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 pave a solid path to those who want to make their CAPA system the strongest link in their quality system. Understanding the major considerations in the regulatory requirements as part of the continuous improvement efforts to fulfilling the quality system requirements (QSR) is the key. The ever changing, fast growing, complex arena of medical devices and pharmaceutical GMP makes it necessary for the US FDA registered products and globally distributed medical products to withstand a solid CAPA scrutiny at all times.

This webinar presents important facts to simplify the planning and execution phase of your CAPA in addition to learning the tricks to ensure that the essential quality system requirements for your CAPA System is always audit proof. The experience shared at this webinar is based on proven successful practices. Practical CAPA 483 avoidance tips that will be useful to employees of established and emerging medical device and pharma manufacturers will be presented.

Areas Covered in the Session :
CAPA requirements per Quality System Regulations 21 CFR 820, 210/211 and ISO 13485
Current Guidance Documents
What works for CAPAs dealing with different manufacturing areas and different product histories
Importance of preventive action system to reduce number of CAPAs in the long run
Risk-Based Assessment
Essential component of a well-documented CAPA system
Root Cause of product/system failures, nonconformance, product complaints, and audit findings
Prevention of failure repeatation
Quality Tools to be used to close the CAPA
Testing for long term effectiveness of the changes
Practical examples
CAPA board roles and responsibilities
Preventing FDA 483s, warning letters and recalls

Who Will Benefit:
Manufacturing Departments
Process Engineering Departments
Research & Development Departments
Design Assurance Departments
Quality Assurance Departments
Quality Control Departments
Production Operators and Supervisors
Document Control Departments
Regulatory Departments

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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  • Presentation Handout in .pdf format
  • Certificate of Attendance