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Preparing for FDA Audits and responding to FDA 483s in Pharmaceutical and Medical Device industries
- General information on FDA audits including sample 483s
- How can you prepare for FDA audits right from your product design stage
- Documentation requirements for all elements of your QMS
- What can one do during the audits to show off your quality and compliance to FDA inspector
- Mock FDA audits and QSIT audits for pharma and device industries respectively
- How can you recover from FDA 483s and use them to learn and grow your product compliance and extend the lessons learned to your entire product line
Overview of the webinar
During this information-packed webinar, quality and regulatory professionals in the FDA regulated pharmaceutical and medical device industries will learn the key steps for being inspection ready for FDA audits, which can make or break your company based on how your Quality Management System (QMS) can withstand the scrutiny by the FDA auditors. The presenter who has participated in several FDA audits in both Pharmaceutical and Medical Device industries at the senior management level and as a facilitator of the FDA audits has a tremendous insight into the FDA Audit process.
You will learn first to:
- Bullet proof your quality system through careful preparation for the FDA visit
- Learn want to expect during the FDA audits
- Learn how to respond to major non-conformances presented as 483s by the FDA auditors
- How to respond to the FDA 483s, learn and grow from them
- How mock QSIT audits performed by experienced auditors can escalate your preparedness
- In summary learn what to expect from FDA audits, how to respond to FDA 483s and warning letters with confidence and nurture your quality system on an ongoing basis.
Who should attend?
- VP of Quality
- Director of QA/QC
- Manufacturing Directors and Managers
- Regulatory and Compliance professionals
- Quality and Manufacturing Engineers
- R&D and product development professionals
Why should you attend?
FDA regulated Pharma and Medical Device industry's top management, Quality Directors, QA/QC Managers, Senior Quality and Manufacturing Engineers and QA and Regulatory Personnel should attend this session to learn about what FDA Inspectors look for when they audit your company.
Preparation and planning that is indispensable to make this audits painless and what is expected of you when you are handed out a non-conformance as a 483 is the key reason for you to attend this unique session packed with practical information. The presenter will share her experiences from the several FDA audits that she has been fortunate to be part of in the FDA regulated industries in the United States and her experience in preparing companies for FDA pre approval and follow up inspections before and after 483s. The earlier you learn the FDA rules and expectations, the better off you will be in setting up and maintaining a bullet proof quality system.
Faculty - Ms.Meena Chettiar
Meena Chettiar, the founder and lead consultant of MNQ Consulting Services LLC, currently works as a senior Associate for NAMSA in Minneapolis, MN, USA. Meena has over 25 years of experience working in Quality and Compliance for Health Canada, big medium, and small scale FDA regulated Food, Pharma and Medical device industries in the United States such as Teva Pharmaceuticals, Baxter, and Covidien. Ms. Chettiar received her M.S. in Regulatory Affairs for Medical Devices and Post graduate certification in Applied Clinical Research from St.Cloud State University, Minnesota, USA, Chemical engineering from the University of British Columbia in Canada and her B.S. and M.S in Applied Chemistry from the University of Madras, India. Meena is an Exemplar Global Certified Principal Auditor with over 20 years of auditing experience in pharmaceutical and medical device industries in the US and countries like India, Canada, Costa Rica and Puerto Rico.
Meena has worked for Health Canada and Agriculture Canada for about 10 years in various technical capacities. Meena has participated as the lead supplier/internal/GMP and clinical auditor in several compliance audits in the US and abroad for Pharmaceutical API, Excipients and medical device suppliers including testing and sterilization service suppliers. Meena has represented her companies in several FDA and several global regulatory audits. Meena is a senior member of ASQ (American Society for Quality) and is ASQ certified CQA (Certified Quality Auditor), CBA (Certified Biomedical Auditor), CQIA (Certified Quality Improvement Associate), and CMQ/OE (Certified Manager of Quality/Organizational Excellence).She has served as an instructor for these ASQ certification classes since 2006 and as an adjunct instructor for Medical Technology Quality Master’s Program at St. Cloud State University since 2013 Meena enjoys presenting webinars on “current” topics related to quality and compliance for FDA regulated industries. Meena Chettiar is also the coauthor of QCI’s CBA Primer and was nominated as the distinguished Scientist by Minnesota Federation of Scientists, Engineers, and Technologists in 2016.