Preparing for an FDA Pre-Approval Inspection

Why Should You Attend:

FDA pre-approval inspections are a critical and integral part of the approval process for drugs, biologics, and medical devices.

This course is designed to teach participants about the development of this inspection program, its purpose and scope, how they are conducted, and suggest practical steps to ensure success. Regulatory consequences from inspection results will also be covered.

Learning Objectives:

• History behind FDA pre-approval inspections.
• Purpose of FDA pre-approval inspections.
• Scope of FDA pre-approval inspections.
• Consequences of FDA pre-approval inspections.
• Keys to a successful FDA pre-approval inspection.

Areas Covered in the Seminar:

• History behind FDA pre-approval inspections.
  • Incidents and behavior resulting in program of pre-approval inspections.
• Purpose of FDA pre-approval inspections.
  • Summary of FDA internal inspection procedures.
  • Summary of FDA internal pre-approval inspection procedures.
• Scope of FDA pre-approval inspections.
  • Human and animal drugs, biologics, medical devices.
  • Records.
• Consequences of FDA pre-approval inspections.
  • Recommendations for approval or non-approval.
  • Application Integrity Policy.
  • Criminal consequences.
  • Disqualification.
• Keys to a successful FDA pre-approval inspection.
  • Quality systems.
  • Preparation of pre-market submissions (NDA, NADA, ANDA, ANADA, BLA, PMA).
  • Preparation for FDA inspections.
  • Response to FDA inspections.

Who Will Benefit:

• Manufacturers of drugs (human and veterinary), biologics, medical devices
• Quality professionals
• Regulatory affairs professionals

Instructor Profile:

Martha M. Bennett , RAC, provides a variety of regulatory affairs and quality system (GxP) consulting services to FDA regulated companies worldwide, covering foods, drugs and biologics, medical devices, and cosmetics. Based on almost forty years of experience within and outside of FDA, Martha assists companies with compliance, product development and approval, and post-marketing issues. Using risk management tools, (e.g., Six Sigma, FMEA, HACCP), Martha assists companies with validation strategy, planning and execution. Martha conducts FDA and quality focused audits and training. Thoroughly grounded and experienced in FDA law and regulations, Martha also provides consulting services to legal teams as well as expert testimony.

Martha was an FDA field investigator, senior compliance officer, and policy analyst for three FDA Commissioners. She is a board member for ASQ-FDC (American Society for Quality – Food, Drug & Cosmetic Division) and SQA (Society of Quality Assurance – Education Committee). Based on her experience and contribution to the profession, she was named a RAPS Senior Fellow.

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