The COVID-19 pandemic has impacted the biopharmaceutical industry and regulatory agencies on many different fronts. More specifically the ‘Nuts and Bolts’ session will review the impact of the pandemic on manufacturing & supply chain continuity, new technologies that are being explored to mitigate pandemic related constraints, routine quality management topics including internal and health authority interactions. This session will also introduce how regulatory agencies are responding to new challenges through the example of the FDA.
• The impact of the pandemic on manufacturing operations - how to maintain complex supply chain continuity with a workforce that is now working from home, may be sick or carriers of the virus. Manufacturing operations may be further challenged with limitations in some raw materials, supply constraints resulting from transportation disruptions. • The impact of the pandemic on use and further development of digital technologies enabling the daily operation and interactions with regulatory agencies. • The impact of the pandemic on the biopharmaceutical manufacturers' 'license to operate' - how to remain compliant with regulatory expectations to get approval of new products and meet growing market demands for commercial products, how bio manufacturers have set themselves up for virtual inspections and other virtual compliance routines. • Impact of the pandemic on FDA - how inspections are dealt with during the pandemic with the inability to travel, paper review or acceptance of other agencies conclusions in lieu of inspections, virtual inspections, risk -based approach for pre-approval and pre-license inspections, etc.