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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

PDA will host a series of workshops to educate and help the industry implement the new Annex 1 revision. PDA has and continues to be committed to developing scientifically sound, practical, technical information, and training programs to advance science and regulation for our members and the industry as a whole.

The intent of the workshops is to highlight specific sections with critical changes and include interactive sessions to provide attendees with clear understanding of and means to implement the requirements of the new Annex 1, in order to address the regulatory expectations. PDA has developed a standardized approach for workshop topics to ensure consistency in the information delivered to the industry.

The workshops will be face-two-face, two days in length, conducted globally (U.S. and EU). They will provide an opportunity for attendees to hear from industry experts and regulators, and open discussions with their peers’ challenges and best practices.

Overview

Dear Colleagues,

Are you concerned about the upcoming revised EU GMP Annex 1? Do you feel you and your company need to know more, and as soon as possible, to remain competitive or, even worst, to avoid being unpleasantly caught off-guard? If so, you are not alone and made the right choice to attend this workshop. 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
  • Stefanie Nebelin, Manager Programs & Events, PDA
  • Sabine Hartmann, Manager Programs & Events, PDA

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

    09:20 | Regulatory Perspective

    09:40 | Industry Perspective

    10:00 | Q&A

    10:45 – 11:15 | Break

    11:15 – 12:30 | Session 2: Principles and PQS

    11:15 | Using Quality Risk Management to Enable the Contamination Control Strategy

    11:35 | Contamination Control Strategy Development

    11:55 | Considerations of Annex 1 for Advanced Therapy Medicinal Products and Low Bioburden Products

    12:15 | Q&A

    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

    14:10 | Cleanroom Design: Classification, Qualification, Air Visualization

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

    14:50 | Barrier Technologies: RABS and Isolators, Glove Integrity, Robotics, Decontamination

    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

    16:35 | Decontamination and Sterilization of Direct and Indirect Product Contact Surfaces

    16:55 | Water Systems and Other Critical Utilities

    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

    08:20 | Qualification and Training

    08:40 | Gowning and Personnel Monitoring

    09:00 | Q&A

    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

    10:25 | Aseptic Processing

    10:45 | Filtration and Pre-use Post Sterilization Integrity Testing

    11:05 | Q&A

    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

    13:00 | Container Closure Integrity Testing and Finishing

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

    13:40 | Q&A

    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

    15:05 | Environmental and Process Monitoring

    15:25 | Aseptic Process Simulations

    15:45 | Final Panel Discussion

    16:30 |Report Out

    17:00 | Closing Remarks & End of Conference

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

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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

Make a Reservation
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.

How to Get Here

By Air

The international airport of Amsterdam is "Shiphol" located 66 km away from the hotel and conference space.

By Car

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

Other Options

From international airport "Schiphole" you can take the bus every 8 minutes, taking approximately 35 minutes to the station "Emmastraat". From here it is only a 7 min walk by food.

Directions

Registration Fees

Early Registration
Registration Type Price by 24 July 2022
Member €1.695
Non-member €1.995
Govern./Health Authority/Academic €845
Young Professional (Member) €845
Regular Registration
Registration Type Price after 24 July 2022
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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