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2023 PDA Annex 1 Workshop

2023 PDA Annex 1 Workshop (Raleigh)

Feb 27 - Feb 28, 2023
Raleigh, NC

  • Workshop
  • The Americas
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Program Highlights
The 2023 PDA Annex 1 Workshop (Raleigh) is sold out! To be added to the wait list, please email [email protected].

Overview

Back by popular demand, the 2023 PDA Annex 1 Workshop (Raleigh) is designed to educate and help the industry implement the new Annex 1 revision. PDA has been, 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 Workshop will 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.

This workshop will provide an opportunity for attendees to hear from industry experts and regulators, and open discussions with their peers’ challenges and best practices.

SUBJECT MATTER EXPERTS

  • Frederic B. Ayers, Research Scientist, Eli Lilly and Company and Workshop Co-Chair
  • Tracy Moore, Director, TM Pharma Group Ltdand Workshop Co-Chair
  • Bianca Bohrer, Managing Director, PSM GmbH
  • Angie L. Bragdon, MS, Senior Principal Scientist - Sterility Assurance Technology, Eli Lilly and Company
  • Richard Denk, Senior Consulting Aseptic Processing & Containment, SKAN AG
  • Irving Ford, MSc, VP of Quality, Adaptimmune
  • Marc Glogovsky, MS, Business Unit Manager/Senior Consultant – Microbiology, Valsource, Inc.
  • Thorsten Haefner, MBA, Vice President of Business Development, PSM GmbH
  • Amanda M. McFarland, MS, Senior Consultant, ValSource, Inc.
  • William Peterson, Associate Director of Engineering, Merck & Co., Inc.
  • Mike J. Sadowski, Lead Scientist, Baxter Healthcare
  • Kim Sobien, MBA, MSAT Contamination Control Lead and GSK Fellow, GSK
  • Oliver P. Stauffer, MBA, CEO, Packaging Technologies & Inspection LLC
  • LT Seneca D. Toms, MS, MSEH, RAC, National Expert, Drugs, ORA, U.S. FDA
  • James Wamsley, Consultant, ValSource, Inc.
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Agenda

  • Day 1
  • Day 2

  • MONDAY, 27 FEBRUARY

    07:00 – 18:00 | Registration Open

    07:00 – 08:00 | Continental Breakfast

    08:00 – 09:30 | P1: Overview of and Revision Process for Annex 1
    Moderator:     Frederic B. Ayers, Research Scientist, Eli Lilly and Company

    Over the past four years, the revised Annex 1 has gone through multiple sets of industry review, comment, and revision. The current version presents a diverse, international perspective on regulatory expectations, recommendations, and requirements for modern sterile drug and biologic product manufacturing. The revised Annex 1 contains a significant amount of new and more detailed content on many topics. It places a heightened emphasis on the use of risk-based assessment and approaches to design and evaluate manufacturing contamination control. This session will provide insights from regulatory authorities involved in the Annex 1 development and review process of the revision, with a focus on the evolution, planning, and implementation of these changes.

    08:00 | Welcome Remarks from Workshop Co-Chairs
    Frederic B. Ayers, Research Scientist, Eli Lilly and Company
    Tracy Moore, Director, TM Pharma Group Ltd

    08:20 | Regulatory Perspective
    Regulatory Representative Invited

    08:40 | Insights from a Former Regulator
    Tracy Moore, Director, TM Pharma Group Ltd

    09:00 | Q&A

    09:30 – 10:00 | Break in Exhibit Area

    10:00 – 11:00 | P2: Scope, Principles and Pharmaceutical Quality Systems
    Moderator: Frederic B. Ayers, Research Scientist, Eli Lilly and Company

    This session opens our in-depth look at the content of the draft Annex 1. The Scope, Principles, and Pharmaceutical Quality System sections introduce the vision of the Annex 1 changes that track through all other sections. Talks will highlight Annex 1 focal points including contamination control strategy, quality risk management, and quality culture, including a discussion on the importance of human factors: knowledge, attitude, and experience. This session will also address the expanded scope of Annex 1 to include some non-steriles.

