This equipment qualification webinar will discuss the requirements for IQ, OQ, and PQ protocols. It will train about the various components of each protocol, Proper language for documenting qualification testing including how to Collect data, conduct tests, and obtaining all necessary documents.
Why Should You Attend:
Regulatory Agencies expect Pharma, Biologics, and Medical Device manufacturers to maintain control over their equipment. The FDA and various other regulatory agencies are finding deficiencies with the qualification of analytical and manufacturing equipment. A large number of the deficiencies occur due to poorly written IQ, OQ, and PQ protocols. Proper equipment qualification cannot occur without an effective protocols.
Attend this webinar to learn about requirements from regulatory agencies for IQ, OQ, and PQ protocols, examples of deficient protocols. Components of each protocol will be discussed in depth. Proper language for documenting qualification testing will be discussed including methods of Collecting data, conducting tests, and obtaining all necessary documents.
Areas Covered in the Webinar:
- Regulatory Requirements for writing IQ, OQ, PQs
- Components of an effective IQ, OQ, and PQ
- Proper language used to author protocols and documenting test results
- Collecting Data
- Conducting Tests
- Protocol Templates
- Writing generic IQ, OQ, and PQ protocols
- Obtaining necessary documentation
Instructor Profile:
Joy McElroy
Principle Consultant, Maynard Consulting Company
Principle Consultant, Maynard Consulting Company
Upon earning a degree in Zoology at 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.