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.
Why You Should 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 audit 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.
Areas Covered in the Session :
- General information on FDA audits including sample 483s
- Bullet proof your quality system through careful preparation for the FDA visit
- Learn want to expect during the FDA audits
- How can you prepare for FDA audits right from your product design stage
- 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
- 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
- How mock QSIT audits performed by experienced auditors can escalate your preparedness
- 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
Who Should Attend:
- Regulatory Affairs Departments
- Quality Assurance Departments
- Quality Control Departments
- Compliance Departments
- Research and Development Departments
- Engineering Departments
- Manufacturing Departments
- Product Development Departments
- Design Engineers
Course Director: MEENA CHETTIAR
Meena Chettiar currently works as a Quality and regulatory Manager at ProMed Pharma in Minneapolis. Meena has worked as a Senior Supplier quality engineer at Covidien, Senior Quality Associate (Lead Auditor and CAPA Coordinator) at Baxter Bio Surgery in St. Paul, MN. Meena worked as a Senior Quality Control Manager at Teva Pharmaceuticals for over 10 years and as Instrumentation lab supervisor at Land O’ Lakes. Meena has also worked for Agriculture and Health Canada in several technical capacities for about 10 years before immigrating to the United States.
Meena made the transition to the medical device industry after completing a MS in Regulatory Affairs for Medical Devices through St. Cloud State University in 2010. Meena has played a key role in quality system implementations in the food, pharma, and medical device industries. Meena has participated as the lead supplier/internal/GMP auditor in several Compliance audits in the US and abroad. She has a strong auditing background in the pharmaceutical and medical device auditing. 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 been serving as an instructor for these ASQ certification classes since 2006 and has conducted quality and medical device related training classes in her current position at Baxter.
Meena is a coauthor of the CBA (Certified Biomedical Auditor) primer for the Quality Council of Indiana. She is currently an adjunct instructor for the medical technology quality program at St. Cloud State University in Minnesota. Ms. Chettiar received her M.S Regulatory Affairs and Services for Medical Devices from St. Cloud State, Minnesota, M.S. in Chemical engineering from University of British Columbia and her B.S. and M.S in Applied Chemistry from the University of Madras, India. Meena is happy to teach webinars for the Compliance Trainings and continue to contribute towards quality and regulatory compliance.