CAPA Simplified - A One-Form, Easy-To-Complete, Method for Simplifying Your CAPA Process
Duration: 60 Minutes
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This CAPA evaluation, implementation and integration webinar will discuss FDA regulatory requirements, how to evaluate your CAPA system, how to integrate with QMS and the best practices approach to initiation, evaluation and implementation of CAPA system along with discussion about CAPA documentation requirements.
07/12/2018 10:00 AMTraining Topic: CAPA Simplified - A One-Form, Easy-To-Complete, Method for Simplifying Your CAPA ProcessInstructor: Denise Wrestler
Objectives of the Presentation
Get an in-depth understanding of regulatory agencies such as the FDA 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 commonly-used root cause analysis functions
Understand some misconceptions with CAPA implementation
Tips and tricks for implementing a successful CAPA system
Why Should you Attend
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 fulfill 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.
Regulatory requirements for CAPA
Responsibilities of manufacturers
Best practices for CAPA implementation
Who will Benefit
Quality Control Personnel & Management
Manufacturing Personnel & Management
Regulatory Affairs Personnel & Management
Quality Assurance Personnel & Management
Supplier Quality Personnel & Management
Design Engineering Managers
Medical Device Engineering
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