FDA Compliant QC and QA Practices: Creating a Perfect, Audit-Ready QMS

01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 90 Minutes

Webinar Includes : All the training handouts , certificate ,Q/A and 180 mins Live Webinar

"Ms. Joy L. McElroy 12 years of experience as a consultant, and over 20 years total experience in the pharmaceutical and biotech industries"

General public assumes manufactured pharmaceutical products are safe

Description

In the pharmaceutical world, the term "quality" has several definitions. Generally speaking, quality means the product is fit for its’ intended use, is free from defects, and meets or exceeds customer expectations. The general public assumes manufactured pharmaceutical products are safe, efficacious, and have the correct identity. The Quality Control and Quality Assurance units within our manufacturing facilities are responsible for ensuring pharmaceutical companies manufacture quality products. Within those functions, some common questions arise…

  • What are the expected roles of Quality Control and Quality Assurance?
  • How are these roles related?
  • How are these roles different?
  • What is the expectation from the FDA and global health authorities for these two entities?
  • Finally, how is the perfect Quality Management System (QMS) created?

Why Should you Attend

The QMS is really the "glue" that holds it all together. Not only is your QMS a procedural set of systems and protocols meant to keep your product manufacturing on the straight and narrow, it is a show to regulators that you take product safety and patients seriously. Moreover, it is a global regulatory requirement. This webinar will answer these questions and provide pertinent information on how to create an audit-ready QMS.

Areas Covered

  • Discover FDA expectations for Quality Control and Quality Assurance
  • Review the roles of Quality Control and Quality Assurance in your facility
  • Learn how to avoid receiving 483s for Quality Control and Quality Assurance issues
  • Identify the requirements for a sound Quality Management System
  • Recognize how to implement and apply Good Manufacturing Practices (GMP) concepts to your Quality Control and Quality Assurance roles
  • Learn how to implement an effective audit ready QMS
  • Common FDA findings with Quality Control and Quality Assurance departments

Who will Benefit

This course will be of benefit to anyone working in a GMP regulated environment on global or domestic scale that works in a quality or related function. This includes personnel in:

  • Quality Control professionals
  • Quality Assurance professionals
  • Validation professionals
  • Management and Supervisory Personnel
  • Regulatory Personnel

Industries who can attend

This 90-minute online course is intended for professionals in the Medical Device, Biotechnology,Pharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel


Speaker Profile

Joy McElroy

Joy McElroy Upon earning a degree in Zoology at North Carolina State University, She made her debut in the pharmaceutical industry in 1992 at Pharmacia & UpJohn performing Environmental Monitoring and Sterility Testing. Her hard work allowed her to move into a supervisory role at Abbott Laboratories where she oversaw their 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 over 20 years total experience in the pharmaceutical and biotech industries, Joy has gained extensive knowledge of Quality Assurance, Process and Cleaning Validation, and Equipment Qualification. She has written and executed Equipment Qualification and Validation Protocols for numerous Companies such as Mallinckrodt, Wyeth Lederle, Merck, BioMerieux, Catalent, and Phillips Medisize. 

Her knowledge, experience, and strong work ethic have made her a highly sought-after engineer in both the pharmaceutical and biotech industries. Joy specializes in Equipment Qualification, Sterilization, Cleaning Validation, and GMP Compliance Auditing. 

Upon earning a degree in Zoology at North Carolina State University, She made her debut in the pharmaceutical industry in 1992 at Pharmacia & UpJohn performing Environmental Monitoring and Sterility Testing. Her hard work allowed her to move into a supervisory role at Abbott Laboratories where she oversaw their 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 Ma

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