FDA Compliant QC and QA Practices: to Create a Perfect Audit –Ready QMS

Product Id : FDA201
Instructor : Joy McElroy
Jun 21, 2018 11:00 AM ET | 10:00 AM CT | 08:00 AM PT | 60 Minutes

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Overview

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?

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.

Learning Objectives

During this interactive, 90-minute webinar, you will:

  • 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 QMS
  • Recognize how to implement and apply GMP concepts to your Quality Control and Quality Assurance roles
  • Learn how to implement an effective audit ready QMS

Areas Covered in the Webinar:                                          

  • FDA Expectations of Quality Control and Quality Assurance
  • Common FDA findings with Quality Control and Quality Assurance departments
  • Requirements for a sound Quality Management System
  • Applying Good Manufacturing Practices (GMP) concepts to Quality Control and Quality Assurance
  • Implementing the QMS

Who will Benefit:

  • Quality Control professionals
  • Quality Assurance professionals
  • Validation professionals
  • Management and Supervisory Personnel
  • Regulatory Personnel
Speaker Profile:

Joy McElroy has 25 years’ experience in the pharmaceutical industry. She took her first steps into the industry in 1992, when she performed environmental monitoring and sterility testing at Pharmacia & Upjohn. Soon after, she became the supervisor at Abbott Laboratories, where she was responsible for overseeing the quality control lab. In 1998, Ms. McElroy was hired by Wyeth Lederle to work in quality assurance – where she performed GMP compliance audits, reviewed batch records, and held annual GMP training for new employees. After a few years working there, she moved to Mallinckrodt, where she was in equipment qualification and cleaning validation.

In 2013, Ms. McElroy started her own company, Maynard Consulting Company, which provides top auditors, validation specialists and engineers  to pharmaceutical, biotech and medical device clients across the world.


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