The deliverables identified by the task force include:
- Industry Survey on Impact of COVID-19 to Manufacturing Operations.
(Action completed, link below)
- Initial Publication on COVID-19 covering the virus and specific areas that should be considered related to manufacturing operations.
- Webinars specific to consideration for manufacturing and supply chain operations.
- May 27, 2020 - Impact of the COVID-19 Pandemic on the Pharmaceutical Supplu Chain (Basic Overview)
- June 29, 2020 - Remote Assessments and Inspections during the COVID-19 Pandemic: Regulator Perspectives (View Slides) (June 29 Webinar Notes)
- July 30, 2020 - Remote Assessments and Inspections during the COVID-19 Pandemic: Industry Perspectives (View Slides)
- August 24, 2020 - Applying the new June 2020 FDA Guidance on Responding to COVID-19 Infection in Employees in Manufacturing (View Slides)
- September 23, 2020 - Utilization of Modular Manufacturing to Enhance/Upscale Capacity During Covid-19 (View Slides)
- Commenting on new and existing regulatory guidance as well as proposing were new guidance may be needed.
PDA Regulatory Response on COVID-19
- Development of a PDA Points to Consider document focused on preparing for and responding to a pandemic in regards to manufacturing and supply chain operations.