Setting up Quality System for FDA Regulated Products: Tips and Tricks for your Regulatory Compliance

Building a quality system that holds up under FDA and ISO audits takes more than a template. This 60-minute webinar gives a step-by-step guide and checklist for setting up a quality system for FDA-regulated products, drawn from first-hand experience with medical device, pharma, dietary supplement and cosmetic companies.

You'll learn how FDA quality system requirements apply to your product, the basic documentation you need, and which requirements are unique to each industry and which are common to all FDA-regulated products. The session also covers internal training and supplier management records, preparing for audits, and key FDA and ISO references and where to find details for your products.

• Explain FDA quality system requirements for your product
• Identify basic quality system documentation needs
• Separate industry-specific requirements from those common to all FDA-regulated products
• Prepare your quality system for FDA and ISO audits
• Plan training and supplier management documentation
• Find key FDA and ISO references for your products

• FDA quality system requirements for your product
• Basic quality system documentation
• Requirements unique to each industry and those common to FDA-regulated products
• Understanding requirements and preparing for audits
• Internal training and supplier management documentation
• Key FDA and ISO references and where to find information for your products

Knowing which quality system items are mandatory and which are nice to have helps you build a strong system and keep good records as proof of compliance. It is especially useful when adding products such as a drug-coated device that must meet both device and drug requirements.

This session suits quality directors and managers, regulatory professionals, QA/QC and production staff, senior leaders, and people moving into cosmetic or supplement companies from food, device or pharma.

• Quality Directors and Managers
• Regulatory Professionals
• QA/QC and Production Supervisors and Employees
• Upper Management leaders who want to understand the need to prioritize Quality resources

Meena Chettiar completed her education in India, Canada, and the United States where she completed master’s degrees in applied chemistry, Chemical Engineering, and Regulatory Affairs for Medical devices respectively. Meena has worked for Health Canada and Agriculture Canada as a Scientist and Quality Control Chemist. After immigrating to the United States Meena worked for Land O’Lakes and key Pharmaceutical and Medical device Companies such as Cephalon, Baxter, and Covidien in Minnesota, USA. Meena recently transitioned from serving as a Quality Director for Welly Health to the Head of Quality at a Cosmetic Company in the DC area.

Meena currently also serves as an Adjunct Instructor for the Medical Technology Program at St. Cloud State University. Meena is a passionate Quality content creator and presenter of webinars in Compliance and Quality. She is the author of Indiana Quality Council’s Biomedical Auditor Primer and is currently working on a Book for the American Society of Quality (ASQ). Meena has acquired several certifications from ASQ such as Quality Auditor, Quality Manager and Organizational Excellence, Quality Improvement Associate and Biomedical/Medical Device Auditor. Meena Chettiar is a continuous learner.