DESCRIPTION:
The quality of a Pharmaceutical product has several definitions. Quality means the product is fit for its’ intended use, the product is free from defects, and the product 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. The questions become; 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 for these two entities? Finally, how is the perfect QMS created? This webinar will discuss these questions and provide pertinent information on how to create an audit ready QMS.(Read More)
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 GMP concepts to Quality Control and Quality Assurance
· Implementing the QMS
Key Learning Objectives of your Topic:
· The FDA expectations for Quality Control and Quality Assurance
· The role of Quality Control in your facility
· The role of Quality Assurance in your facility
· How to avoid receiving 483s for Quality Control and Quality Assurance issues
· The requirements for a Sound QMS
· How to implement and apply GMP concepts to your Quality Control and Quality Assurance roles
· How to implement an effective audit ready QMS.
Who will be benefited?
· Quality Control professionals
· Quality Assurance professionals
· Validation professionals
· Management and Supervisory Personnel
· Regulatory Personnel
Speaker: Joy L. McElroy :
Upon earning a degree in Zoology at North Carolina State University, Joy 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 10 years of experience as a consultant, and 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. In 2013 Joy 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. (For More Information)
