2022 PDA Annex 1 Workshop (Dallas)
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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.
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
Agenda highlight: Select sessions will be followed by interactive breakout group discussions focused on implementation!
Health and Safety
The safety and wellbeing of our participants is a top priority for PDA; therefore, we will be implementing the following guidelines for this in-person event:
Vaccination Requirement
Participants, including attendees, exhibitors, trainers, students, staff, guests, contractors, and vendors, must provide proof of vaccination after registering for an in-person event. Accommodation may be offered on a case-by-case basis for any in-person participant who is unable to be vaccinated due to disability or medical condition, or in connection with a sincerely held religious belief or practice, unless otherwise provided under applicable state or local law. Accommodation requests must be made no later than 18 March 2022.
For those registered for the in-person meeting, you will receive a link to upload and verify your vaccine status in early 2022.
Participants that are unable to meet the vaccine requirement or fail to get a PDA-approved accommodation request will not be granted admittance to the event.
Mask Requirement
If mandated by national, state, or local guidelines in effect during the dates of any meeting, PDA will require masks to be worn indoors regardless of vaccination status.
Additional Requirements
PDA will be making decisions on additional precautionary measures closer to the date of the event and in accordance with the latest CDC guidance, local requirements, and hotel policies.
Agenda
Discover What's Happening Each Day
Thursday, 07 April
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08:00 – 09:30 | P1: Overview of and Revision Process for Annex 1 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. |
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08:00 – 08:20 | Welcome Remarks from Workshop Co-Chair 08:20 – 08:40 | Industry Perspective 08:40 – 09:00 | Regulatory Perspective 09:00 – 09:30 | Q&A |
09:30 – 10:00 | Break
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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 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. |
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10:00 – 10:20 | Using Quality Risk Management to Enable the Contamination Control Strategy 10:20 – 10:40 | Contamination Control Strategy Development 10:40 – 11:00 | Considerations of Annex 1 for Advanced Therapy Medicinal Products and Low Bioburden Products |
11:00 – 11:05 | Transition into Breakout Groups
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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
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13:00 – 14:00 | P3: Premises and Barrier Systems 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. |
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13:00 – 13:20 | Cleanroom Design: Classification, Qualification, Air Visualization 13:20 – 13:40 | Cleanroom Operation: Disinfection, Transfer of Materials, Monitoring 13:40 – 14:00 | Barrier Technologies: RABS and Isolators, Glove Integrity, Robotics, Decontamination |
14:00 – 14:05 | Transition into Breakout Groups
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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
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15:30 – 16:30 | P4: Equipment, Technology, and Utilities 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. |
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15:30 – 15:50 | Decontamination and Sterilization of Direct and Indirect Product Contact Surfaces 15:50 – 16:10 | Water Systems and Other Critical Utilities 16:10 – 16:30 | Q&A |
16:30 – 16:35 | Transition into Breakout Groups
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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
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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 EM data can provide critical feedback on individual operator performance, potential routes of contamination, specific gowning procedures and overall training efficacy. |
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08:00 – 08:20 | Day 1 Report Out 08:20 – 08:40 | Qualification and Training 08:40 – 09:00 | Gowning, Personnel Monitoring, and Beyond |
09:00 – 09:05 | Transition into Breakout Groups
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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
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10:15 – 11:15 | 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 types of sterilization and the parameters needed to demonstrate successful sterilization. |
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10:15 – 10:45 | Aseptic Processing 10:45 – 11:15 | Filtration and Pre-Use Post Sterilization Integrity Testing |
11:15 – 11:20 | Transition into Breakout Groups
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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
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13:00 – 13:40 | P7: Production Technologies, Part 2 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. |
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13:00 – 13:20 | Container Closure Integrity Testing and Finishing 13:20 – 13:40 | Production and Specific Technologies (Blow-Fill-Seal, Lyophilization, Single Use System, and Terminal Sterilization) |
13:40 – 13:45 | Transition into Breakout Groups
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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
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15:00 – 16:30 | P8: Aseptic Process Simulation and Environmental Monitoring 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. |
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15:00 – 15:20 | Environmental and Process Monitoring 15:20 – 15:40 | Aseptic Process Simulations 15:40 – 16:10 | Q&A and Final Panel Discussion 16:10 – 16:30 | Day 2 Report Out |
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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.
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.
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
Registration
Pricing Options
Standard Registration
Member Price
$2,195Early Career ProfessionalMember Only
$1,095
Non-Member
$2,495
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 registration@pda.org.
Sponsor information will be available soon
We're currently finalizing our list of sponsors and will share the details shortly.
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