FDA Validation Requirements - A Primer

Instructor: Martha Bennett 
Product ID: 702048
Training Level: Basic to Intermediate
  • Duration: 90 Min

recorded version

1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section

Training CD

One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-565-8542


Read Frequently Asked Questions

This FDA Validation Requirements training will focus on validation terminology, structure for a validation program, the elements (DQ, IQ, OQ, PQ, PV), validation of analytical methods and automated systems, and CGMP requirements.

Why Should You Attend:

Validation is the cornerstone of control over the manufacture and processing of many FDA-regulated products and is a CGMP requirement for drugs, biologics, and medical devices.

This course is intended to introduce the participants to validation terminology, structure of a validation program, and the basic contents of design qualification, installation qualification, operation qualification, performance qualification, process validation, analytical methods validation, equipment cleaning validation, and the validation of automated systems.

Learning Objectives:

  • Understanding of validation terminology.
  • Understanding of structure for a validation program and validation master plan.
  • Understanding of elements of DQ, IQ, OQ, PQ, PV, and the validation of analytical methods, equipment cleaning methods, and automated systems.
  • Understanding of CGMP requirements.

Areas Covered in the Seminar:

  • Validation terminology.
  • Validation master planning.
  • Design qualification.
  • Installation qualification.
  • Operation qualification.
  • Performance qualification.
  • Process validation.
  • Equipment cleaning validation.
  • Analytical methods validation.
  • Automated systems validation.
    • Part 11 compliance.
  • CGMP requirements.

Who Will Benefit:

  • All FDA regulated companies
  • 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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