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2022 PDA Annex 1 Workshop

2022 PDA Annex 1 Workshop (Amsterdam)

Sep 22 - Sep 23, 2022
Amsterdam, The Netherlands

  • Conference
  • Workshop
  • Europe
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Program Highlights

The new Annex 1 revision was recently released! At this workshop, experts on the revision will answer your most pressing questions and provide practical solutions for implementation challenges at your organization.

Overview

Dear Colleagues,

Are you concerned about the new Annex 1 revision? Do you feel you and your company needs to know more to prepare for implementation challenges? If so, this is the workshop for you. EU GMP Annex 1 is arguably the most influential and important sterile product manufacturing guidance for our industry in the past 15 years and it will be so in the next 10 more years. The revised EU GMP Annex 1 will likely be published in final form sometime between June and September of this year. The time for comments is over. Now is the time for understanding the intent of the content and seriously planning for the implementation of that content. It is important that you know what is in the EU GMP Annex 1, what has changed, why it changed, and the expectations of inspectors. Your peers have the same concerns you have and collectively addressing challenges is the best way to meet those challenges. To that end, PDA has designed the workshop that provides an interactive, useful, safe forum to discuss how your peers and you will address these new requirements. We have selected topics, as expressed by you, that provide the most interest and challenges. Experts from regulators and industry will provide their insight in presentations, Q&A, and panel discussions. You will have ample opportunity to identify, discuss and debate implementation strategies and your specific questions in smaller groups or plenary sessions. This is a unique opportunity, that you cannot afford to miss. We welcome you to the Annex 1 workshop here in Amsterdam and encourage you to actively participate and provide your valuable insight so that you will end the workshop with a clear direction to share.

Looking forward to seeing you in Amsterdam!

SCIENTIFIC PROGRAM PLANNING COMMITTEE:

  • Hal Baseman, ValSource Inc., Chair
  • Gabriele Gori, ThermoFisher Scientific, Chair
  • Frederic Ayers, Eli Lilly and Company
  • Amanda Bishop McFarland, ValSource Inc.
  • Biswarup DasGupta, Vertrex Pharmaceuticals
  • Richard Denk, SKAN AG
  • Cheryl Essex, Sanofi
  • Marc Glogovsky, ValSource Inc.
  • David Keen, Ecolab
  • Tracy Moore, TM Pharma Group Ltd.
  • Patrick Nieuwenhuizen, PharmaLex
  • Don Singer, Ecolab
  • Marcia Baroni, EBSI
  • Glenn Wright, PDA
  • Falk Klar, PDA Europe
  • Stefanie Nebelin, Manager Programs & Events, PDA Europe
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Agenda

  • Day 1
  • Day 2

  • Thursday, 22 September

    09:00 – 09:20 | Welcome and Introduction

    09:20 – 10:45 | Session 1: Overview of and Revision Process for Annex 1
    Moderator: Patrick Nieuwenhuizen, PharmaLex

    09:20 | Regulatory Perspective
    Paul Gustafson, PIC/S (pre-recorded presentation)

    09:40 | Insights from a Former Regulator
    Tracy Moore, TM Pharma Group Ltd

    10:00 | Q&A, Discussion

    10:45 – 11:15 | Break

    11:15 – 12:30 | Session 2: Principles and PQS
    Moderator: Frederic Ayers, Eli Lilly and Company

    11:15 | Using Quality Risk Management to Enable the Contamination Control Strategy
    Patrick Mains, Valsource Inc.

    11:35 | Contamination Control Strategy Development
    Cheryl Essex, Sanofi

    11:55 | Considerations of Annex 1 for Advanced Therapy Medicinal Products and Low Bioburden Products
    Biswarup Dasgupta, Vertex Pharmaceuticals

    12:15 | Q&A, Discussion

    12:30 – 13:10 | Breakout Session 1
    Attendees will discuss the implementation challenges, and what can be done to meet those challenges, associated with the topics presented in P1: Overview of and Revision Process for Annex 1 and P2: Scope, Principles, and Pharmaceutical Quality Systems.

