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2022 PDA Annex 1 Workshop

2022 PDA Annex 1 Workshop (Dallas)

Apr 07 - Apr 08, 2022
Dallas, TX

  • Workshop
  • The Americas

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Program Highlights

Agenda highlight: Select sessions will be followed by interactive breakout group discussions focused on implementation!

Overview

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 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.

Agenda

  • Day 1
  • Day 2
  • Thursday, 07 April

    08:00 – 09:30 | P1: Overview of and Revision Process for Annex 1
    Moderator: Hal Baseman, MBA, Chief Operating Officer, ValSource Inc.

    Over the past four years, the new 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 contains a significant amount of new and more detailed content on many topics. It places a heightened emphasize the use of risk based assessment and approaches to design and evaluate manufacturing contamination control. This session will provide insights from both the regulatory authorities and industry experts involved in the Annex development and review process of the revision, with a focus on the evolution, planning, and implementation of these changes.

    08:00 – 08:20 | Welcome Remarks from Workshop Co-Chair
    Gabriele Gori, Site Quality Head, ThermoFisher Scientific

    08:20 – 08:40 | Industry Perspective
    Hal Baseman, MBA, Chief Operating Officer, ValSource Inc.

    08:40 – 09:00 | Regulatory Perspective
    Tracy Moore, Business Director & Senior Consultant, ExPharmaceutical Inspectors Consortium Ltd

    09:00 – 09:30 | Q&A

    09:30 – 10:00 | Break

    10:00 – 11:00 | P2: Scope, Principles and Pharmaceutical Quality Systems
    Moderator: Alan E. Dake, Lead Auditor, Merck & Co., 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 tracks through all other sections. This session 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 – 10:20 | Using Quality Risk Management to Enable the Contamination Control Strategy
    Amanda M. McFarland, BS, Senior Consultant, ValSource Inc.

    10:20 – 10:40 | Contamination Control Strategy Development
    Cheryl E. Essex, MS, Head of Quality Operations R&D Genomic Medicines, Sanofi

    10:40 – 11:00 | Considerations of Annex 1 for Advanced Therapy Medicinal Products and Low Bioburden Products
    Biswarp Dasgupta, MS, Quality Professional

    11:00 – 11:05 | Transition into Breakout Groups

    11:05 – 12:00 | Breakout Session 1

    Sessions over the two days of the workshop will include presentations of principal changes to Annex 1, followed by a small break out group discussion targeting hot topics discussed during the Q&A segments.

    12:00 – 13:00 | Lunch Break

    13:00 – 14:00 | P3: Premises and Barrier Systems
    Moderator: Marcia C. Baroni, MBA, VP Quality Operations, Emergent BioSolutions

    Aseptic manufacturing facilities come in a variety of shapes and sizes, from traditional aseptic through 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 new Annex 1.

    13:00 – 13:20 | Cleanroom Design: Classification, Qualification, Air Visualization
    Alan E. Dake, Lead Auditor, Merck & Co., Inc.

    13:20 – 13:40 | Cleanroom Operation: Disinfection, Transfer of Materials, Monitoring
    Donald C. Singer, MA, Senior Microbiology Technical Consultant, North America, Ecolab Life Sciences

    13:40 – 14:00 | Barrier Technologies: RABS and Isolators, Glove Integrity, Robotics, Decontamination
    Richard Denk, Senior Consulting Aseptic Processing & Containment, SKAN AG

    14:00 – 14:05 | Transition into Breakout Groups

    14:05 – 15:00 | Breakout Session 2

    Sessions over the two days of the workshop will include presentations of principal changes to Annex 1, followed by a small break out group discussion targeting hot topics discussed during the Q&A segments.

    15:00 – 15:30 | Break

    15:30 – 16:30 | P4: Equipment, Technology, and Utilities
    Moderator: Richard Denk, Senior Consulting Aseptic Processing & Containment, SKAN AG

    Aseptic manufacturing facilities, in particular, of equipment design and critical Utilities as water system are discussed in this session. The new Annex 1 created a lot of discussion about indirect product contact parts as stopper bowls but also on the new section about utilities. This session will cover the impact of the Annex 1 revision on equipment design and utilities.

