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
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
CAPA board roles and responsibilities
Preventing FDA 483s, warning letters and recalls
Who Will Benefit:
Process Engineering Departments
Research & Development Departments
Design Assurance Departments
Quality Assurance Departments
Quality Control Departments
Production Operators and Supervisors
Document Control Departments