    10:00 | Using Quality Risk Management to Enable the Contamination Control Strategy
    Amanda M. McFarland, MS, Senior Consultant, ValSource Inc.

    10:20 | Contract Manufacturing Organizations
    Thorsten Haefner, MBA, Vice President of Business Development, PSM GmbH

    10:40 | Considerations of Annex 1 for Advanced Therapy Medicinal Products and Low Bioburden Products
    Irving Ford, MSc,     VP of Quality, Adaptimmune

    11:00 – 11:45 | 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.

    11:45 – 13:00 | Lunch

    13:00 – 14:00 | P3: Premises and Barrier Systems
    Moderator: Angie L. Bragdon, MS, Senior Principal Scientist - Sterility Assurance Technology, Eli Lilly and Company

    Aseptic manufacturing facilities come in a variety of shapes and sizes, from traditional aseptic through restricted access barrier systems (RABS) and into Isolators. This session will take a look at some of the key design and operational aspects that have been impacted by the revised Annex 1.

    13:00 | Cleanroom Design: Classification, Qualification, Air Visualization
    Frederic B. Ayers, Research Scientist, Eli Lilly and Company

    13:20 | Cleanroom Operation: Disinfection, Transfer of Materials, Monitoring
    Kim Sobien, MBA,     MSAT Contamination Control Lead and GSK Fellow, GSK

    13:40 | Barrier Technologies: RABS and Isolators, Glove Integrity, Robotics, Decontamination
    Richard Denk, Senior Consulting Aseptic Processing & Containment, SKAN AG

    14:00 – 14:45 | 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.

    14:45 – 15:15 | Break in Exhibit Area

    15:15 – 16:15 | P4: Equipment, Technology, and Utilities
    Moderator: Richard Denk, Senior Consulting Aseptic Processing & Containment, SKAN AG

    This session will discuss the impact of the Annex 1 revision on aseptic manufacturing facilities, specifically focusing on equipment design, indirect product contact parts, such as stopper bowls, and critical utilities, such as water systems.

    15:15 | Material Transfer
    Tracy Moore, Director, TM Pharma Group Ltd

    15:35 | Decontamination and Sterilization of Direct and Indirect Product Contact Surfaces
    Richard Denk,     Senior Consulting Aseptic Processing & Containment, SKAN AG

    15:55 | Aseptic Process Simulations
    Angie L. Bragdon, MS, Senior Principal Scientist - Sterility Assurance Technology, Eli Lilly and Company

    16:15 – 17:00 | 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.

    17:00 – 17:30 | Day 1 Q&A and Panel Discussion
    Moderator: Marc Glogovsky, MS, Business Unit Manager/Senior Consultant – Microbiology, Valsource, Inc.

    17:00 | Q&A and Panel Discussion with Day 1 Presenters
    Frederic B. Ayers,     Research Scientist, Eli Lilly and Company
    Angie L. Bragdon, MS, Senior Principal Scientist - Sterility Assurance Technology, Eli Lilly and Company
    Richard Denk,     Senior Consulting Aseptic Processing & Containment, SKAN AG
    Irving Ford, MSc, VP of Quality, Adaptimmune
    Thorsten Haefner, MBA, Vice President of Business Development, PSM GmbH
    Amanda M. McFarland MS, Senior Consultant, ValSource Inc.
    Tracy Moore, Director, TM Pharma Group Ltd
    Kim Sobien, MBA, MSAT Contamination Control Lead and GSK Fellow, GSK
    LT Seneca D. Toms, MS, MSEH, RAC, National Expert, Drugs, OMPTO, ORA, U.S. FDA

    17:30 – 18:30 | Networking Reception in Exhibit Area

  • TUESDAY, 28 FEBRUARY

    07:00 – 17:00 | Registration Open

    07:00 – 08:00 | Continental Breakfast

    08:00 – 09:00 | P5: Personnel Training, Qualification, Gowning, and Monitoring/Assessment
    Moderator: Marc Glogovsky, MS, Business Unit Manager/Senior Consultant – Microbiology, ValSource, Inc.

