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The 2021 PDA Pharmaceutical Manufacturing & Quality Virtual Conference will continue on the theme of PDA APAC 2020 conference and will provide an update on the evolving landscape of GMP regulations, in particular Annex 1 requirements. Of particular interest is the inclusion of PUPSIT in Annex 1 including its on-going debate on the interpretation and implementation. We will also touch on key trends in barrier technology in sterile manufacturing as well as quality control microbiology including rapid microbiology, which is of increasing interest in delivering speed for COVID-19 vaccine manufacturing and the growing segment of cell and gene therapy.


Presentations will include topics on:

  • Regulatory and compendial updates
  • Implementation of Annex 1 and PUPSIT in sterile manufacturing
  • New technology in aseptic processing
  • Contamination Control Strategy
  • Environmental Monitoring and Rapid Microbiological Methods

2021 PDA Cleanroom Qualification: Current Regulatory Expectation

As an extension to this conference, PDA is proud to present a workshop on Cleanroom Qualification: Current Regulatory Expectation happening on Friday, 17 September 2021.


For more information, visit https://bit.ly/PDACleanRoomWorkshop​

Speakers

Ziva Abraham

CEO of Microrite

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Peter Baker

Vice President at Green Mountain Quality Assurance LLC

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Hal Baseman

Chief Operating Officer at Valsource Inc

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Lisa Bennett

Senior Quality & Compliance Specialist at Cell Therapies

Li Wei Chan

Manager, Microbiology at MSD International GmbH

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Olivier Chancel

Quality Auditor, Sterility Assurance Expert at Boehringer Ingelheim

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Emily Cheah

Managing Director of Charles River Laboratories (Singapore)

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Rick Friedman

Deputy Director, Office of Manufacturing Quality at US FDA

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Agenda

Welcome Address
SESSION 1: Regulatory Landscape and Trends
Sterile Drug Products: Microbiological Contamination Risk Considerations
Updates on Regulatory Inspections in Singapore
Panel Discussion and Q&A
SESSION 3: Aseptic Processing Challenges in the Context of Annex 1
The implications of PUPSIT in Annex 1 revision
Sterile Filtration Quality Risk Management Collaboration and PUPSIT Failure Survey
Points to consider for line design and implementation of Pre-Use Post Sterilization Integrity Test (PUPSIT)
Panel Discussion and Q&A
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Sponsors and Partners