Preparing for a FDA Inspection
Joy McElroy entered the pharmaceutical industry in 1992 shortly after earning a Bachelor of Science degree at North Carolina State University. She began at Pharmacia and UpJohn performing environmental monitoring and sterility testing. From there she moved into a supervisory role at Abbott Laboratories where she oversaw the 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. She has worked all around the United States performing GMP compliance audits, writing and executing cleaning validations, and equipment qualifications, and performing technical writing.
With over 30 years of total experience in the pharmaceutical and biologics industries, Ms. McElroy has gained extensive knowledge of quality assurance, process and cleaning validation, environmental monitoring, equipment qualification, sterilization, GMP compliance auditing, and technical writing. Joy currently works for Actalent Services, LLC as the Validation Manager for sciences where she works with a team of highly qualified technical individuals to provide managed services to pharmaceutical, medical device, and biologics companies around the world.
This webinar will discuss the types of FDA audits and why they occur, the Do's and Don'ts during an FDA inspection, how to properly answer questions from an inspector, the significance of 483s and warning letters, as well as lessons learned from previous FDA inspections.
- Facilities under the watchful eye of the FDA
- The 4 types of FDA inspections and why they occur
- FDA Expectations
- What to do before an inspection?
- What happens during an FDA inspection?
- What documents and records will the FDA ask to see?
- Proper conduct during an FDA inspection
- Responding to FDA questions and request
- How did the inspection end?
- Responding to the FDA inspection report, 483's, and warning letters
Cours Level - Intermediate
Who Should Attend
- Quality Assurance Personnel
- Validation Personnel
- Validation Management
- Manufacturing Personnel
- Quality Control Personnel
- Quality Management
- Engineering personnel
- Engineering Management
Why Should You Attend
You should attend this webinar to learn the purpose of an FDA inspection, the types of FDA inspections and why they occur, what happens during an inspection, how to prepare for an FDA inspection, proper inspection conduct, and proper response to questions from FDA inspectors.
From drugs to medical devices to nutraceuticals and imports, the FDA inspects all manufacturers that produce products to GxP standards for compliance.
Under the Federal Food, Drug, and Cosmetic Act, the FDA is required to inspect manufacturers at least once every two years even more for companies just getting started, those with a history of compliance problems, and those who have started producing products significantly different from what they produced before.