Excipients: Compliance with Compendial and GMP Requirements

By: Todd Graham ,Managing Partner, Delevan Street Biosciences.

Excipients must be evaluated with each drug they are included with to ensure that they can be used safely

  • 21-January-2020| 01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 60 Minutes

Good Manufacturing Practices Training | GMP Course

By: Todd Graham ,Managing Partner, Delevan Street Biosciences.

We will review how all of this work should be documented

  • 18-March-2020| 01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 60 Minutes

Verification and/or Validation to meet US FDA CGMP and ISO 13485 Requirements

By: John E Lincoln ,Principal of J. E. Lincoln and Associates LLC.

Both the U.S. FDA and EU's MDD/MDR expect documented risk-based "master" and "individual" V&V planning

  • 19-May-2020| 01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 60 Minutes
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