FDA Compliant QC and QA Practices: to Create a Perfect Audit –Ready QMS
Instructor : Joy McElroy
Jun 21, 2018 11:00 AM ET | 10:00 AM CT | 08:00 AM PT | 60 Minutes
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.
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