Preparation for GMP Inspections by Regulatory Agencies - 2017

This webinar will provide practical tips and advice for ensuring that all inspections are conducted in the most effective and efficient way possible, including ongoing readiness for inspections, rehearsals and preparation for successful facility inspections, and response to findings by regulatory agencies.

Why should you Attend:

Good manufacturing practice (GMP) is the minimum standard that a manufacturer must meet in their production processes.

This webinar will review what to expect during the Agency inspection and how to successfully and efficiently streamline and manage the inspection, including adequate follow-up during and after the inspection.

Areas Covered in the Session:

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

Who Will Benefit:

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