Managing Domestic and Foreign FDA Inspections and the COVID-19 Impact is an event dedicated to the factors used by the FDA to schedule inspections. You will learn how to predict what an FDA investigator will do .
Managing Domestic and Foreign FDA Inspections and the COVID-19 Impact covers topics such as:
- Over products
- FDA legal authority to inspect
- Scientific/clinical studies
- Over firm’s
- Postmarket requirements
- Premarket requirements
- Inspection Procedures
- FDA’s annual inspection work plan
- FDA Training
- FDA inspection Manuals
- Refusals
- Documenting violations
- Recall procedures (What FDA expects from you.)
- Human factors
- FDA Center(s) Management
- FDA Field Office Management
- Inspectional observations (Form FDA-483)
- The firm’s job
- Responding to a Warning Letter
- Responding to a 483
- Follow up inspections
- FDA enforcement actions
- Foreign Inspections
Managing Domestic and Foreign FDA Inspections and the COVID-19 Impact intended for:
- Quality Assurance Managers
- Regulatory Affairs Directors
- Manufacturing Directors and Managers
- Quality Control Managers
- Venture Capitalists
- Product Risk Managers