Change Management System
This webinar will describe how FDA expects firms to establish change management, the sources of change management, the outcomes from change management, and timely outcomes. We will cover some suggestions and Do's and Dont's.
Tuesday, April 7, 2020
10:00 AM PST | 01:00 PM EST
60 Minutes
More Trainings by this Expert Product Id : 502883
The presentation will focus on FDA responses to failures in Change Management. The presentation shall describe how FDA expects firms to establish change management, the sources of change management, the outcomes from change management, and timely outcomes. We will cover some suggestions and Do's and Dont's.
Why you should Attend:
Why attend? One of the largest areas for FDA review is Change Control Management, as it incorporates Document Control, Validation, Manufacturing, Quality Control, R&D and other groups within an organization.
Many smaller firms struggle with proper documentation to ensure change control management. Larger firms use electronic systems, but again to fail to complete documentation in a timely manner and also review related documentation.
Areas Covered in the Session:
- Change Control requirements and sources
- FDA comments on the failure to use proper change management
- How to set up your Change Management Systems
Who Will Benefit:
- Quality
- Manufacturing
- Regulatory Affairs
- QA/QC/RA
- R&D Supply Chain
- Purchasing
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