How to Survive FDA's 'New' Inspection and Enforcement Practices 2012

Key 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.