Meena Chettiar
Meena Chettiar
Meena Chettiar currently works as a Quality and regulatory Manager at ProMed Pharma in Minneapolis. Meena has worked as a Senior Supplier quality engineer at Covidien, Senior Quality Associate (Lead Auditor and CAPA Coordinator) at Baxter Bio Surgery in St. Paul, MN. Meena worked as a Senior Quality Control Manager at Teva Pharmaceuticals for over 10 years and as Instrumentation lab supervisor at Land O’ Lakes. Meena has also worked for Agriculture and Health Canada in several technical capacities for about 10 years before immigrating to the United States.
Meena made the transition to the medical device industry after completing a MS in Regulatory Affairs for Medical Devices through St. Cloud State University in 2010. Meena has played a key role in quality system implementations in the food, pharma, and medical device industries. Meena has participated as the lead supplier/internal/GMP auditor in several Compliance audits in the US and abroad. She has a strong auditing background in the pharmaceutical and medical device auditing. Meena is a senior member of ASQ (American Society for Quality) and 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). She has been serving as an instructor for these ASQ certification classes since 2006 and has conducted quality and medical device related training classes in her current position at Baxter.
Meena is a coauthor of the CBA (Certified Biomedical Auditor) primer for the Quality Council of Indiana. She is currently an adjunct instructor for the medical technology quality program at St. Cloud State University in Minnesota. Ms. Chettiar received her M.S Regulatory Affairs and Services for Medical Devices from St. Cloud State, Minnesota, M.S. in Chemical engineering from University of British Columbia and her B.S. and M.S in Applied Chemistry from the University of Madras, India. Meena is happy to teach webinars for the Compliance Trainings and continue to contribute towards quality and regulatory compliance.
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How to use Quality Systems Inspection Technique (QSIT) to Your Advantage
Large and small medical device companies have a challenge in preparing for and dealing with FDA audits. Quality and Manufacturing personnel in charge of creating and maintaining your quality management system for all of the medical devices manufactured at... -
A to Z of Supplier Management in the Medical Device Industry
Supplier management is an integral part of any quality system in regulated industries. Quality System regulation (QSR) and ISO 13485 have specific supplier management requirements that you are answerable to. FDA is getting more rigid about supplier audits and... -
Step-by-Step approach for Setting up FDA Audit Ready Quality Management System (QMS) – Case Studies based training
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,... -
Handling OOS Test Results as per Latest FDA Guidance – 2022
Out of Specification (OOS) Test Results presents a major challenge to several in house and contract testing laboratories as FDA and other regulatory agencies’ expectations in this area are very rigid and specific. Successfully interpreting regulatory expectations in this... -
FDA Quality System Inspection Technique (QSIT) Audits – Good Preparation Practices
Large and small medical device companies have a challenge in preparing for and dealing with FDA audits. Quality and Manufacturing personnel in charge of creating and maintaining your quality management system for all of the medical devices manufactured at... -
Quality by Design (QbD) in Pharmaceutical and Medical Device Manufacturing
Incorporating a strong quality system during pharmaceutical drugs and medical device design and development by understanding the unique product design and development requirements for final approval and marketing of medical devices and pharmaceuticals through global regulating bodies such as... -
Quality System Regulations for Combination Products
This webinar will explain the quality system regulations (QSR) for combination device manufacturers to ensure compliance with for FDA and ISO 13485 requirements. It will also provide practical tips to sustain the growth of your quality system in the... -
ISO 13485:2016 Requirements and Compliance to Latest Updates
Key changes to the ISO 13485:2016 Effective Gap Assessment with ISO 13485 Updating your procedures to ensure compliance on an ongoing basis Observing every individual element that had been enhanced under ISO 13485: 2016 Successfully auditing to the new... -
MDSAP Audits – All You Need to Know
After the final FDA approval and initiation of marketing of your medical devices, regulating bodies such as US FDA and other regulatory bodies send their inspectors on a periodic basis to device manufacturing facilities. Now, the new MDSAP, Medical... -
Design Verification, Validation and Testing for Medical Devices
Design Control is an integral part of any quality system in regulated industries. FDA Quality System regulation, Quality System Inspection Techniques (QSR and QSIT) and ISO 13485: 2016 have specific product verification and validation requirements that must be fulfilled... -
Dealing with Out of Specification (OOS) Test Results
Dealing with OOS presents a major challenge to several laboratories. Successfully interpreting regulatory expectations in this area and practically dealing with OOS results from USP, non USP chemical, microbiological and physical test measurements will be described in this valuable... -
FDA Quality System Inspection Technique (QSIT) Audits – Good Preparation Practices
Large and small medical device companies have a challenge in preparing for and dealing with FDA audits. Quality and Manufacturing personnel in charge of creating and maintaining your quality management system for all of the medical devices manufactured at... -
