2-Day Seminar: Process Validation Guidance Requirements - FDA and EU Annex 15 (Boston, MA, United States - May 10-11, 2018) - ResearchAndMarkets.com

This two day, interactive seminar which provides a conduit to enhance your understanding of the Continued Process Verification, will be reviewed in detail: where does it begin; what is included; and, when does it end.

These questions will be addressed within Stage 2 as presented here and include utilization of Process Validation and Phase 1, 2 and 3, where their Guidances blend and where they remain distinct. In particular, Stage 3.


Day 01 (8:30 AM - 5:00 PM)

  • 08.30 AM - 09.00 AM: Registration
  • 09.00 AM: Session Start
  • Introduction, Goals and Objectives, Definitions. Process Validation - Its Importance within the Drug Industry
  • Interaction of the Three Stages with Process Validation
  • Validation Approaches, cGMPs in Clinical Supply Manufacture, Special Manufacturing Situations within Phase 1
  • The Requirements of Phase 1 Investigational Drug Requirements
  • Regulatory Strategies for Phase 2 and 3 and their Incorporation within Stages 1 and 2

Day 02 (8:30 AM - 4:30 PM)

  • General Considerations for Process Validation - Stage 2 Process Qualifications
  • Special Considerations for Process Validation - Stage 2
  • General Considerations for Process Validation - Stage 3 Continued Process Verification
  • A Review of EU Annex 15 and its Comparison to FDA's Process Validation Guidance
  • Concurrent Release of Process Performance Qualification (PPQ) Batches
  • Analytical Methodology and Process Validation; Warning Letter examples

For more information about this conference visit https://www.researchandmarkets.com/research/qsgb52/2day_seminar?w=4

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