Equipment Qualification and Process Validation

Why Should You Attend:

Lack of qualification or validation is a common FDA inspectional observation and FDA Warning Letter violation. Those involved in equipment qualification, including information technology (IT) and process validation will benefit from a review of the relevant FDA rules, written and unwritten.

FDA current Good Manufacturing Practice (GMP) regulations require that all equipment be qualified and all manufacturing processes validated.

Equipment qualification includes Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ). All three will be discussed and examples from both manufacturing and laboratory equipment will be provided. Retrospective qualification of previously unqualified equipment already in place will be considered. Qualification of computer systems will also be presented.

Process validation involves proof that each step of a manufacturing process does what it is supposed to do. The degree of proof required will be discussed. When sampling after a step will not provide accurate information (e.g. some blend uniformity test results) will be considered.

These equipment qualifications and process validations must be repeated if changes are made or if problems are encountered, and periodically as necessary. How often to revalidate will be discussed.

Attend this webinar to understand each of the above process for equipment qualification & steps for process validation of FDA cGMP regulations.

Areas Covered in the Webinar:

• General FDA GMP information re qualification and validation
• Equipment Qualification
• IQ
• OQ
• PQ
• Computer System Qualification and Part 11
• Manufacturing Process Validation
• Specifications
• When to test
• What to test
• How much to test

Who Will Benefit:

• Personnel responsible for equipment qualification
• Personnel responsible for computer system qualification
• Personnel responsible for manufacturing process validation
• Regulatory Affairs, Regulatory Compliance
• Quality

Joy McElroy
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.

With over 20 years total experience in the pharmaceutical and biotech industries, Ms. McElroy has gained extensive knowledge of quality assurance, process and cleaning validation, equipment qualification, sterilization, and GMP compliance auditing. Her knowledge, experience, and strong work ethic have made her a highly sought-after engineer in both the pharmaceutical and biotech industries.

In 2013, Ms. McElroy 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.

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