Preparing yourself for Compliance to ISO 13485:2016
You must attend this unique webinar presented by an expert trainer to add all the necessary tools to your quality, risk management, auditing and regulatory tool kit and lay the foundation to make the switch to the brand new... -
Good Preparation Practices for FDA Audits and Responding to FDA 483s
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... -
Test Methods and Standards for Design Verification & Validation
Design Control is an integral part of any quality system in regulated industries. FDA Quality System regulation, Quality System Inspection Techniques (QSR and QSIT) and ISO 13485: 2016 have specific product verification and validation requirements that must be fulfilled... -
ISO 13485:2016 – Proposed Changes to the International Medical Device Standard
ISO 13485:2016 – Are you prepared to understand and implement the changes being finalized by the ISO technical committee for the long awaited update to the medical device standard ISO 13485:2003?. Awareness of the upcoming key requirements and proposed... -
How to Develop a strong CAPA System by Understanding its Unique Challenges
Large and small medical device and pharmaceutical companies have a challenge in dealing with their CAPA program, specifically in performing a timely, unbiased, scientifically sound root cause analysis and verification of effectiveness for the changes implemented. This webinar will... -
ISO 13485:2016 – Proposed Changes to the International Medical Device Standard
Description: ISO 13485:2016 – Are you prepared to understand and implement the changes being finalized by the ISO technical committee for the long awaited update to the medical device standard ISO 13485:2003?. Awareness of the upcoming key requirements and... -
Design Verification, Validation and Testing for Medical Devices
Description: Design Control is an integral part of any quality system in regulated industries. FDA Quality System regulation, Quality System Inspection Techniques (QSR and QSIT) and ISO 13485 have specific product verification and validation requirements that must be fulfilled... -
Extending Your Quality System from Medical Devices to Manufacturing of Combination Products, Your Unique Challenges and How to Overcome them
Description: This webinar is intended to demonstrate 510(k) contents and format including 510(k) processes in accordance with FDA’s eCopy and RTA policy so that your time, energy and financial resources can be effectively used to accelerate your 510(k) preparation,... -
FDA proposed changes to ISO 13485: 2015 and Medical Devices Quality Management Systems
Description: Differences in regulatory requirements between Medical Devices and Pharmaceutical products poses unique challenges to companies that want to manufacture devices that contain drugs and biological products (aka Combination Devices). Large and small medical device companies who want to... -
Key Areas of Focus for Supplier Management in the Medical Device Industry
Description: Design Control is an integral part of any quality system in regulated industries. FDA Quality System regulation, Quality System Inspection Techniques (QSR and QSIT) and ISO 13485 have specific product verification and validation requirements that must be fulfilled... -
Key Areas of Focus for Supplier Management in the Medical Device Industry
Design Control is an integral part of any quality system in regulated industries. FDA Quality System regulation, Quality System Inspection Techniques (QSR and QSIT) and ISO 13485 have specific product verification and validation requirements that must be fulfilled in... -
ISO 13485:2016 – Proposed Changes to the International Medical Device Standard
Description: ISO 13485:2016 – Are you prepared to understand and implement the changes being finalized by the ISO technical committee for the long awaited update to the medical device standard ISO 13485:2003?. Awareness of the upcoming key requirements and... -
Design Verification, Validation and Testing for Medical Devices
Description: Design Control is an integral part of any quality system in regulated industries. FDA Quality System regulation, Quality System Inspection Techniques (QSR and QSIT) and ISO 13485 have specific product verification and validation requirements that must be fulfilled... -
Extending Your Quality System from Medical Devices to Manufacturing of Combination Products, Your Unique Challenges and How to Overcome them
Description: This webinar is intended to demonstrate 510(k) contents and format including 510(k) processes in accordance with FDA’s eCopy and RTA policy so that your time, energy and financial resources can be effectively used to accelerate your 510(k) preparation,... -
FDA proposed changes to ISO 13485: 2015 and Medical Devices Quality Management Systems
Description: Differences in regulatory requirements between Medical Devices and Pharmaceutical products poses unique challenges to companies that want to manufacture devices that contain drugs and biological products (aka Combination Devices). Large and small medical device companies who want to... -
Navigating your way through ISO 13485
Description : ISO 13485 is the International Standard that specifies the regulatory requirements for medical device Quality Management System (QMS). The purpose of this webinar on ISO 13485 is for Quality management system implementers,Quality/regulatory managers and bio medical auditors’... -
Navigating your way through ISO 13485
Description : ISO 13485 is the International Standard that specifies the regulatory requirements for medical device Quality Management System (QMS). The purpose of this webinar on ISO 13485 is for Quality management system implementers,Quality/regulatory managers and bio medical auditors’...
