Preparation for GMP Inspections by the FDA
Duration : 90 Minutes
Peggy J Berry,
Peggy J. Berry, MBA, RAC, is the President & CEO at Synergy Consulting where she provides consulting services to companies in all aspects of drug development. She also provides group and one-on-one training in drug development, regulatory affairs and project management topics. Prior to founding Synergy Consulting in 2015, Read more
Regulatory agencies conduct product-related GMP inspections when assessing an application for marketing approval. Pre-approval inspections check that the manufacturer complies with GMP principles and practices from ICH and the local region. Following approval, routine follow-up inspections will do.
Product-related inspections may also be conducted if the agency is informed or suspects a possible GMP breach. This may be triggered by a whistle blower, an inspection for other products manufactured in the facility, or inspections conducted by other regulatory authorities.
Inspections may be announced or conducted spontaneously. 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.
You will also learn what SOPs should be in place for inspections and the content of each.
Course Objectives:
Good manufacturing practices (GMPs) are the minimum standard that a manufacturer must meet in their production processes. Products must:
• Be of consistently high quality
• Be appropriate to their intended use
• Meet the requirements of the marketing application and product specifications
Regulatory agency inspections can be difficult to prepare for and manage. This webinar will review what to expect during the Agency inspection so that you can successfully and efficiently prepare and manage the inspection. Learn to respond to questions during the inspection and how to prepare documents that may be requested. And, providing apprappropriatelow-up aftr the inspection.
Course Outline:
• Types of Inspections (for cause, pre-approval, periodic
• Drug Substance & Drug Product
• Notification timing
• Foreign facilities
• What to expect during inspection
• Do a company audit as the FDA would
• Make adjustments as needed/address issues/needed actions
• Managing the inspection
• Inspection follow-up
What You Get:
• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points
Who Will Benefit:
The following professionals from all FDA regulated industries will benefit from this training:
• Design Engineers
• Manufacturing
• Supply chain
• Technical operations
• Quality control
• Quality assurance
• Regulatory affairs
Please reach us at 1-888-844-8963 for any further assistance or if you wish to register
