Step-by-Step approach for Setting up FDA Audit Ready Quality Management System (QMS) – Case Studies based training

This webinar will discuss the key features involved in setting up / building your Quality Management System (QMS) so you are ready for FDA and other supplier/ISO certification related audits. Manufacturers of FDA regulated products such as medical devices, nutraceuticals, food and pharmaceutical products need to understand and abide by several requirements and establish them as part of their QMS to support their cGMP processes. Expectations by FDA for Quality Management Systems (QMS) are becoming increasingly stringent. Product manufacturers are finding it very challenging to sustain their QMS for FDA registered products in the market, particularly when our supply chain is becoming increasingly global.

This webinar will dive into the key QMS requirements that are common between 21 CFR 210/211 (Pharmaceutical), 820 (Med devices) and 111 (Dietary supplements) and refer to some of the unique expectations for each of the FDA regulated industries. Tips will be provided on the key aspects that companies should focus on while setting up their QMS so they can maintain their QMS and come out of their audits with minimal/no observations. Quality associates, Design/ Manufacturing Engineers, QA/QC/ RA professionals associated with the FDA regulated medical device, pharmaceutical and nutraceutical industries are the target audience for this presentation. All professionals committed to cGMP manufacturing in our highly regulated quality environment will find the practical examples to be extremely valuable tools for the rest of their professional lives. If you are a quality or a regulatory professional in a small start-up company or an established global manufacturer, you are bound to walk away with a few valuable tips to set up/address gaps in your QMS and become FDA audit ready.

Areas Covered in the Session :

• FDA expectations based on Expert’s personal experience in setting up Quality Systems (QS) in Pharma and device companies
• Examples based on the FDA Requirements for setting up quality systems so you can integrate them into your company SOPs
• Pathways for successfully interpreting regulatory expectations for QMS
• Practically dealing with quality system setup needs
• FDA expectations for quality systems from 1st hand experience with QS
• Laying a strong foundation for successfully setting up your FDA complaint quality system
• Step-by-step approach for setting up your quality system
• Preventing mistakes and avoiding FDA 483s during audits
• Getting ISO Certification
• The presentation will contain several practical examples and case studies

Who Should Attend:

• Quality Assurance Departments
• Quality Control Departments
• Research and Development Departments
• Regulatory Affairs Departments
• Manufacturing Departments
• Engineering Departments
• Quality Engineers
• Inspection Engineers
• Quality Auditors

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.