- April 9, 2021
1:00 PM - 4:00 PM ET
This webinar is FREE.
This follow-on webinar will focus on answering attendee questions regarding the posters and presentations given at the Drug Master File (DMF) and Drug Substance Workshop on March 3-4, 2021. Questions received from industry before March 19, 2021, at DMFWorkshop2021@fda.hhs.gov may be answered as well as questions submitted during the workshop. There will be an opportunity for live questions and panel discussion with subject matter experts.
There are also 19 poster presentations on a variety of topics. All are invited to view the poster presentations and submit questions for any of them to DMFWorkshop2021@fda.hhs.gov.
- 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
- All participants of SBIA-DMF/Drug Substance Workshop of March 3 and 4, 2021.
- 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
Real-time attendance is required for the certificate of attendance which can be used in support of CEs for the following professional organizations. Certificates are only available during the two weeks post-event.
- has been pre-approved by RAPS as eligible for credits (appropriate to real-time attendance) 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 1 non-GCP or non-GLP unit 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.
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