    13:10 – 14:10 | Lunch Break and Exhibition

    14:10 – 15:25 | Session 3: Premises, and Barrier Systems
    Moderator: Marcia Baroni, Emergent BioSolutions

    14:10 | Cleanroom Design: Classification, Qualification, Air Visualization
    Frederic Ayers, Eli Lilly and Company

    14:30 | Cleanroom Operation: Disinfection, Transfer of Materials, Monitoring
    David Keen, Ecolab

    14:50 | Barrier Technologies: RABS and Isolators, Glove Integrity, Robotics, Decontamination
    Richard Denk, SKAN AG

    15:10 | Q&A

    15:25 – 16:05 | Breakout Session 2
    Attendees will discuss the implementation challenges, and what can be done to meet those challenges, associated with the topics presented in P3: Premises and Barrier Systems.

    16:05 – 16:35 | Break

    16:35 – 17:30 | Session 4: Equipment, Technology, and Utilities
    Moderator: Richard Denk, SKAN AG

    16:35 | Decontamination and Sterilization of Direct and Indirect Product Contact Surfaces
    Marcia Baroni, Emergent BioSolutions

    16:55 | Water Systems and Other Critical Utilities
    Paolo Curtò, DOC Validation-Masco Group

    17:15 | Q&A

    17:30 – 18:30 | Breakout Session 3
    Attendees will discuss the implementation challenges, and what can be done to meet those challenges, associated with the topics presented in P4: Equipment, Technology, and Utilities.

    18:30 – 20:00 | Networking Reception

  • Friday, 23 September

    08:00 – 08:20 | Day 1 Recap

    08:20 – 09:15 | Session 5: Personnel: Training, Qualification, Gowning, and Monitoring/Assessment
    Moderator: Kurt Jaecques, GSK

    08:20 | Qualification and Training
    Patrick Nieuwenhuizen, PharmaLex

    08:40 | Gowning and Personnel Monitoring
    Cheryl Essex, Sanofi

    09:00 | Q&A, Discussion

    09:15 – 09:55 | Breakout Session 4
    Attendees will discuss the implementation challenges, and what can be done to meet those challenges, associated with the topics presented in P5: Personnel Training, Qualification, Gowning, and Monitoring/Assessment.

    09:55 – 10:25 | Break

    10:25 – 11:20 | Session 6: Production Technologies Part 1
    Moderator: Patrick Mains, Valsource Inc.

    10:25 | Aseptic Processing
    Frederic Ayers, Eli Lilly and Company

    10:45 | Filtration and Pre-use Post Sterilization Integrity Testing
    Thao Vinh Le, GSK

    11:05 | Q&A, Discussion

    11:20 – 12:00 | Breakout Session 5
    Attendees will discuss the implementation challenges, and what can be done to meet those challenges, associated with the topics presented in P6: Production Technologies, Part 1 (Aseptic Processing and Filtration and Pre-Use Post Sterilization Integrity Testing).

    12:00 – 13:00 | Lunch Break and Exhibit

    13:00 – 13:55 | Session 7: Production Technologies Part 2
    Moderator: Frederic Ayers, Eli Lilly and Company

    13:00 | Container Closure Integrity Testing and Finishing
    Derek Duncan, Lighthouse Instruments

    13:20 | Production and Specific Technologies (Blow-Fill-Seal, Lyophilization, Single Use System, and Terminal Sterilization)
    Patrick Nieuwenhuizen, PharmaLex

    13:40 | Q&A, Discussion

    13:55 – 14:35 | Breakout Session 6
    Attendees will discuss the implementation challenges, and what can be done to meet those challenges, associated with the topics presented in P7: Production Technologies, Part 2 (Container Closure Integrity Testing and Finishing and Production and Specific Technologies (Blow-Fill-Seal, Lyophilization, Single Use System, and Terminal Sterilization).

    14:35 – 15:05 | Break

    15:05 – 16:30 | Session 8: Aseptic Process Simulation/Environmental Monitoring
    Moderator: Cheryl Essex, Sanofi

    15:05 | Environmental and Process Monitoring
    Kurt Jaecques, GSK

    15:25 | Aseptic Process Simulations
    Biswarup Dasgupta, Vertex Pharmaceuticals

    15:45 | Final Panel Discussion

    16:30 |Report Out

    17:00 | Closing Remarks & End of Conference

Highlighted Speakers

Frederic B. Ayers
Frederic B. Ayers
Eli Lilly and Company
Marcia C. Baroni
Marcia C. Baroni
Emergent BioSolutions
Biswarup Dasgupta
Biswarup Dasgupta
Vertex Pharmaceuticals
Richard Denk
Richard Denk
SKAN AG
Derek I. Duncan
Derek I. Duncan
Lighthouse Instruments
Vinh Thao Le
Vinh Thao Le
GSK
Patrick Mains
Patrick Mains
ValSource Inc.
Patrick Nieuwenhuizen
Patrick Nieuwenhuizen
PharmaLex Ireland
View All

