södertälje