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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 and effective protocols.
Why attendees should register:
Attendees should attend to learn the requirements from regulatory agencies for IQ, OQ, and PQ protocols. They will learn the components of each protocol. Proper language for documenting qualification testing will be discussed. Collecting data, conducting tests, and obtaining all necessary documents will be discussed during this webinar as well.
Description of the topic:
Requirements from regulatory agencies for IQ, OQ, and PQ protocols will be discussed. Examples of deficient protocols will be given and discussed. Components of each protocol will be discussed in depth. Proper language for documenting qualification testing will be discussed. Collecting data, conducting tests, and obtaining all necessary documents will be discussed during this webinar as well.
Areas Covered in the Webinar Session:
· 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
Who will benefit:
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.