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

If your email program has trouble displaying this email, view as a webpage. August 5, 2021 Dear International Colleagues, The Office of Global Policy and Strategy would like to share this training presented by the FDA's Center for Drug Evaluation and Research. 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 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.

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