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://www.researchandmarkets.com/research/qsgb52/2day_seminar?w=4
