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2022 PDA Annex 1 Workshop

2022 PDA Annex 1 Workshop (Dublin)

May 18 - May 19, 2022
Dublin, Ireland

  • Workshop
  • Europe

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COVID-19 Information: At present, no pandemic-related measures apply to entry into Ireland. No entry forms are required, no negative test results need to be presented upon entry and there is no quarantine obligation for people entering Ireland. In public transport as well as in hospitals, retirement, or nursing homes there is an obligation to wear a medical mask. To view the current entry requirements for Ireland, please visit the official site of Government of Ireland gov.ie
You can find further details on the removal of the Irish government’s measures here and at gov.ie As of 06 March 2022
Program Highlights

JUST CONFIRMED: Paul Sexton, GMP/GDP Inspector, Health Products Regulatory Authority (HPRA)

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-2-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 Dublin 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 Dublin!

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
  • Sabine Hartmann, Manager Programs & Events, PDA
  • Stefanie Nebelin, Manager Programs & Events, PDA

Agenda

  • Day 1
  • Day 2
  • Wednesday, 18 May

    09:00 – 09:20 | Welcome and Introduction

    09:20 – 10:30 | P1: Overview of and Revision Process for Annex 1
    Moderator: Gabriele Gori, ThermoFisher Scientific

    09:20 | Regulatory Perspective
    Paul Sexton, HPRA

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

    10:00 | Q&A & Panel Discussion 

    10:30 – 11:00 | Coffee Break, Poster Session & Exhibition 

    11:00 – 12:15 | P2: Scope, Principles, and Pharmaceutical Quality Systems
    Moderator: Alan Dake, Merck

    11:00 | Using Quality Risk Management to Enable the Contamination Control Strategy
    Amanda Bishop McFarland, ValSource Inc.

    11:20 | Contamination Control Strategy Development
    Cheryl Essex, Sanofi

    11:40 | Considerations of Annex 1 for Advanced Therapy Medicinal Products and Low Bioburden Products
    Marc Glogovsky, ValSource Inc.

    12:00 | Q&A

    12:15 – 12:20 | Transition into Breakout Groups

    12:20 – 13:00 | 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.

    13:00 – 14:00 | Lunch Break, Poster Session & Exhibition

    14:00 – 15:15 | P3: Premises and Barrier Systems
    Moderator: Patrizia Muscas, Eli Lilly and Company

    14:00 | Cleanroom Design: Classification, Qualification, Air Visualization
    Alan Dake, Merck

    14:20 | Cleanroom Operation: Disinfection, Transfer of Materials, Monitoring
    David Keen, Ecolab

    14:40 | Barrier Technologies: RABS and Isolators, Glove Integrity, Robotics, Decontamination
    Richard Denk, SKAN AG

    15:00 | Q&A

    15:15 – 15:20 | Transition into Breakout Groups

    15:20 – 16:00 | 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.

    16:00 – 16:30 | Coffee Break, Poster Session & Exhibition

    16:30 – 17:45 | P4: Equipment, Technology, and Utilities 
    Moderator: Richard Denk, SKAN AG

    16:30 | Decontamination and Sterilization of Direct and Indirect Product Contact Surfaces
    Patrizia Muscas, Eli Lilly and Company

    16:50 | Water Systems and Other Critical Utilities
    Paolo Curto, DOC – MASCO GROUP

    17:10Q&A

    17:30 – 17:35 | Transition into Breakout Groups

    17:35 – 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 | End of Workshop Day 1 & Networking Reception

  • Thursday, 19 May

    08:00 – 08:20 | Welcome and Day 1 Recap

    08:20 – 09:15 | P5: Personnel Training, Qualification, Gowning, and Monitoring/Assessment
    Moderator: Kurt Jaecques, GSK

    08:20 | Qualification and Training
    Patrizia Muscas, Eli Lilly and Company

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

    09:00 | Q&A

    09:15 – 09:20 | Transition into Breakout Groups

    09:20 – 09:45 | 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.

    09:45 – 10:15 | Coffee Break, Poster Session & Exhibition

    10:15 – 11:20 | P6: Production Technologies, Part 1
    Moderator: Amanad Bishop McFarland, ValSource Inc.

