
2023 PDA Annex 1 Workshop (Raleigh)
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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.
At the completion of this workshop, participants will be able to:
- Gain awareness of the requirements and changes in Annex 1 and move towards compliance with the proposed changes in the revision
- Develop strategies for implementation and verification of the Annex 1 requirements, respectively, for their organizations
Program Highlights
The 2023 PDA Annex 1 Workshop (Raleigh) is sold out! To be added to the wait list, please email [email protected].Agenda
Discover What's Happening Each Day
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 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 08:20 | Regulatory Perspective 08:40 | Insights from a Former Regulator |
09:30 – 10:00 | Break in Exhibit Area
10:00 – 11:00 | P2: Scope, Principles and Pharmaceutical Quality Systems 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 10:20 | Contract Manufacturing Organizations 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 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 13:20 | Cleanroom Operation: Disinfection, Transfer of Materials, Monitoring 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 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 15:35 | Decontamination and Sterilization of Direct and Indirect Product Contact Surfaces 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 |
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 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 08:20 | Qualification and Training 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 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 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 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 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 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 15:20 | Contamination Control Strategy Development 15:40 | Day 2 Report Out, Q&A, and Panel Discussion Frederic B. Ayers, Research Scientist, Eli Lilly and Company Tracy Moore, Director, TM Pharma Group Ltd |
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Venue Details and Accommodations
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 StreetRaleigh, NC

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:
How to Get Here
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Pricing Options
Standard Registration
Member Price
$2,495GovernmentMember Only
$895
Health AuthorityMember Only
$895
Early Career ProfessionalMember Only
$1,395
StudentMember Only
$595
AcademicMember Only
$895
Non-Member
$2,895
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].
Sponsor information will be available soon
We're currently finalizing our list of sponsors and will share the details shortly.
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