Cathy Burgess will speak at this conference hosted by the American Conference Institute. Her session is titled “Responding to the Latest FDA Inspection and Enforcement Activity” and will cover:
- Investigating recent trends in OTC drug manufacturing inspections
- Anticipating and preparing for both unannounced and routine inspections by FDA
- Preparing for a paper inspection vs. an in-person inspection from FDA
- Examining how new FDA inspection tools and remote regulatory assessments may help to increase inspection efficiencies
- Shedding light on the latest areas of focus for FDA enforcement
- Examining the latest wave of FDA warning letters issued to OTC drug manufacturers regarding GMP issues – what trends are we seeing and what are the implications?
- Examining the role of compliance and ingredient transparency in shaping OTC products’ market presence
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