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.
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.
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.
Meena Chettiar
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 …
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