S-09. Validation and Qualification Compliance Requirements

Course Description

This course reviews the GMP compliance requirements for validation and qualification, and the latest FDA interpretations of these GMP requirements and issues. This course also reviews current compliance issues, such as revalidation and requalification, qualification of existing equipment, and provisions for validation/qualification matrixing and bracketing. The topics for review and discussion include process validation, installation and operation qualifications, validation documentation, cleaning validation and computer validation.

Learning Objectives

The objectives of this course are to provide the attendees with an updated review of the latest GMP requirements and FDA interpretations for validation and qualification, and practical recommendations for the most effective and efficient methods to achieve a satisfactory level of compliance.

Who Should Attend

This course is suitable for professionals with a basic or advanced knowledge of GMP/FDA requirements and compliance issues for validation and qualification. The course will benefit Quality professionals with responsibility for validation compliance and auditing; and Validation, Engineering and Production professionals with responsibilities for the execution of the validation/qualification, and the preparation of related records.

Course Outline

  • GMP Review and Interpretations for Validation and Qualification
    • Current GMP and FDA requirements
    • Process validation and performance qualification: US/EU
    • Interpretation and application of commissioning, design qualification, FAT and SAT
    • Conditions and limitations for retrospective and concurrent validations
    • Objective and preparation of master validation plans and related records
    • Worst-case, and bracketing and matrixing
    • Current compliance issues
  • FDA Process Validation Guidance Revision (Jan. 2011): Review of selected topics
  • Preparing the Validation/Qualification Protocols
  • Compliance Requirements for Installation Qualification
  • Compliance Requirements for Operation Qualification
  • Compliance Requirements for Process Validation
  • Compliance Requirements for Computer Validation
  • Compliance Requirements for Cleaning Validation
  • Preparing the Validation/Qualification Report