Original broadcast date: Wednesday May 11, 2016
Presenter: Joy McElroy
Regulatory agencies expect that suppliers and vendors will demonstrate control over their manufacturing processes, validations, and documentation. Quality auditing is the process of checking whether these organizations have implemented what they have stated in written procedures and whether their people are doing what the organization's procedures state they will do.
During this webinar you will learn:
- The basics of auditing suppliers and vendors to enable you to choose the highest quality supplies and services for your laboratories
- Methods for qualifying and validating your analytical instruments to demonstrate application suitability
- The processes involved, from planning and writing requirement specifications to vendor assessment, installation, and operational qualification and ongoing testing during routine use
- How to prepare for FDA audits and how to become part 11 compliant
Joy McElroy offers 14 years of experience as a consultant, and over 20 years total experience in the pharmaceutical and biotech industries in quality control and clinical and GMP auditing as well as validation engineering. Joy specializes in equipment qualification, cleaning validation, sterilization, environmental monitoring, GMP compliance auditing, good documentation practices, and GMP and GLP training. She has written and executed equipment qualification and validation protocols for numerous companies such as Mallinckrodt, Wyeth Lederle, Merck, BioMerieux, Catalent, Phillips Medisize, Xcelience, and Novartis.