Implementing a Bullet Proof Quality System for FDA Audit Success
Instructor:
Meena Chettiar
Product ID: 705400
- Duration: 60 Min
Why Should You Attend:
This webinar will offer an overview of FDA expectations for medical device and combination product manufacturers for auditing their facility’s quality system. It will also cover key audit elements which will help attendees to set up their documentation in order to implement a bullet proof quality system to come out of FDA audits successfully.
Upon completion of this webinar, attendees will get an insight into all aspects of FDA audit requirements for medical devices so that they can prepare well and come out of the FDA audits without observations that can tarnish their product quality and marketing reputation.
Areas Covered in the Webinar:
- Getting to know your Quality System (QS) in its entirety to fulfil FDA requirements for your QS
- Familiarizing yourself with your products from R&D to cGMP production and documentation of the evolution of your commercialized product
- Getting all your paperwork prepared per GDP (Good Documentation Practices) as evidence in order to withstand FDA scrutiny at the FDA audit
- Understanding QSIT ( Quality System Inspection Techniques) requirements for:
- Document Controls, Personnel and Training
- Supplier and Purchasing Controls, Receiving and Shipping Inspections
- Production and Process Controls and Corrective and Preventive Actions
- Packaging and Labelling Controls, Test Equipment, Testing and Laboratory Controls, Out of Spec Testing Requirements
Who Will Benefit:
- R&D Professionals
- Quality and Manufacturing Personnel
- Regulatory Professionals
- QC/QA Personnel
- Senior Management
Meena Chettiar
Principal Quality Engineer, Freudenberg Medical
Meena Chettiar is currently working as a Principal Product Development Quality engineer at Freudenberg Medical in Minnesota, USA. Meena has worked in several capacities over the past 20 years in several high level Quality and Regulatory Management positions at pharmaceutical and medical device companies such as ProMed Pharma, Covidien, Teva Pharmaceuticals and NAMSA. She has also worked as QC lab supervisor at Land O’ Lakes in Minnesota and for Agriculture and Health Canada in several technical capacities for about 10 years.
Meena has participated as the lead supplier/internal/GMP auditor in several compliance audits in the US, India, Costa Rica, Mexico and Puerto Rico. She 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 served as an instructor for these ASQ certification classes since 2006. She is a certified instructor for ASQ learning institute for CBA and has been an adjunct instructor for Medical Technology Quality graduate program for St. Cloud State University in Minnesota since 2013. She is a coauthor of the CBA (Certified Biomedical Auditor) Primer for the Quality Council of Indiana.
Ms. Chettiar received her M.S. in Regulatory Affairs for Medical Devices in Minnesota, 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.
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