ARTICLES BY JOY MCELROY
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![Checklist]( "How To Write An Effective Validation Master Plan")
How To Write An Effective Validation Master Plan2/6/2019A validation master plan outlines the principles involved in the qualification of a facility, defining the areas to be validated, and provides a written program for achieving and maintaining a qualified facility.
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![Detect-Data-Integrity]( "Advanced Auditing Strategies To Detect Data Integrity Risks")
Advanced Auditing Strategies To Detect Data Integrity Risks11/26/2018Data integrity is essential in the pharma, biologics, and medical device manufacturing industries. Not only is complete, accurate, and reliable data necessary to assure drug safety and quality, the growing reliance on increasingly sophisticated digital systems means that issues relating to data integrity are increasingly complex.
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![pharma-equipment-monitoring]( "Writing Compliant IQ/OQ/PQ Protocols — Meeting FDA Expectations")
Writing Compliant IQ/OQ/PQ Protocols — Meeting FDA Expectations7/16/2018Writing effective IQ/OQ/PQ protocols is a must for following the regulations required by the FDA for equipment, systems, and utilities to demonstrate suitability for the intended use.
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![Writing Bulletproof SOPs: Best Practices For Life Sciences Companies]( "Writing Bulletproof SOPs: Best Practices For Life Sciences Companies")
Writing Bulletproof SOPs: Best Practices For Life Sciences Companies6/13/2018Writing and enforcing standard operating procedures (SOPs) is a challenge. Poorly written SOPs are a common cause of deficiencies and observations cited in 483s and warning letters from the FDA.
Joy McElroy
Joy McElroy is the founder of McElroy Training and Consultancy, LLC, which provides consultants and on- and off-site training to pharmaceutical and biotech companies throughout the U.S. With 25 years of experience in the pharmaceutical and biotech industries, she has gained extensive knowledge of quality assurance, technical writing, process and cleaning validation, equipment qualification, GMP compliance auditing, and computer system validation and part 11 compliance. McElroy has written and executed equipment qualifications and validation protocols for companies such as Mallinckrodt, Wyeth Lederle, Merck, BioMerieux, Catalent, Biotest, Novartis, Imprimis, Cody Laboratories, and Xceilence. You can reach her at joy@mcelroytrainingnconsultancy.com.