Achieving Compliance with Robust CAPA Systems
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Industry :
Duration :
Course Description:
In order to solve problems every organization must know how to conduct an effective investigation, identify root causes, and implement workable corrective action in a timely manner. An effective CAPA process requires training internal investigators, who can also coach others in the organization, to employ critical thinking. The process must provide a common model and language within the organization, which allows investigators to master the process quickly and easily.
Why should you Attend?
This webinar will include discussions proper CAPA system maintenance, root cause analysis, documentation of the Corrective and Preventative Actions and developing a robust CAPA plan. It will give tips on how to develop CAPAs pertaining to longer term projects and ensure they stay on track.
Areas Covered:
- Definition of a CAPA
- When a CAPA is needed?
- Development of the essential pieces of a robust CAPA plan
- Root Cause Analysis Methods
- Discussion of different Root Cause Analysis methods and benefits of each
- Establishment of the CAPA Plan
- Project Summary development
- Responsibilities of individuals involved
- Establishing Completion Dates
- Creating meaningful effectiveness checks
- Management of the CAPA System
- Maintaining proper documentation of the CAPA plans
- Ensuring CAPA plans are progressing
- Proper close out of CAPA plans
- Discuss what to do when problems occur
- Outline the requirements of the CAPA process and procedure including building a CAPA file
- Choose the most appropriate Root Cause Analysis methods for the situation
Who will benefit?
- Quality Control Personnel & Management
- Manufacturing Personnel & Management
- Senior Management
- Regulatory Affairs Personnel & Management
- Quality Assurance Personnel & Management
- Supplier Quality Personnel & Management
Registration Options
Speaker Details
Danielle Delucy
Pharmaceutical Expert
Danielle DeLucy, prior to this role has been in the industry for 13 years serving in numerous Quality Management Roles, such as the Director of Product Quality, the oversight of Sterility Assurance practices and provided QA oversight of numerous filling and packaging operations. Danielle began her QA career as a Quality Control Pharmaceutical Microbiologist at Lancaster Laboratories, a contract laboratory where she performed various tests for their clients. In the years
Refund Policy
Participants/Registrants for our live events, may cancel up to 72 hours prior to the start of the live session and ComplianceTrain will issue a letter of credit to be used towards any of ComplianceTrain's future events. The letter of credit will be valid for 12 months.
ComplianceTrain will process refund in cases where the event has been cancelled and is not rescheduled within 90 days from the original scheduled date of the webinar. In case if a live webinar is cancelled, participants/registrants may choose between recorded version of the course or a refund. Refunds will not be processed to participants who do not show up for the webinar. A webinar may be cancelled due to unavoidable circumstances, participants will be notified 24 hours before the scheduled start of the event. Contact us via email: admin@ComplianceTrain.com
