Process Validation Guidance Requirements, FDA, EU Annex 15; Qualification and Validation

Why Should You Attend:

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 Webinar:

• 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 Will Benefit:

• Internal Auditors
• Regulatory Compliance Personnel
• Validation Managers
• QA/QC Supervisors and Managers
• Facilities and Engineering Department Staff
• Manufacturing Supervisors and Managers
• Contract Manufacturers

Instructor Profile:

Upon earning a degree in Zoology at North Carolina State University, Joy McElroy made her debut in the pharmaceutical industry in 1992 at Pharmacia & UpJohn performing environmental monitoring and sterility testing. She then moved into a supervisory role at Abbott Laboratories where she oversaw their quality control lab. From there she moved into auditing clinical and GMP laboratories, and manufacturing facilities, then into validation engineering.

Now with 14 years’ experience as a consultant, and over 20 years total experience in the pharmaceutical and biotech industries, Ms. McElroy has gained extensive knowledge of quality assurance, process and cleaning validation, equipment qualification, auditing, and GMP and GLP training. She has written and executed equipment qualification and validation protocols for numerous companies such as Mallinckrodt, Wyeth Lederle, Merck, BioMerieux, Catalent, Phillips Medisize, Xcelience, and Novartis.

Ms. McElroy specializes in equipment qualification, cleaning validation, sterilization, environmental monitoring, GMP compliance auditing, Good Documentation Practices, and GMP and GLP training.

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