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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.

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