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2023 PDA Annex 1 Workshop

2023 PDA Annex 1 Workshop (Charlotte)

Dec 04 - Dec 05, 2023
Charlotte, NC

  • Workshop
  • The Americas
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Program Highlights

The PDA Annex 1 Workshop in Raleigh sold out earlier this year! Make sure to register by 22 October to save up to $500 in registration fees!

Overview

PDA is delighted to announce we will be hosting two workshops to educate and help the industry with the August 2023 implementation of the new EU GMP 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.

The intent of the workshops is to address the challenges and implications that have arisen with the implementation of the new EU GMP Annex 1. These workshops, scheduled for November and December, will focus on examining specific sections with critical changes and facilitating interactive sessions to provide attendees with a clear understanding of how to navigate and successfully meet the requirements of the revised EU GMP Annex 1. PDA has developed a standardized approach for workshop topics, ensuring that the information delivered to the industry remains consistent and relevant to the current regulatory landscape.

The workshops will be face-to-face, two days in length, and 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.

SUBJECT MATTER EXPERTS

  • Frederic Ayers, ValSource, Inc. (Co-Chair)
  • Tracy Moore, TM Pharma Group Ltd (Co-Chair)
  • Angie Bragdon, Eli Lilly and Company
  • Richard Denk, SKAN AG
  • Chris Knutsen, Bristol-Myers Squibb
  • Amanda McFarland, ValSource, Inc.
  • Christopher Murdock, Bristol-Myers Squibb
  • Don Singer, Ecolab Life Sciences
  • Kim Sobien, ValSource, Inc.
  • Oliver Stauffer, Packaging Technologies & Inspection LLC
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Agenda

  • Day 1
  • Day 2

  • MONDAY, 04 DECEMBER

    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, Senior Consultant, ValSource, Inc.

    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, Senior Consultant, ValSource, Inc.
    Tracy Moore, Director, TM Pharma Group Ltd

    08:20 | Regulatory Perspective
    Regulatory Representative Invited

    08:45 | Insights from a Former Regulator
    Tracy Moore, Director, TM Pharma Group Ltd

    Insights from the perspective of the regulator on Annex 1. There were 4 main topic areas which received a bulk of the comments which will be touched on in this discussion.

     09:05 | Q&A with Additional Panelists

    Industry Representative Invited

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

    10:00 – 11:00 | P2: Scope, Principles and Pharmaceutical Quality Systems
    Moderator: Frederic B. Ayers, Senior Consultant, ValSource, Inc.

    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.

    The application of risk management and risk principles has been identified in Annex 1 as a foundational element for developing a robust contamination control strategy (CCS). Overall CCS goals would include definition of critical control points, evaluation of control effectiveness, and technical/process knowledge – all factors which can be integrated into robust risk activities. This presentation will evaluate the language used to describe risk activities, where those activities are required, and explore risk assessment tools that will enable the contamination strategy goals.

    10:20 | Contract Manufacturing Organizations
    Marcia C. Baroni,     Vice President Enterprise GxP Compliance & Systems, Emergent Biosolutions 

    10:40 | Considerations of Annex 1 for Advanced Therapy Medicinal Products and Low Bioburden Products
    Industry Representative Invited

    With the publication of EU GMP guideline Part IV: GMP Requirements for Advanced Therapy Medicinal Products (Guidelines on Good Manufacturing Practice specific to Advanced Therapy Medicinal Products (ATMPs), there are discussions in the industry if Part III: Annex 1: “Manufacture of Sterile Medicinal Products” is still applicable for ATMPs. This presentation is intended to provide clarity in terms of regulatory requirements vs. examples of best practices that can be utilized from Annex 1 during the manufacture of ATMPs. PIC/S Annex 2A will also be discussed with an aim to understand legal and technical applicability and how it can be used to bridge requirements and support a consistent approach that is as jurisdiction-wide/agnostic as possible.

    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
    Marcia C. Baroni, Vice President Enterprise GxP Compliance & Systems, Emergent BioSolutions

    Cleanroom design is a critical balance of engineering and operational processes that are required to meet regulatory guidelines. This presentation will provide considerations for meeting those requirements and maintaining a cleanroom.

    13:20 | Cleanroom Operation: Disinfection, Transfer of Materials, Monitoring
    Kim Sobien, MBA, Senior Consultant-Microbiology, ValSource, Inc.

    Annex 1 changes reflect a distinction between cleaning and disinfection, acceptance of supplier-approved documentation for ready-made disinfectants, and improved clarity of the ownership of disinfection validation. The proper use of sterilization or disinfection for transfer of materials has also been clarified, along with specific instances where microbiological monitoring is recommended. This presentation will facilitate discussion for improved understanding and approaches for these changes.

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

    Barrier technologies, such as RABS and isolators, are mentioned 32 times in the revised Annex 1 and their use should be considered in the contamination control strategy. Besides barriers, glove management and the integrity of the gloves should be demonstrated. Validated decontamination cycle using vaporized or nebulized hydrogen peroxide as well as robotics system to minimize manual intervention will be presented.

