Process Validation Guidance Requirements, FDA, EU Annex 15, Qualification and Validation – 4 Hours Virtual Seminar
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This training program will illustrate how these two different concepts are integrated (Phase 1, 2, and 3 vs. Stages 1, 2, and 3) and where do they merge. Attendees will learn if they exist independently of each other or do they complement each other to enhance, build and provide a product.
This webinar will provide a channel to enhance understanding of the utilization of process validation and Phase 1, 2 and 3, where their guidances blend and where they remain distinct. In particular, Stage 3 continued process verification, will be reviewed in detail: where does it begin; what is included; and, when does it end.
Areas Covered in the Session :
- How these two different concepts are integrated (Phase 1, 2, and 3 vs. Stages 1, 2, and 3)
- Where do they merge?
- Do they exist independently of each other?
- Do they complement each other to enhance, build and provide a product?
- Where are the cGMPs initiated?
- To what extent must cGMPs be used?
- What happens after Stage 3 extends through commercial batch manufacturing?
- What happens to Phase 3?
- How does Phase 3 follow along or with Stage 3?
Who Should Attend:
- Internal Auditors
- Regulatory Compliance Personnel
- Validation Managers
- QA/QC Supervisors and Managers
- Facilities and Engineering Department Staff
- Manufacturing Supervisors and Managers
- Contract Manufacturers
Course Director: JOY MCELROY
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