    Training and qualifying operators are of critical importance to ensuring proper aseptic technique and cleanroom behavior. Routine monitoring of personnel ensures that the qualified personnel are following the established procedures and that they can meet the strict gowning cleanliness requirements during normal operations. Trending and analysis of gloves and gown environmental monitoring (EM) data can provide critical feedback on individual operator performance, potential routes of contamination, specific gowning procedures, and overall training efficacy.

    08:00 | Day 1 Report Out
    Tracy Moore, Director, TM Pharma Group Ltd

    08:20 | Qualification and Training
    Angie L. Bragdon, MS, Senior Principal Scientist - Sterility Assurance Technology, Eli Lilly and Company

    08:40 | Gowning, Personnel Monitoring, and Beyond
    Frederic B. Ayers, Research Scientist, Eli Lilly and Company

    09:00 – 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 | Break in Exhibit Area

    10:15 – 11:00 | P6: Production Technologies, Part 1
    Moderator: Amanda M. McFarland, MS, Senior Consultant, ValSource, Inc.

    This session will focus on the Annex 1 requirements for aseptic processing and filtration of sterile products. The aseptic processing discussion will address the types of operations and grades needed for aseptic preparation and processing operations. The filtration and sterilization presentation will provide insight into the different types of sterilization and the parameters needed to demonstrate success.

    10:15 | Aseptic Processing
    Frederic B. Ayers, Research Scientist, Eli Lilly and Company

    10:35 | Filtration and Pre-Use Post Sterilization Integrity Testing
    William Peterson, Associate Director of Engineering, Merck & Co., Inc.

    11:00 – 11:45 | 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).

    11:45 – 13:00 | Lunch

    13:00 – 13:40 | P7: Production Technologies, Part 2
    Moderator: Tracy Moore, Director, TM Pharma Group Ltd

    This session will introduce some of the more intriguing topics covered and expanded in the revised Annex 1, which were selected based on input from the sterile product manufacturing community, as noted during prior meetings and discussions.

    13:00 | Container Closure Integrity Testing and Finishing
    Oliver P. Stauffer, MBA, CEO, Packaging Technologies & Inspection LLC

    13:20 | Production and Specific Technologies (Blow-Fill-Seal, Lyophilization, Single Use System, and Terminal Sterilization)
    Mike J. Sadowski,     Lead Scientist, Baxter Healthcare

    13:40 – 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 | Break in Exhibit Area

    15:00 – 16:30 | P8: Aseptic Process Simulation and Environmental Monitoring
    Moderator: Amanda M. McFarland, MS, Senior Consultant, ValSource, Inc.

    Aseptic process simulation (APS) has been identified as one of the key aspects of aseptic process control and monitoring. This session will review the related changes and begin discussing the interpretation and implementation of these recommendations and requirements. The presentations will focus on the Annex 1 requirements for APS (media fills) and environmental and process monitoring, including the new requirements and considerations for qualifying and operating a clean area and the extensive new requirements needed to successfully validate an aseptic process.

    15:00 | Environmental and Process Monitoring
    Marc Glogovsky, MS,     Business Unit Manager/Senior Consultant – Microbiology, ValSource, Inc.

    15:20 | Contamination Control Strategy Development
    James Wamsley, Consultant, ValSource, Inc.

