Regulatory Inspections - How to prepare for a visit from an FDA Auditor
Instructor:
Joy McElroy
Product ID: 705725
Training Level: Basic
- Duration: 60 Min
Why Should You Attend:
This presentation will cover how to best prepare for these inspections to ensure the process is as quick and seamless as possible. We will cover what they are required to ask for, what they will likely ask for, and how to ensure you provide information requested in a timely manner. We will also go over some tips and tricks that will also help in ensuring a smooth audit as well as how to respond to the FDA once the audit is complete. At the end of the presentation, I will answer any questions or concerns you may have regarding the FDA auditing process.
Areas Covered in the Webinar:
- The purpose and scope of FDA audits
- FDA forms 482 and 483
- What exactly a QSIT audit entails and how to pass it
- How to Develop an audit preparedness plan that you can use to execute the audit
- Understand what the FDA will look for at the conclusion of your audit
- Do's and Don'ts on how to address FDA representatives
- Do's and Don'ts for your audit team
- Tips and tricks to ensure smooth audit experience
Who Will Benefit:
- Regulatory Professionals
- Quality Assurance Professional
- Executive Management
- Individuals involved with FDA compliance
Joy McElroy
Principle Consultant, Maynard Consulting Company
Upon earning a degree in Zoology at North Carolina State University, Joy McElroy 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, Ms. McElroy 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, she moved into equipment qualification and cleaning validation at Mallinckrodt.
With over 20 years total experience in the pharmaceutical and biotech industries, Ms. McElroy has gained extensive knowledge of quality assurance, process and cleaning validation, equipment qualification, sterilization, and GMP compliance auditing. Her knowledge, experience, and strong work ethic have made her a highly sought-after engineer in both the pharmaceutical and biotech industries.
In 2013, Ms. McElroy 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.
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