DUBLIN–(BUSINESS WIRE)–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://ift.tt/2qzz6SL
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