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:
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.
Netzealous LLC, DBA -Compliance4all
Email: [email protected]
Contact Info Netzealous LLC, DBA -Compliance4all Email: [email protected] Phone: +1-800-447-9407 Website: https://www.compliance4all.com/
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