Overview:
The presentation will include recent comments by MCA and FDA on the use of criminal supply chains and how to spot them.
The presentation will review the current situation of recent recalls by small firms. The presentation will cover how to establish good supply chain procedures and what to seek in such a system.
The presentation will include FDAs recent guidance document on supply chain for Compounding Pharmacies and how others can use these same standards.
The presentation will include recent comments by MCA and FDA on the use of criminal supply chains and how to spot them.
The presentation will review the current situation of recent recalls by small firms. The presentation will cover how to establish good supply chain procedures and what to seek in such a system.
The presentation will include FDAs recent guidance document on supply chain for Compounding Pharmacies and how others can use these same standards.
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
