The Blue Print for Implementing Pharmaceutical and Medical Device Quality Management System under one Umbrella

Duration: 75 Minutes
As the global distributers and manufacturers of Medical devices and pharmaceuticals expand their quality management system (QMS) to cover the pharmaceutical and medical device requirements under one umbrella, the need to understand the quality system requirements that are unique to each industry becomes very crucial. In this webinar, the presenter with 1st hand proficiency in setting up and speaking the quality language of medical device and the pharma world will provide unique tips for those companies that are making the transition from medical device to pharmaceuticals and vice versa or in to the fast growing world of drug coated medical devices also known as Combination Products.
Quality Management System
Instructor: Meena Chettiar
Product ID: 501995
Objectives of the Presentation
  • What are the features of QMS that are common to the pharma and medical device QMS?
  • Which features are unique to the world of medical devices for globally marketed products?
  • Which features are unique to the pharmaceutical/drug world?
  • What is required to fulfill the cGMP needs of the fast growing Combination products?
  • How should the gap analysis be performed for a seamless transition?
  • Planning and implementation of your QMS under one umbrella to successfully withstand scrutiny by worldwide regulatory bodies and for your overall business risk management
Why Should you Attend
Professionals are often thrown into the challenge of adapting and expanding their quality system requirements in order to accommodate their expanding business and customer needs. This webinar will help you overcome the challenge by educating you on the QMS needs that are common and those that are unique to Pharma and Medical device world so you can focus on areas that need to be nurtured as you make this important transition from 21 CFR 210/211 to 21 CFR 820 and vice versa to fulfill FDA regulatory needs for your effective quality system that will be housed under one umbrella.

Areas Covered
  • QMS requirements for pharma world for products distributed globally
  • QMS requirements for medical devices distributed globally including ISO 13485 requirements
  • QMS requirements for combination devices
  • Categorization and prioritization of your unique QMS needs for successful integration
  • What are the consequences of not housing your QMS under one umbrella?
  • What are the practical benefits of effectively managing your Quality system under one umbrella?
  • How can implementation of this knowledge provide you a competitive advantage over similar players in your business?
Who will Benefit
  • Quality Managers/ Directors
  • QA/QC and Regulatory Professionals in pharmaceutical and medical device industries
  • Quality Engineers and Quality Auditors
  • Supply Chain Managers/Auditors
  • Management professionals in FDA Regulated industries
  • R&D and design engineers
  • Global professionals looking for employment in medical device and pharmaceutical industries
Topic Background
Key knowledge for FDA regulated Industries expanding their quality management system to accommodate growth or amalgamating quality systems to increase efficiency for medical products.
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Live Session - How it works
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  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
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  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Ms. Chettiar has a very strong background in Quality in the FDA regulated industries. Ms. Chettiar received her M.S. in Regulatory Affairs for Medical Devices in Minnesota, USA, and M.A. SC in Chemical engineering from University of British Columbia in Canada and her B.S. and M.S in Applied Chemistry from the University of Madras, India. Ms. Chettiar is also very knowledgeable in Clinical Research auditing for medical devices and pharmaceutical products.

Meena is currently working as a Senior Associate at NAMSA and is the Founder and Principle Consultant of MNQ Consulting Services LLC. Meena has worked as Quality and Regulatory Manager at ProMed Pharma, Medical and combination device manufacturer, a Senior Supplier Quality Engineer for Covidien with drug coated balloons and guide wires, for Baxter Bio Surgery, as a Senior Quality Manager at Teva Pharmaceuticals for over 10 years and as QC lab supervisor at Land O' Lakes. Meena has also worked for Agriculture and Health Canada in several technical capacities for about 10 years. Meena has performed mock QSIT Audits and has responded to several FDA 483s.

Meena has played a key role in quality system implementations in the food, pharmaceutical, and medical device industries. Meena has participated as the lead supplier/internal/GMP auditor in several compliance audits in the US, Canada, Puerto Rico and Costa Rica. Meena is the Chair elect for MNASQ (American Society for Quality) this year. Meena is ASQ certified CQA (Certified Quality Auditor), CBA (Certified Biomedical Auditor), CQIA (Certified Quality Improvement Associate), and CMQ/OE (Certified Manager of Quality/Organizational Excellence).

Meena has served as an instructor for these ASQ certification classes since 2006. She is a certified instructor for ASQ learning institute for CBA and an adjunct instructor for Medical Technology Quality graduate program for St. Cloud State University in Minnesota. Meena is a coauthor of the CBA (Certified Biomedical Auditor) Primer for the Quality Council of Indiana and is very passionate about Installation and growth of Quality Systems in general.
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