Additional Information

  • Learning Objectives

    Learning Objectives

    At the completion of this workshop, participants will be able to:

    1. Gain awareness of the requirements and changes in Annex 1 and move towards compliance with the proposed changes in the revision
    2. Develop strategies for implementation and verification of the Annex 1 requirements, respectively, for their organizations
  • Why Attend

    Why Attend

     
  • Who Should Attend
    Functional Areas
    • Quality Control (Analytical)
    • Quality Control (Microbiology)
    • Quality Systems
    • Quality Compliance
    • Engineering
    • Manufacturing
    • Quality Assurance Operations
    • Regulatory Affairs
    • Technical Operations
    • Training
    • Validation
    • Facilities
    • Packaging

Got a Question? We have answers

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Travel

PLEASE READ  PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.

Hilton Amsterdam

Apollolaan 138
Amsterdam, The Netherlands

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Hilton Amsterdam
  • Accommodations

    Rate: Single Room € 219 per night*
    Rate: Double Room € 239 per night*

    * Rates are per room and night, including the following services and benefits free of charge:

    • Buffet Breakfast in the restaurant
    • Wireless Internet Connection (WI-FI)
    • VAT, Taxes and Service will apply

    Make your reservations as early as possible to guarantee your room. PDA Europe has reserved a limited number of rooms until 01 July 2022.

    Rooms are available on a first come basis and must be secured by the cut-off date to receive the PDA rate. After the cut-off date, rooms will be available at the prevailing rate based on availability.

  • Amenities

    Canalside hotel with award-winning restaurant, 15 minutes from airport and right next to the Van Gogh Museum.

    The hotel does not have a shuttle bus

    There are several options for transportation from Schiphol Airport to the hotel. Schiphol is 15KM away from the hotel, and Rotterdam 65KM.

    Limo-service

    The hotel can arrange a private driver to pick you (and fellow travellers) up. The driver will be waiting for you after luggage pick up. The price for this service is 95 euro for a sedan, 110 euro for a mini-van. If you would like to use this service, please inform the hotel at least a few days in advance.

    Car-Sharing (App & membership required)

    Sixt share cares are available at the airport and their entire fleet is hybrid. Follow the signs ‘car rental’ from arrivals and walk your way through the end and take the elevator to -2 .You will find the SIXT parking at row 99. Choose your favorite car , register it on your SIXT app and exit the parking garage.

How to Get Here

By Air

The international airport of Amsterdam is "Shiphol" located 15 km away from the hotel and conference space.

By Car

Parking is available on site, € 45.00 per day. No valid parking.

Other Options

Take the train from Schiphol to Amsterdam Zuid Station (10 minutes). From there you can either walk for approximately 15 minutes or take tram Nr. 5 (direction Amsterdam Central Station) and exit at stop Gerrit van der Veenstraat. From the tram stop it is about 5 minutes walking to the hotel.

Directions

Registration Fees

Early Registration
Registration Type Price by 24 July
Member €1.695
Non-member €1.995
Govern./Health Authority/Academic €845
Young Professional (Member) €845


Regular Registration
Registration Type Price after 24 July
Member €1.895
Non-member €2.195
Govern./Health Authority/Academic €945
Early Career Professional (Member) €945


* For this member type or discount, online registration is not available, please contact [email protected].

Group Registration Discount: Register 3 people from the same organization as a group (at the same time) for the event and receive the 4th registration free. Other discounts cannot be applied.

GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. You must have this confirmation letter to be considered enrolled in a PDA event. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. If an event is cancelled, registrants will be notified by PDA immediately and will receive a credit (registration fee paid). PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees, trainers, and exhibitors and may be used to follow up on specific areas of interest after the event. Video, photo, and audio recordings are prohibited at all PDA events.

CANCELLATION: If a cancellation request is received 30 days before the event, a credit (registration fee paid minus a 200.00 USD/EUR processing fee) will be given. No credits will be given for cancellation requests received less than 30 days before the event. Cancellation requests must be emailed to [email protected].

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