Auditing Quality Suppliers
Friday, March 2, 2018 12:30 PM - 1:30 PM EST
The various regulatory agencies have expectations that life sciences manufacturers 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.
Join us for this LTEN webinar, designed for people tasked with performing internal and external audits for their organizations. It is also for those tasked with developing, maintaining and/or improving programs for manufacturing facilities. This includes individuals that have Quality Management Systems responsibilities for making general improvements in their organization’s performance specifically related to equipment, processes and documentation.
Joy McElroy, founder of Maynard Consulting, will speak with you about issues including preparing for regulatory compliance auditing, proper auditor conduct, skills needed for conducting regulatory compliance audits and writing an audit report. At this webinar, you will learn:
- What a regulatory compliance audit is.
- The background and basics of regulatory compliance auditing.
- What skills are necessary for conducting audits.
- How to prepare and plan for a regulatory compliance audit.
- Proper questioning techniques.
- How to conduct a follow-up audit.
Upon earning a degree in Zoology at North Carolina State University, Joy 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 Joy 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, Joy moved into Equipment Qualification and Cleaning Validation at Mallinckrodt.
With 10 years of experience as a consultant, and over 20 years total experience in the pharmaceutical and biotech industries, Joy has gained extensive knowledge of Quality Assurance, Process and Cleaning Validation, and Equipment Qualification. She has written and executed Equipment Qualification and Validation Protocols for numerous Companies such as Mallinckrodt, Wyeth Lederle, Merck, BioMerieux, Catalent, and Phillips Medisize.
Her knowledge, experience, and strong work ethic have made her a highly sought-after engineer in both the pharmaceutical and biotech industries. Joy specializes in Equipment Qualification, Sterilization, Cleaning Validation, and GMP Compliance Auditing.
In 2013 Joy 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.
Register today for this free, LTEN webinar. Not an LTEN member? Join today and realize the value.