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

In this 60-minute webinar on “Setting up a Quality System for FDA Regulated Products: Tips and Tricks for your Regulatory Compliance” the presenter will provide a step-by-step guide and Checklist for the attendees. The presenter who has personally participated in setting up from scratch or improving existing Quality Systems (QS) for Medical Devices, Pharma, Dietary supplements, and Cosmetic Companies will share her firsthand experience with regulatory expectations. Items that are unique to each industry will be highlighted so that the attendees can build up QS that will withstand scrutiny by FDA and ISO Auditors. 

• Understanding FDA Requirements for your product in terms of quality system (QS)
• Basic QS documentation needs
• QS Requirements that are unique to each industry and those that are common to FDA-regulated products
• Audit readiness
• Training needs 
• References to key FDA and ISO requirements and where to get the details needed for your products 

• Understanding FDA Requirements for your product in terms of quality system (QS)
• Basic QS documentation needs
• QS Requirements that are unique to each industry and those that are common to FDA-regulated products
• Understanding the requirements and preparing for Audits
• Internal training and supplier management documentation needs for FDA-regulated products
• Details and key references to FDA and ISO requirements and where to get the basic information needed for your products

This webinar is extremely useful as Information on mandatory and nice-to-have items for your QS will be discussed so you can use the practical tips provided here for creating a bulletproof quality system for your company or as part of your ongoing continuous improvement of your QS and maintain excellent documentation as proof of your Quality Management System for regulatory compliance.  

This webinar will be extremely useful for Committed Quality professionals and their management in understanding quality expectations as one adds on new products such as a drug-coated device which will need to follow most of the Medical Device and Drug Compliance needs. 

In addition, folks who transition into a Cosmetic or Dietary supplement manufacturing company from a food or medical device/ pharma company will be able to successfully navigate into setting up a bulletproof Quality System.

• 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.