๐ŸŽค  Meena Chettiar        |  ๐Ÿ“…  October 16, 2023   |  ๐Ÿ•’  11 AM Eastern Time US

Areas Covered in the Session :

  • FDA expectations based on Expertโ€™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


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.

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

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