Process Validation Guidance Requirements, FDA, EU Annex 15, Qualification and Validation – 4 Hours Virtual Seminar

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

FDB2486

Joy McElroy

Upon earning a degree in Zoology at North Carolina State University, Joy began working in the pharmaceutical and biotech industries in 1992 at Pharmacia & UpJohn performing Environmental Monitoring and Sterility Testing. Her work allowed her to move into a supervisory role at Abbott Laboratories where she oversaw the Quality Control Lab. In 1998 Joy moved to Wyeth Lederle and worked in Quality Assurance, performing GMP Compliance audits, batch record reviews, and holding annual GMP training for new employees. After working in Quality Assurance for a few years, Joy moved into Equipment Qualification and Cleaning Validation at Mallinckrodt.

With 19 years of experience as a consultant, and over 25 years total experience in the pharmaceutical and biotech industries, Joy has gained extensive knowledge of Quality Assurance, Technical Writing, Process and Cleaning Validation, and Equipment Qualification and Computer System Validation and Part 11 Compliance. She has written and executed Equipment Qualifications and Validation Protocols for numerous Companies such as Mallinckrodt, Wyeth Lederle, Merck, BioMerieux, Catalent, and Biotest, Novartis, Imprimis, Cody Laboratories, and Xceilence.

Her knowledge, experience, have made her a highly sought-after engineer, technical writer, and trainer in both the pharmaceutical and biotech industries. Joy specializes in Equipment Qualification, Cleaning Validation, and GMP Compliance Auditing, and technical writing, and GMP, Audit Preparation, and SOP writing training, Computer System Validation and Part Compliance.

In 2019 she opened her own company, McElroy Training and Consultancy, LLC which provides consultants for various projects as well as on and off – site training to pharmaceutical and biotech companies throughout the United States.

Joy also spends her time mentoring and speaking as an Empowerment Speaker. Her goal is to empower people all over the world to live their dreams though implementing 5 simple techniques she has learned and applied through the years.

membership
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  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance