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.
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.
Areas Covered in the Session :
Get an in-depth understanding of what regulatory agencies such as the FDA are requiring for CAPA.
Responsibilities of manufacturers
Evaluate your already-existing CAPA process to determine if it meets requirements.
Documentation 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.
Who Should Attend:
Quality Assurance Departments
Quality Control Departments
Regulatory Affairs Departments
Engineering Departments
Validation Departments