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.
April 7, 2020
10:00 AM PST | 01:00 PM EST
More Trainings by this Expert
Product Id : 502883
Live: One Dial-in One Attendee
Corporate Live: Any number of participants
Recorded: Access recorded version, only for one participant unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)
Corporate Recorded: Access recorded version, Any number of participants unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)
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:
Who Will Benefit:
- Change Control requirements and sources
- FDA comments on the failure to use proper change management
- How to set up your Change Management Systems
- Regulatory Affairs
- R&D Supply Chain
Courtland Imel is CEO of Ceutical Laboratories. Courtland has provided training to FDA, Health Canada, and state regulatory authorities. Courtland has spoken at AFDO, AFDOSS, MCAFDO, ASQ, SCC, and Bio. Courtland has 35 years of experience in the industry. Courtland is an SME for several organizations and law firms. Courtland worked for M&M Mars, Allergan, ILEX Oncology, Aronex Pharmaceuticals, Mills Biopharmaceuticals, International Isotopes, Avail Medical Products, Carrington Laboratories, and Ceutical Laboratories, Inc. Courtland has assisted in the submissions of 510Ks, PMAs, IND’s, NDAs, ANDAs, IDEs, and more.
Ceutical Labs provides many services including product development, formulation development, analytical testing (chemistry, microbiology, and physical), regulatory submissions, electronic submissions, consulting, training, quality systems, and more.