2-Day Seminar: Process Validation Guidance Requirements - FDA and EU Annex 15 (Boston, MA, United States - May 10-11, 2018)
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.
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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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Laura Wood, Senior Manager
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SOURCE Research and Markets