    15:30 – 15:50 | Decontamination and Sterilization of Direct and Indirect Product Contact Surfaces
    Marcia C. Baroni, MBA, VP Quality Operations, Emergent BioSolutions

    15:50 – 16:10 | Water Systems and Other Critical Utilities
    Biswarp Dasgupta, MS, Quality Professional

    16:10 – 16:30 | Q&A

    16:30 – 16:35 | Transition into Breakout Groups

    16:35 – 17:30 | Breakout Session 3

    Sessions over the two days of the workshop will include presentations of principal changes to Annex 1, followed by a small break out group discussion targeting hot topics discussed during the Q&A segments.

    17:30 – 18:30 | Networking Reception

  • Friday, 08 April

    08:00 – 09:00 | P5: Personnel Training, Qualification, Gowning, and Monitoring/Assessment
    Moderator: Marc Glogovsky, MS, S.M. (NRCM), 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 EM data can provide critical feedback on individual operator performance, potential routes of contamination, specific gowning procedures and overall training efficacy.

    08:00 – 08:20 | Day 1 Report Out
    Hal Baseman, MBA, Chief Operating Officer, ValSource Inc.

    08:20 – 08:40 | Qualification and Training
    Marcia C. Baroni, MBA, , VP Quality Operations, Emergent BioSolutions

    08:40 – 09:00 | Gowning, Personnel Monitoring, and Beyond
    Cheryl E. Essex, MS, Head of Quality Operations R&D Genomic Medicines, Sanofi

    09:00 – 09:05 | Transition into Breakout Groups

    09:05 – 09:45 | Breakout Session 4

    Sessions over the two days of the workshop will include presentations of principal changes to Annex 1, followed by a small break out group discussion targeting hot topics discussed during the Q&A segments.

    09:45 – 10:15 | Break

    10:15 – 11:15 | P6: Production Technologies, Part 1
    Moderator: Amanda M. McFarland, BS, 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 types of sterilization and the parameters needed to demonstrate successful sterilization.

    10:15 – 10:45 | Aseptic Processing
    Frederic B. Ayers, Research Scientist, Eli Lilly and Company

    10:45 – 11:15 | Filtration and Pre-Use Post Sterilization Integrity Testing
    Maik W. Jornitz, MSEng, CEO, G-CON Manufacturing, Inc.

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

    11:20 – 12:00 | Breakout Session 5

    Sessions over the two days of the workshop will include presentations of principal changes to Annex 1, followed by a small break out group discussion targeting hot topics discussed during the Q&A segments.

    12:00 – 13:00 | Lunch Break

    13:00 – 13:40 | P7: Production Technologies, Part 2
    Moderator: Hal Baseman, MBA, Chief Operating Officer, ValSource Inc.

    This section will introduce some of the more intriguing topics covered and expanded in the revised Annex. The topics were selected based on input from the sterile product manufacturing community, as noted during prior meetings and discussions. There will be an emphasis on changes and challenges of implementing the Annex 1 recommendations on these topics.

    13:00 – 13:20 | Container Closure Integrity Testing and Finishing
    Oliver P. Stauffer, MBA, CEO, Packaging Technologies & Inspection LLC

    13:20 – 13:40 | Production and Specific Technologies (Blow-Fill-Seal, Lyophilization, Single Use System, and Terminal Sterilization)
    Patrick Poisson, EVP, Technical Operations, United Therapeutics Corp.

    13:40 – 13:45 | Transition into Breakout Groups

    13:45 – 14:30 | Breakout Session 6

    Sessions over the two days of the workshop will include presentations of principal changes to Annex 1, followed by a small break out group discussion targeting hot topics discussed during the Q&A segments.

    14:30 – 15:00 | Break

    15:00 – 16:30 | P8: Aseptic Process Simulation and Environmental Monitoring
    Moderator: Cheryl E. Essex, MS, Head of Quality Operations R&D Genomic Medicines, Sanofi

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

    15:00 – 15:20 | Environmental and Process Monitoring
    Marc Glogovsky, MS, S.M. (NRCM), Senior Consultant – Microbiology, ValSource, Inc.

    15:20 – 15:40 | Aseptic Process Simulations
    Gabriele Gori, Site Quality Head, ThermoFisher Scientific

    15:40 – 16:10 | Q&A and Final Panel Discussion
    Hal Baseman, MBA, Chief Operating Officer, ValSource Inc.

    16:10 – 16:30 | Day 2 Report Out
    Hal Baseman, MBA, Chief Operating Officer, ValSource Inc.

