Topics
- Recent changes: summary and details
- Inspection process for API, drug manufacturing and device manufacturing
- Strategy to respond to the `New` type of inspections
- Examples of recent observations/deviations that came as a surprise
- Preparing your staff for the `New` FDA inspections
- Case study: Going through a typical inspection process
- Tips how to respond during inspections to avoid inspectional observations
- Conducting `FDA inspection like` internal audits
- Developing a corrective action plan with identification of the root case
- The role of the Exit Meeting to avoid enforcement
- How to use all this information for all national and international inspections
- Developing a detailed preventive action plan to avoid reoccurrence
Who should Attend
QC directors, QA managers and personnel, Regulatory affairs, Analysts and lab managers, Training department, Internal auditors, Consultants and Documentation department.
