Overview:
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.
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.
Speaker
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.
Who Should Attend
- Quality
- Manufacturing
- Regulatory Affairs
- QA/QC/RA
- R&D Supply Chain
- Purchasing
