If you’re in the business of manufacturing drugs, medical devices, nutraceuticals, or manufacturing or importing any product in the United States that falls under current Good Manufacturing Processes (cGMP) regulations, your facility will be inspected by the U.S. Food and Drug Administration (FDA). This presentation will get you ready for an FDA inspection which includes: Task to complete before an unannounced inspection, conducting a regulatory agency inspection, and after the inspection.
Preparation Before an inspection
During an Inspection
After the Inspection
Topics covered include:
This webinar will provide valuable assistance to all personnel in:
Physical CD-USB of recorded session will be despatched after 72 hrs on completion of payment
elicia Angus is passionate quality professional with over 23 years of pharmaceutical experience in the clinical, solid dosage, API, sterile and biological industries and over 6 years of vendor management experience. As a Supplier Relations Team Leader, Felicia is passionate about quality and ensuring every individual at a manufacturing site is prepared for any situation. She is a subject matter expert in executing and monitoring compliance to FDA, EMA, DEA, Canadian, Japanese, Swedish, and ICH and 21CFR820 regulatory requirements. Felicia Angus is the CEO of Quality Culture Champions, LLC ensuring a positive quality culture is embedded into any organizations.