    15:40 | Day 2 Report Out, Q&A, and Panel Discussion
    Frederic B. Ayers,     Research Scientist, Eli Lilly and Company
    Angie L. Bragdon, MS, Senior Principal Scientist - Sterility Assurance Technology, Eli Lilly and Company
    Marc Glogovsky, MS, Business Unit Manager/Senior Consultant – Microbiology, Valsource, Inc.
    William Peterson,     Associate Director of Engineering, Merck & Co., Inc.
    Mike J. Sadowski, Lead Scientist, Baxter Healthcare
    Oliver P. Stauffer, MBA,     CEO, Packaging Technologies & Inspection LLC
    LT Seneca D. Toms, MS, MSEH, RAC, National Expert, Drugs, ORA, U.S. FDA
    James Wamsley, Consultant, ValSource, Inc.

    16:25 | Closing Remarks from Workshop Co-Chairs
    Frederic B. Ayers, Research Scientist, Eli Lilly and Company
    Tracy Moore, Director, TM Pharma Group Ltd

Networking Opportunities

MONDAY, 27 FEBRUARY

  • 09:30 – 10:00 | Refreshment Break in the Exhibit Area
  • 11:45 – 13:00 | Networking Lunch
  • 14:45 – 15:15 | Refreshment Break in the Exhibit Area
  • 17:30 – 18:30 | Reception in the Exhibit Area

TUESDAY, 28 FEBRUARY

  • 09:45 – 10:15 | Refreshment Break in the Exhibit Area
  • 11:45 – 13:00 | Networking Lunch
  • 14:30 – 15:00 | Refreshment Break in the Exhibit Area

Highlighted Speakers

Frederic B. Ayers
Frederic B. Ayers
Eli Lilly and Company
Angie L. Bragdon
Angie L. Bragdon
Eli Lilly and Company
Richard Denk
Richard Denk
SKAN AG
Irving Ford
Irving Ford
Adaptimmune
Marc Glogovsky
Marc Glogovsky
Valsource, Inc.
Amanda McFarland
Amanda McFarland
ValSource, Inc.
Tracy Moore
Tracy Moore
TM Pharma Group Ltd
Oliver P. Stauffer
Oliver P. Stauffer
Packaging Technologies & Inspection LLC
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
  • 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.

Raleigh Convention Center

500 South Salisbury Street
Raleigh, NC

Raleigh Convention Center

The Workshop will take place at the Raleigh Convention Center (500 S Salisbury Street). PDA does not have a block of hotel room, but recommends these nearby hotels:

  • Raleigh Marriott City Center
  • Residence Inn Raleigh Downtown
  • Sheraton Raleigh

    • How to Get Here

    By Air

    Raleigh-Durham International Airport is approximately 20 minutes northwest of the RCC. Ground transportation to and from the airport is provided by the Raleigh-Durham International Airport Taxi Service, GoTriangle, and local limousine and shuttle companies. Many hotels also offer shuttle service to and from the airport.

    By Car

    The Raleigh Convention Center is adjacent to the Red Hat Amphitheater and is located at 500 South Salisbury Street, Raleigh, NC 27601. From Points West: I-40 east to exit 298B South Saunders Street. From Points East: 64/264 to I-440 east; merge onto I-40 west and exit at 298B South Saunders Street. From Points South: US-1 north to I-40 east; exit at 298B South Saunders Street. From Points North: US-1 South into the city - left on Lenoir Street.

    Other Options

    The regional bus system, GoTriangle, offers service throughout the Greater Raleigh and Triangle area. Stops are located throughout Downtown Raleigh and can take visitors to neighboring such as Cary, Morrisville, Research Triangle Park, Durham, and Chapel Hill. Visit gotriangle.org for more information.

    Directions

    Registration Fees

    Early Registration
    REGISTRATION TYPE BY 29 JANUARY
    Member $1,995
    Non-Member $2,395
    Gov./Health Authority/Academic (Member Only) $795
    Early Career Professional (Member Only) $1,295
    Student (Member Only) $495
    Regular Registration
    REGISTRATION TYPE AFTER 29 JANUARY
    Member $2,495
    Non-Member $2,895
    Gov./Health Authority/Academic (Member Only) $895
    Early Career Professional (Member Only) $1,395
    Student (Member Only) $595

    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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