SBIA | Tomorrow - Manufacturing, Supply Chain, and Inspections during the COVID19 Public Health Emergency Webinar

U.S. Food and Drug Administration sent this bulletin at 08/24/2021 07:00 AM EDT

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FDA | CDER | Small Business and Industry Assistance

WEBINARS

Manufacturing, Supply Chain, and Inspections during the COVID19 Public Health Emergency

August 25, 2021 | 9:00 a.m. - 1:00 p.m. Eastern

Register

Webinar participants will hear the latest updates from FDA’s Center for Drug Evaluation Research (CDER) regarding policy and approaches toward manufacturing, supply chain, and inspections during the COVID19 Public Health Emergency (PHE).

TOPICS

FDA guidance on manufacturing during COVID-19 and high absenteeism
Risk management and application approaches in responding to supply chain constraints during public health emergency
Inspections and use of alternate tools during the public health emergency

AUDIENCE

Quality unit leaders
Quality and manufacturing personnel
Regulatory affairs professionals who manufacture drugs for the US market (inclusive of application and non-application products)

CONTINUING EDUCATION

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.

This course:

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.