FDA Regulated Industries 2021 - Dealing with CAPA- Corrective and Preventive Actions in FDA Regulated Industries

CAPA ( Correcive and Preventive Actions) for FDA regulated arena such as Medical Device, Food and Pharmaceutical industries is getting a lot of attention today by FDA and ISO auditors. CAPA requirements have been tightened for ISO 13485
To understand and fulfill the ever growing, complex CAPA requirements for the FDA regulated Medical Device, Food and Pharmaceutical industries when non conformance happens in the quality systems at any point during product manufacturing and shipment.
Will review FDA CAPA definitions and expectations based on her personal experience in closing several CAPAs in FDA regulated industries
Will incorporate several examples based on the FDA CAPA Requirements so you can integrate them into your product risk management for commercialization
Speaker:
Meena Chettiar, has worked as a Scientist for Health Canada and as a Quality Management Professional in food, pharmaceutical and medical device industries for over 25 Years in Canada and the United States.