     

    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 | Networking Break in the 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

    The uncertainties surrounding the sterilization of direct and indirect product contact surfaces has been a hot topic since the first publication of the draft Annex 1 in 2017. While intuitively there is no question it should be done, when it comes to indirect contact parts in an isolator environment, the practical and logistical implications are numerous, especially when you introduce the option or surface decontamination. This presentation will focus on different options and points to consider when making the right selection for your process.

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

    Proper design and implementation of APS are key in supporting the verification of the capability of the overall manufacturing process to prevent product contamination. This presentation will review and clarify the comprehensive set of new requirements and expectations that are listed in the revised Annex 1.

    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: 

    Kim Sobien, MBA, Senior Consultant-Microbiology, ValSource, Inc.

     

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

  • TUESDAY, 05 DECEMBER

    07:00 – 16:00 | Registration Open

    07:00 – 08:00 | Continental Breakfast

    08:00 – 09:00 | P5: Personnel Training, Qualification, Gowning, and Monitoring/Assessment
    Moderator: Amanda M. McFarland, MS, Senior Consultant, 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

    The revised Annex 1 draft has significantly increased the depth and breadth of requirements surrounding personnel qualification and training. However, are these truly new requirements, or has there simply been a formalization of pre-existing industry practices? This presentation will discuss these requirements and what it means for your operations, as well as exploring some options for implementation.

    08:40 | Gowning, Personnel Monitoring, and Beyond
    Frederic B. Ayers, Senior Consultant, ValSource, Inc.

    The Annex 1 revision has added more details to an already prescriptive set of requirements on personnel gowning and monitoring. In this presentation, the explicit new expectations will be reviewed and the broader Annex 1 theme of personnel awareness and monitoring beyond the contact plate will be discussed.

    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 | Networking Break in the 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 – 10:35 | Aseptic Processing
    Frederic B. Ayers, Senior Consultant, ValSource, Inc.

    This presentation will provide clarity on some of the changes related to aseptic procession simulation (APS) as it is important to note the proposed addition of “a demonstrated aseptic proficiency in the performance of aseptic process activities” in place of the requirement for “participation in a successful APS” is not designed to exclude the use of APS.

    10:35 – 11:00 | Filtration and Pre-Use Post Sterilization Integrity Testing 
    William Petersen, Associate Director of Engineering, Merck & Co., Inc.

         This presentation will highlight the use of risk-based assessments (as noted in the PDA consortium publications) to determine what controls are needed to mitigate and prevent filter related risks, where Pre-Use Post Sterilization Integrity Testing (PUPSIT) is determined to be a sound (or appropriate) method for risk mitigation and process control, along with considerations to better design and control the PUPSIT process.

    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 | Networking Break in the Exhibit Area

    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, Packing Technologies & Inspection LLC

    Annex 1 changes reflect more prescriptive recommendations for testing container closure integrity (CCI) of finished products. Ampules are no longer the only containers suggested for 100% “leak testing.” The inclusion of flexible bags for 100% leak testing is a significant new recommendation that will be challenging to meet for users and flexible container suppliers. Validated methods for leak tests are now prescribed, as well as concrete language for validation of CCI for transport and shipping. For container types not specifically mentioned in Annex 1, guidance is given that testing programs should be based on knowledge of the container closure system and the process being used, implying that robust CCI data should perhaps be available from development and scale-up activities. This presentation will facilitate discussion for improved understanding and approaches for these changes reflecting CCI testing.

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

    Annex 1 outlines a number of technologies for filling and finishing of sterile products, including blow-fill-seal (BFS) and lyophilization. Equipment and facility design and (in-process) controls are important aspects that contribute to the overall sterility assurance of the finished product. This presentation will outline some points of attention when it comes to (aseptic) filling using BFS and lyophilization technology. It zooms in on terminal sterilization of products, or better, the limitations of terminal sterilization and requirements for aseptic manufacturing where terminal sterilization is not possible. Prevention of contamination is key in aseptic manufacturing and the presentation will discuss the use of single-use technology vs. stainless steel set-ups, with their respective pros and cons.

    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 | Networking Break in the Exhibit Area

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

    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
    Ivy Louis, Founder-Director, VIENNI TRAINING & CONSULTING LLP

    The importance of a firm’s EM program to support and provide direct feedback on a given contamination control strategy is a renewed focus in the Annex 1 revision. This presentation will highlight some of the changes and areas of consideration and will discuss implementation of EM risk assessments, importance of appropriate monitoring equipment, monitoring during various operational conditions, and data trending. The challenges of increased personnel monitoring and utilization of rapid microbiological methods will also be addressed.

    15:20 | Contamination Control Strategy Development
    Kim Sobien, MBA, Senior Consultant-Microbiology, ValSource, Inc.

    The development and documentation of the contamination control strategy is viewed by many as the most difficult new requirement in the Annex 1 revision. This presentation will address how to fulfill this requirement, with a discussion on the expectations from regulators and practical advice derived from industry experience.

    15:40 | Day 2 Report Out, Q&A, and Panel Discussion

    16:25 | Closing Remarks from Workshop Co-Chairs
    Frederic B. Ayers, Senior Consultant, ValSource, Inc.
    Tracy Moore, Director, TM Pharma Group Ltd

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 new 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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Harris Conference Center

3216 CPCC Harris Campus Dr.
Charlotte, NC

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Registration Fees

Early Registration
Registration Type By 22 October
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 22 October
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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