ARTICLES BY JOY MCELROY
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![iStock-522474830]( "An Introduction To Quality Agreements For Pharmaceutical Outsourcing")
An Introduction To Quality Agreements For Pharmaceutical Outsourcing4/17/2020Any time a contractor or CMO is used, including arrangements between different divisions of the same company, regardless of the location of the parties involved, there should be a quality agreement in place.
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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.
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.