Agenda Posted for Drug Master File (DMF) and Drug Substance Workshop

SBIA Conference

FDA | CDER | Small Business and Industry Assistance CONFERENCE Drug Master File (DMF) and Drug Substance Workshop March 3-4, 2021  This workshop is FREE. Registration and Agenda TOPICS 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 Ensuring high quality and manufacturing integrity of Active Pharmaceutical Ingredients (APIs) requires understanding and incorporation of quality and risk management principals throughout the API lifecycle. Specifically, the Agency wishes to provide guidance on the DMF submission process and expectations for content through a series of presentations, and panel discussions. 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.  AUDIENCE Manufacturers of active pharmaceutical ingredients in support of an ANDA or NDA (AAM, APIC, PhRMA, EFPAI, JPMA, DIA) Regulatory Affairs Professional or Agents  Outside testing facilities that provide data to support the safety (AMES Studies, (Q)SAR predictions, nitrosamine testing to support risk assessment) or quality (release or stability testers) of the active pharmaceutical ingredient in a DMF Outside manufacturing facilities that provide intermediates to be used in the manufacture of active pharmaceutical ingredients. Foreign Regulatory Bodies  Compendia   CONTINUING EDUCATION 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. The Small Business and Industry Assistance program in the Center for Drug Evaluation and Research (CDER SBIA) provides guidance, education and regular updates for regulated industry. Register for Upcoming Training Subscribe to CDER SBIA Email Updates Watch the Learning Library on YouTube Follow SBIA on LinkedIn Follow on Twitter This is an automated message delivery system. Replying to this message will not reach the CDER SBIA staff. If you have comments or questions, please contact us at CDERSBIA@fda.hhs.gov or 1-866-405-5367 or (301) 796-6707.   SUBSCRIBER SERVICES: Manage Subscriptions  |  Unsubscribe All  |  Help

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