$0 – $69

Actions and Detail Panel

$0 – $69

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Event description
Participate in sessions with distinguished speakers from the pharmaceutical industry and FDA on regulatory, compliance, and quality topics

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Program

10:00 AM – 10:10 AM Welcome and Opening Remarks - Sonande A. Shah, Associate Director, Global Strategy Change and Continuous Improvement in Cell Therapy, Bristol Myers Squibb

and Michael Spangler, Principal Consultant, Spangler Consulting LLC

10:10 AM – 10:30 AM Inspection Trends Helen Verdel, Drug Specialist, Investigator Consumer Safety Officer, NJ FDA

10:30 AM – 11:00 AM Application of Quality Risk Management, the Challenges & Opportunities Monika Bagga, Associate Director, Quality Risk Management, Bristol Myers Squibb

11:00 AM – 11:10 AM Break

11:10 AM – 11:40 AM Overseas inspections Adetutu Gidado, Drug Specialist, Investigator Consumer Safety Officer, NJ FDA

11:40 AM – 12:10 PM Remote/Virtual Audits Peter Smith, Principal Consultant, Smith Consulting Group

12:10 PM – 12:40 PM Break

12:40 PM – 01:10 PM KASA: Opportunity for Modernizing Regulatory Assessment and Submission Lawrence Yu, Director Office of New Drug Products, FDA

01:10 PM – 02:00 PM Q & A Panel Discussion and closing remarks


		2021 NJPQCA/FDA Conference image

		2021 NJPQCA/FDA Conference image
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