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

DUBLIN, April 12, 2018 /PRNewswire/ --

The "Process Validation Guidance Requirements (FDA and EU Annex 15: Qualifications and Validation): 2-Day Workshop " conference has been added to ResearchAndMarkets.com's offering.

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.

Agenda

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/65fs2x/2day_seminar?w=5

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SOURCE Research and Markets