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

Duration: 75 Minutes
flat 50% off on this webinar
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…
FDA Compliant QC and QA Practices
Instructor: Joy McElroy
Product ID: 503858
  • 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?
Objectives of the Presentation
During this interactive, 75-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 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
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.

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
$300
Recorded Session for one participant
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How it works
Live Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • The webinar joining link, username and password for joining the webinar will be updated on your OCP Account 24 hours prior to the webinar
  • Presentation handouts in Downloadable PDF format will be updated on your OCP Account 24 hours prior to the live session
  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Upon earning a degree in Zoology from North Carolina State University, Joy McElroy 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, Ms. McElroy 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, she moved into equipment qualification and cleaning validation at Mallinckrodt.

With over 20 years of total experience in the pharmaceutical and biotech industries, Ms. McElroy has gained extensive knowledge of quality assurance, process and cleaning validation, equipment qualification, sterilization, and GMP compliance auditing. Her knowledge, experience, and strong work ethic have made her a highly sought-after engineer in both the pharmaceutical and biotech industries.

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


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