    10:15 | Aseptic Processing
    Alan Dake, Merck

    10:45 | Filtration and Pre-use Post Sterilization Integrity Testing
    Maik Jornitz, G-Con Manufacturing Inc.

    11:00 | Q&A

    11:15 – 11:20 | Transition into Breakout Groups

    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, Poster Session & Exhibition

    13:00 – 13:50 | P7: Production Technologies, Part 2.
    Moderator: Gabriele Gori, ThermoFisher, Scientific

    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

    13:55 – 14:00 | Transition into Breakout Groups

    14:00 – 14:30 | 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)).

    14:30 – 15:00 | Coffee Break, Poster Session & Exhibition 

    15:00 – 16:45 | P8: Aseptic Process Simulation/Environmental Monitoring
    Moderator: Cheryl Essex, Sanofi

    15:00 | Environmental and Process Monitoring
    Kurt Jaecques, GSK

    15:20 | Aseptic Process Simulations 
    Gabriele Gori, ThermoFisher Scientific

    15:40 | Day 2 Report Out

    16:00 | Q&A and Final Panel Discussion

    16:45 | Closing Remarks & End of Workshop

Highlighted Speakers

Hal Baseman
Hal Baseman
ValSource Inc.
Paolo Curtò
Paolo Curtò
DOC Validation-Masco Group
Alan E. Dake
Alan E. Dake
Merck & Co., Inc.
Cheryl E. Essex
Cheryl E. Essex
Sanofi
Gabriele Gori
Gabriele Gori
ThermoFisher Scientific
Tracy Moore
Tracy Moore
TM Pharma Group Ltd
Patrizia Muscas
Patrizia Muscas
Eli Lilly and Company
Paul Sexton
Paul Sexton
HPRA

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

    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
  • Who Should Attend
    Pharma Companies
    • Biopharmaceutical Companies
    • Start-ups/Emerging Companies
    Suppliers/Vendors
    • Raw Materials
    • Consumables
    • Equipment
    Governmental Health Authorities
    • National/Local Authorities
    • European Authorities
    • International Authorities
    Service Providers
    • CDMOs
    • Contract Test Laboratories
    • Logistic Companies
    Consultancy
    • Freelancer
    • Consulting Firms
    Academia
    • Universities
    • Academic Research Institutes

Got a Question? We have answers

Contact Us

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.

Crowne Plaza Dublin Airport

Northwood Park, Dublin 9, Santry Demesne
Dublin, Ireland

Crowne Plaza Dublin Airport

https://www.cpireland.crowneplaza.com/dublin-airport

PLEASE NOTE

For accommodation PDA recommends the Carlton Hotel Dublin Airport. Distance to conference venue: 1.7km

There will be also a shuttle service provided from the Carlton Hotel Dublin Airport to the conference venue Crowne Plaza Dublin Airport in the morning as well after the end of each conference day.

  • Accommodations

    Carlton Hotel Dublin Airport

    Old Airport Rd, Cloghran,
    Dublin, K67 P5C7,
    Ireland
    Tel: +353 1 866 7500
    www.carltondublinairport.com 

    Rate: Single Room € 150 per night*
    Rate: Double Room € 160 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 28 March 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

    The Carlton Hotel Dublin Airport is a 4-star modern boutique hotel, located just off the M1 & M50 motorways, only 4 minute’s drive from the conference venue Crowne Plaza Dublin Airport. The hotel provides a 24-hour shuttle bus service to and from the airport for all guests as well as ample on-site parking.

    There will be also a shuttle service provide from the conference venue to the Carlton hotel in the morning as well after the end of the conference.

     

How to Get Here

By Air

The Crowne Plaza Dublin Airport is 3 km away from Dublin International Airport

By Car

The Crowne Plaza Dublin Northwood is set in parkland, close to highways M1 and M50, and 15 minutes from central Dublin. At Crowne Plaza Dublin Airport, self-parking is available for a daily rate of 6 EUR.

Other Options

The nearest train station is Connolly Station

Directions

Registration Fees

Early Registration
Registration Type Price by 20 March
Member €1.695
Non-member €1.995
Govern./Health Authority/Academic €845
Early Career Professional (Member) €845

Regular Registration
Registration Type Price after 20 March
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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