Online Webinar 2019 - Live Webinar FDA Compliant QC and QA Practices: Creating a Perfect, Audit-Ready QMS

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?
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.
Session Highlights
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
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