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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![Complaints-iStock-889460444]( "An Introduction To Adverse Event Reporting And Product Complaints For Pharma Companies")
An Introduction To Adverse Event Reporting And Product Complaints For Pharma Companies4/23/2019Managing complaints and controlling adverse events are critical tasks for a pharmaceutical company. While varying international regulations for adverse event reporting and product complaint handling make it difficult to automate processes and implement SOPs, it is necessary for companies to successfully resolve incidents and continue on a path to innovation.
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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.
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![How To Make Sure Your Foreign Vendors Are FDA Compliant — And Stay That Way]( "How To Make Sure Your Foreign Vendors Are FDA Compliant — And Stay That Way")
How To Make Sure Your Foreign Vendors Are FDA Compliant — And Stay That Way5/4/2018Choosing a foreign vendor is no different than choosing a domestic vendor; foreign vendors are held to the same FDA standards as domestic vendors. Manufacturers must have assurance that their foreign vendor will not be the source of major issues.
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![Audit Checklist]( "How To Build An FDA Audit-Ready QMS — A Primer")
How To Build An FDA Audit-Ready QMS — A Primer3/21/2018This article will address the roles of quality control and quality assurance, how these roles are related and how they are different and how they must work together to create a sound quality management system.
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![Sartorius]( "An Introduction To Analytical Instrument Qualification & Validation — Meeting FDA Expectations")
An Introduction To Analytical Instrument Qualification & Validation — Meeting FDA Expectations2/16/2018Analytical instruments can provide a high level of confidence in the integrity and quality of the manufactured product through scientific data, and that confidence can only be achieved through proper instrument qualification
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.