Process Validation Guidance Requirements (FDA and EU Annex 15: Qualifications and Validation)

The Process Validation Guidance Requirements (FDA and EU Annex 15: Qualifications and Validation) is a seminar that covers topics such as:

  • What FDA segments are included and excluded within the "NEW" Process Validation
  • Why these FDA Guidance for Industry/EU Guidelines - Process Validation is so important to the pharmaceutical and biotechnology industry
  • What are the Three Stages and Where Do They Apply within the NEW Process Validation
  • Where does the Process Validation commence
  • The Validation approaches that are included within this Guidance document
  • How Stage 1 integrates with Phase 1
  • An Introduction to Phase 1 Guidance for Industry and Its Application within the "NEW" Process Validation
  • The Statutory and Regulatory Requirements for Process Validation
  • General Considerations for Process Validation - Stage 2 Process Qualification
  • The Phase 1 Investigational Drug Requirements -- What is and What is NOT Required
  • General Considerations for Process Validation - Stage 3 Continued Process Verification
  • Regulatory Strategies for Phase 2 and 3 and their Incorporation within Stages 1/2
  • A Review of EU Annex 15 and its Comparison to FDA`s Process Validation Guidance

The Process Validation Guidance Requirements (FDA and EU Annex 15: Qualifications and Validation) brings together senior attendees from:

  • Microbiology Professionals
  • Facilities
  • Quality Control personnel
  • Quality Assurance personnel
  • Research & Development
  • Regulatory Affairs Professionals
  • Auditors
  • Validation

Important

Please, check the official conference website for possible changes, before you make any traveling arrangements

Prices are for evaluation only.

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