CAPA Simplified – A one-form, Easy-to-Complete, Method for Simplifying Your CAPA Process
Duration : 60 Minutes
Denise Wrestler, ASQ CQE, CQA,
With over 15 years of experience
All medical device manufacturers are required to have a robust Corrective and Preventive Action (CAPA) system in place. Does your company have one? Is it easy to use? Does it work? Are you certain you know what CAPA is?
This presentation will cover the FDA regulations (21 CFR Subpart J) regarding CAPA, how CAPA should be integrated into other branches of your Quality Management System, how to best approach CAPA (including initiation, evaluation, and follow-up verification), examples of documentation you can use to fulfil the CAPA requirement, as well as tips and tricks to what FDA auditors will look for when they come to visit your site. We will also go over some additional tips and tricks on how to convey the importance of CAPA within your organization and ensure resources are provided to meet CAPA process needs. At the end of the presentation, I will answer any questions or concerns you may have regarding the CAPA process.
Course Objectives:
• Get an in-depth understanding of what regulatory agencies such as the FDA are requiring for CAPA.
• Evaluate your already-existing CAPA process to determine if it meets requirements.
• Determine if your CAPA system is robust enough to ensure actions are effective or overly-complicated and preventing smooth operation.
• Overview of
• Understand some misconceptions
• Tips and tricks for implementing a successful CAPA system.
Course Outline:
• Regulatory requirements for CAPA
• Responsibilities of manufacturers
• Best practices for CAPA implementation
• FDA expectations
• Documentation requirements
What You Get:
• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points
Who Will Benefit:
• Quality Control Personnel & Management
• Manufacturing Personnel & Management
• Senior Management
• Regulatory Affairs Personnel & Management
• Quality Assurance Personnel & Management
• Supplier Quality Personnel & Management
• Development Engineers
• Production Management
• QA/QC Personnel
• Software Developers
• Usability engineers
• Risk managers
• Design Engineering Managers
• Medical Device Engineering
• Quality Assurance
• Regulatory
• Management
Please reach us at 1-888-844-8963 for any further assistance or if you wish to register
100% MONEY BACK GUARANTEED
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