Division of Clinical Research

Office of the Vice President and Innovation

March 3-4, 2021. This workshop is FREE.

Register here: https://www.fda.gov/drugs/news-events-human-drugs/drug-master-file-dmf-and-drug-substance-workshop-03032021-03042021?utm_medium=email&utm_source=govdelivery

Ensuring high quality and manufacturing integrity of Active Pharmaceutical Ingredients (APIs) requires understanding and incorporation of quality and risk management principles throughout the API lifecycle.  This conference is designed to provide an update on current Agency initiatives and will cover a wide variety of topics of interest to API manufacturers and regulators.  Specifically, the Agency wishes to provide guidance on the DMF submission process and expectations for content through a series of presentations, panel discussions, and Q&A for two poster sessions.  The desired outcome is to outline the various regulatory steps necessary for the successful development of a high-quality submission of drug substance information to the Agency.  


  • Information on submitting and managing DMFs, fee payments, and facility identification
  • How to maximize communication tools offered by the agency to get answers to your questions
  • What to consider for development of a complex API
  • Process validation and ICH Q7
  • How to select an appropriate regulatory starting material (ICH Q11 and Q11 Q&A)
  • Expectations for impurity assessment ((Q)SAR & pharm-tox) and control (ICH Q3A, Q3C, Q3D, and M7)
  • How to develop a robust chromatographic method for API release
  • Expectations for Lifecycle Management of DMFs and the Draft Post-Approval Change Guidance 
  • Common mistakes and how to avoid them-:  case study examples
  • Posters covering topics of interest


Real-time attendance is required for the certificate of attendance. Certificates are only available during the three weeks post-event. This course:has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.has been pre-approved by SOCRA who accepts documentation of candidate participation in continuing education programs for re-certification if the program is applicable to clinical research regulations, operations or management, or to the candidate’s clinical research therapeutic area.has been pre-approved by SQA as eligible for 0.25 non-GCP or non-GLP units for every 1 hour of instructional time towards a participant’s RQAP re-registration.has been approved by ACRP for continuing education in clinical research. ACRP will provide 1 ACRP contact hour for every 45-60 minutes of qualified material.

Categories FDA Regulatory

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