Highlighted Speakers

Biswarup DasGupta
Biswarup DasGupta
Quality Professional
Richard  Denk
Richard Denk
SKAN AG
Cheryl E. Essex
Cheryl E. Essex
Sanofi
Marc Glogovsky
Marc Glogovsky
Valsource, Inc.
Maik W. Jornitz
Maik W. Jornitz
G-CON Manufacturing, Inc.
Amanda McFarland
Amanda McFarland
ValSource, Inc.
Patrick Poisson
Patrick Poisson
United Therapeutics Corp.
Donald C. Singer
Donald C. Singer
Ecolab Life Sciences

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.

Hyatt Regency Dallas

300 Reunion Boulevard
Dallas, TX
Phone: +1 (214) 651-1234

Make a Reservation
Hyatt Regency Dallas
  • Accommodations

    A block of rooms have been reserved for meeting participants at the Hyatt Regency Dallas. The rate is $249 for single or double occupancy. Guestroom rates are subject to discounted resort fee ($20 per night) and State and Local taxes.

    Reservations must be secured by Friday March 4, 2022. After this date, reservations can be made on a space-and-rate available basis only. Check-in time is 4:00 p.m.; check-out time is 11:00 a.m.

    To make reservations, individuals may click on the reservation link above or call the Hyatt Regency Dallas at +1 (214) 651-1234. Be sure to tell the reservationist that you are with the PDA Meeting to receive the PDA group rate.

    Individual Cancellation

    Please be aware that obtaining and canceling hotel reservations is the responsibility of the meeting registrant. Individuals will be responsible for payment of their own cancellation fees. The cancellation policy is 3 days in advance of arrival date, unless otherwise specified on your reservation information.

  • Amenities

    Located downtown next to an iconic Dallas landmark Reunion Tower, Hyatt Regency Dallas is a gateway to the best of the city. Live, work and be yourself at our inviting, contemporary hotel near the Dallas Convention Center and within walking distance of many tourist attractions, including Dealey Plaza and the Historic West End. Whether you are here to work or play, Hyatt Regency Dallas is designed to meet all of your needs.

How to Get Here

By Air

Dallas/Fort Worth International Airport (DFW) is approximately 20 miles from the Hyatt Regency Dallas and all major carriers service this airport. Dallas Love Field Airport (DAL) is approximately 7 miles from the Hyatt Regency Dallas. Alaska Airlines, Delta and Southwest service this airport. Taxi fares from DFW are approximately $45-50 one way, not including tip. Taxi fares from DAL are approximately $20-25 one way, not including tip. App based rides are available to/from the airport.

By Car

The Hyatt Regency Dallas is located at 300 Reunion Boulevard, Dallas, TX 75207. Valet Parking, operated by PMSI, is available at hotel entrance. In and out privileges for hotel guests only. Self-parking in the outdoor Radish Lot is conveniently located on the north end of the hotel at the intersection of Hotel Street and Reunion Boulevard West. In and out privileges for overnight guests only, operated by PMSI. Self Parking Overnight Guests Includes in & out privileges Daily Guest & Reunion Tower $19 Radish Lot, 0–4 hours | $9 Radish Lot, 4–8 hours | $13 Radish Lot, 8-24 hours | $19 B-Lot, 0–4 | $7 B-Lot, 4–8 hours | $13 B-Lot, 8-24 hours | $19 Valet Parking Overnight Guests |$32 + tax 0–4 hours | $22 4–8 hours| $26 8–24 hours | $32

Other Options

Amtrak: Connected to Hyatt Regency Dallas by way of underground walkway to Union Station. Please call 214 653 1101 for train information. Greyhound: The nearest Greyhound station is located at 205 S Lamar St. Please call 214 849 6831 for bus information. DART Light Rail Service: the hotel is conveniently connected to Union Station on the Red and Blue lines and is also a stop for TRE commuter rail to Fort Worth. Dallas Streetcar: This is a FREE service provided by DART that picks up at Union Station, connected to the hotel, and runs to the Bishop Arts District, one of Dallas' best areas for food, shops and galleries.

Directions

Registration Fees

Regular Price
Registration Type Early Registration After 06 February
Member $1,695 $2,195
Non-Member $1,995 $2,495
Govern./Health Authority/Academic (Member/Non-Member) $700 $700
Student (Member/Non-Member) $350 $350
Early Career Professional (Member Only) $1,095 $1,095

* 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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