PASSING A US FDA GMP INSPECTION: A-Z Guaranteeing a Pass the First Time through an FDA Inspection

Areas Covered in the Webinar:

• FDA inspection objectives.
• FDA’s 21st-century initiatives and their impact on inspections:
  • Quality systems approaches and inspections
  • Risk management
  • Changes to FDA’s ONDC review process
  • Process and analytical technology (PAT)
  • Electronic records/electronic signatures (21CFR11)
• The approval process and how inspections are planned and triggered
• The differences between a GMP and a pre-approval inspection (PAI)
• Strategies of companies that have been successful; Lessons from companies that have failed
• Paying for an inspection
• Preparing for an inspection: key elements that must be covered
• Training your company staff
• How to handle an inspector
• Key do’s and don’ts: things that will kill you during an inspection
• What the inspector is looking for in:
  • Batch documentation
  • Stability studies
  • Validation documentation
• FDA’s inspection techniques: system inspections explained
• FDA strategies for PAI inspections
• FDA’s expectations from:
  • Your CAPA systems (Corrective Actions and Preventive Actions)
  • Your environmental trending reports
• What documents you need to show the FDA
• Effective investigation of:
  • Complaints
  • Out-of-specifications, out-of-trends
• Environmental monitoring requirements
• What to say (and what not to say) to an inspector
• The five validation inspections: what FDA looks for in validations
• Bribery, corruption, fraud: how to entertain FDA legitimately
• Documentation requirements: before, during and after the inspection
• Follow-up by FDA after an inspection
• FDA application integrity policy and import alert system
• Follow-up by the company after an inspection
  • What to say, and how to say it
  • Rescuing yourself from a marginal inspection

At the end of the course you will:

• Understand the mechanics and extent of an FDA inspection.
• Be fully aware of FDA’s risk management and quality systems approaches to GMP compliance.
• Realize how FDA’s 21st century GMP initiatives have changed the inspection landscape.
• Know how to prepare yourself and your company for an inspection.
• Recognize the traps and pitfalls facing you in an inspection.
• Know why you pass or fail an inspection in the first fifteen minutes.
• Understand why you absolutely cannot afford to fail an FDA inspection

Who will benefit:

• Senior management who will deal with FDA inspectors
• Regulatory affairs professionals and quality assurance personnel
• Production
• Engineering
• Validation
• Quality control and research and development staff who will be facing an FDA inspector will find this seminar essential preparation and key to the company’s success at the inspection.

Instructor Profile:

Michael Anisfeld, is senior consultant for Globepharm Consulting specializing in GMP/Quality activities for the healthcare manufacturing industries. In his current position he numbers among his clients United Nations Agencies, national regulatory agencies (including the US-FDA) and more than 200 pharmaceutical, medical device, biotechnology and bulk pharmaceutical companies in North America, Europe and Asia. Mr. Anisfeld has established and directed quality control, quality assurance, production and materials management functions in the industry. He has instituted innovative, cost-effective auditing Programmes for his clients, ensuring that they pass regulatory inspections the first time. With over twenty-five years expertise in the healthcare industry, Mr. Anisfeld has held senior management positions in international technology transfer, quality assurance, quality control and production.

In the course of his career, he has designed pharmaceutical, medical device and bulk pharmaceutical chemical facilities in seven countries. A member of the faculty of the University of Illinois, where he lectures in pharmaceutical technology, Mr. Anisfeld holds higher degrees in Pharmaceutical Technology (M.Sc.), Management (MSM) and Business Administration (MBA). An active member of many European and American regulatory and technical associations, he has served on the Board of Directors of the Parenteral Drug Association (PDA) and been chairman of its quality control and aseptic processing task groups. He currently serves on the FIP Task Force on Counterfeit Drugs and other international industry forums. An acclaimed international lecturer on the subject of GMP and quality topics, Mr. Anisfeld is also a prolific author on these subjects. He is the editor and author of many texts, including: International Drug GMPs, International Device GMPs, and Guide to FDA Pre-Approval Inspections, Sterile Pharmaceutical Manufacturing, and PDA’s monograph Validation of Aseptic Processing of Liquid Drug Products.

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