Manufacturing, Supply Chain, and Inspections during the COVID19 Public Health Emergency August 25, 2021

Virtual | Virtual

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• Date: August 25, 2021

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Presentations	Speakers
Part 1 FDA guidance on manufacturing during COVID-19 and high absenteeism Questions and Panel Discussion	CDR Tara Gooen Bizjak Director Manufacturing Quality Guidance and Policy Staff | Office of Manufacturing Quality of Compliance | Office of Compliance | CDER | FDA CDR Emily Thakur, RPh Team Leader Drug Shortage Staff | CDER | FDA
Part 2 Risk management and application approaches in responding to supply chain constraints during PHE Questions and Panel Discussion	CDR Mahesh Ramanadham Associate Director of Scientific Operations Office of Pharmaceutical Manufacturing Assessment | Office of Pharmaceutical Quality | CDER | FDA Hasmukh Patel Director Division of Post-Market Activities 1 | Office of Lifecycle Drug Product Assessment | OPQ | CDER | FDA
Part 3 Inspections and use of alternate tools during the PHE Questions and Panel Discussion	Laurie Graham Director Division of Internal Policies and Procedures | Office of Policy for Pharmaceutical Quality | OPQ | CDER | FDA Derek Smith Deputy Director Office of Pharmaceutical Manufacturing Assessment | OPQ | CDER | FDA CDR Tara Gooen Bizjak Alonza Cruse Director Office of Pharmaceutical Quality Operations, Office Medical Products and Tobacco Operations, ORA, FDA Neil Stiber Associate Director Office of Quality Surveillance, OPQ | CDER | FDA

ABOUT THIS WEBINAR

Attendees for this webinar will hear the latest updates from FDA’s Center for Drug Evaluation Research (CDER) regarding policy and approaches toward manufacturing, supply chain, and inspections during the COVID19 Public Health Emergency (PHE).

Agenda

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TOPICS

• FDA guidance on manufacturing during COVID-19 and high absenteeism
• Risk management and application approaches in responding to supply chain constraints during PHE
• Inspections and use of alternate tools during the PHE

INTENDED AUDIENCE

• Quality unit leaders
• Quality and manufacturing personnel
• Regulatory affairs professionals who manufacture drugs for the US market (inclusive of application and non-application products)

FDA RESOURCES

• Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products
• Manufacturing, Supply Chain, and Drug and Biological Product Inspections During COVID-19 Public Health Emergency Questions and Answers
• Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency Guidance for Industry
• Good Manufacturing Practice Considerations for Responding to COVID-19 Infection in Employees in Drug and Biological Products Manufacturing
• Resuming Normal Drug and Biologics Manufacturing Operations During the COVID-19 Public Health Emergency
• FDA Resiliency Roadmap for FDA Inspectional Oversight