Preparation for GMP Inspections by Regulatory Agencies - 2017

Topics

• Notification Timing
• Types of Inspections (for cause, pre-approval, periodic ) - API & FDF
• What to expect during Inspection
• Foreign Facilities
• Make adjustments as needed/address issues/take needed actions
• Do a company audit as the FDA would (fall dress rehearsal)
• Inspection on follow-up
• Managing the Inspection

Who should Attend

• Manufacturing
• Design Engineers
• Technical operations
• Supply chain
• Quality assurance
• Quality control