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
Last Recorded Date: Oct-2011

Training CD / USB Drive

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

Customer Care

Fax: +1-650-362-2367


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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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

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