Meena Chettiar
Regulatory and Quality Manager at Promed Pharma
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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Recorded Webinar
Preparing for FDA Audits and Responding to FDA 483s in Pharmaceutical and Medical Device Industries
During this information-packed webinar, quality and regulatory professionals in the FDA regulated pharmaceutical and medical device industries will learn the key steps for being inspection ready for FDA audits, which can make or break your company based on how your Quality Management System (QMS) can withstand the scrutiny by the FDA auditors. The presenter who has participated in several FDA audits in both Pharmaceutical and Medical Device industries at the senior management level and as a facilitator of the FDA audits has a tremendous insight into the FDA Audit process.
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Understanding and Overcoming Challenges Encountered in Implementing the New ISO 13485:2016 Standard for Medical Device Quality Systems
You will gain a thorough insight into the specific quality system requirements of the all new International ISO 13485:2016 Quality System Standard requirements for Medical Devices. This extremely informative webinar will truly build your knowledge of the new ISO standard from the point of performing a risk based gap assessment followed by understanding the key challenges posed by this new "universally accepted" medical device standard. It will help you to fulfill the new quality and regulatory requirements as a professional working for medical device manufacturers of fully assembled devices and global suppliers manufacturing critical parts for the medical device industry. Key challenges posed to the medical device industry by this international standard will be discussed to pave the path for implementation of the changes in your organization.
Recorded Session Get life time access for one participant with download option!

The Blue Print for Implementing Pharmaceutical and Medical Device Quality Management System under one Umbrella
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.
Recorded Session Get life time access for one participant with download option!

Successfully Dealing with Out of Specification (OOS) Test results in the Pharmaceutical and Medical Devices Industry
Dealing with Out of Specification (OOS) test result the right way is a huge challenge to the pharmaceutical and medical device industry. FDA's Guidance Document to industry professionals for dealing with OOS test result is very detailed but often not fully understood and interpreted as intended even by experienced laboratory professions. Presenter of this webinar has over 20 years of experience in various industries (Food, Pharma and Medical Device) industries managing and responding to regulatory audits. The presenter has first-hand experience in handling several OOS test results successfully during her experience as senior QC Lab Manager and participating in successfully explaining her OOS approach at FDA, MHRA, ENVISA and PMDA audits. In this webinar, several practical scenarios will be visited so you can walk away with a clear approach to Successfully dealing with out of specification (OOS) Test results in the Pharmaceutical and Medical Devices industry right from confirmation of the OOS, investigation of the OOS in different phases and concluding the OOS satisfactorily so it can withstand scrutiny by regulatory bodies for years to come.
Recorded Session Get life time access for one participant with download option!

New ISO Standard for Medical Device Quality Systems 13485: 2016 Summary of its Impact to the Medical Device Industry Professionals
You will gain a thorough insight into the specific quality system requirements of all new International ISO 13485:2016 Quality System Standard requirements for Medical Devices. This timely and extremely informative webinar will truly build your knowledge from the fundamental quality principles. It will help you grow into fulfilling the quality and regulatory requirements as a professional working for medical device manufacturers of fully assembled devices and global suppliers manufacturing critical parts for the medical device industry. All noteworthy changes implemented into this key international standard will be discussed to pave the path for implementation of the changes in your organization.
Recorded Session Get life time access for one participant with download option!

Blue Print for Implementing Pharmaceutical and Medical Device Quality Management System under one Umbrella
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.
Recorded Session Get life time access for one participant with download option!

Understanding ISO 13485: 2015 Requirements for Medical Devices
The speaker will provide the background behind ISO 13485: 2015 and identify all areas that are being changed from the current ISO 13485: 2003 requirements for medical devices manufacturers. Steps involved in updating your current quality system to fulfill the updated quality requirements will be discussed. Timelines for compliance to the new standard and recommended steps will be clearly identified for the audience.
Recorded Session Get life time access for one participant with download option!

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