Minnesota Section 1203 Virtual Program Meeting: “Tips for Setting up FDA Audit Ready Quality Management System (QMS)”
Please join us for a virtual program meeting!
Date and Time
6:30 pm - 8:00 pm
About the Presentation
This presentation 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 Presentation 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.
Meena Chettiar has worked as a Quality Professional for over 3 decades and is excited to share her knowledge on setting up FDA audit ready Quality Management Systems at this MNASQ’s Program meeting in January 2022. Meena is a lifelong learner and teacher. She has managed manufacturing, testing new product development and quality management systems in the medical device, pharmaceutical, food industries and Health Canada. Meena’s passion is QA/QC/RA Management through interpretation of policies and global regulatory expectations, CAPA Remediation ensuring compliance at all levels of the company. Setting up systems to fulfil required commercial and post market product compliance, regulatory and clinical requirements for medical and pharmaceutical products is her current focus at Welly Health. Meena currently serves as the Director of Quality and Supplier Logistics for welly Health, Manufacturer of First aid Kits containing Class I medical devices and Over the Counter Pharmaceuticals. Meena teaches Part time at St. Cloud State University for their medical technology program. Meena Chettiar presents webinars on quality topics for the FDA World and has been teaching CAPA and DVV (Design Verification and Validation) and Testing for graduate students at St. Cloud State students of Medical Technology Quality as an Adjunct instructor for about 10 years.
Event Agenda and Details
Tuesday, 1/11/2022, from 6:30 pm to 8:00 pm
6:30 pm -- Welcome & Announcements
6:35 pm -- Section Business
6:45 pm -- Presentation
7:45 pm -- Closing Announcements
8:00 pm -- Meeting Adjourns
The Zoom link for the meeting will be provided in the confirmation email sent when your registration on ePLY is completed.
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