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

Receive this email as a forward? Subscribe to CDER SBIA industry updates. 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. The Small Business and Industry Assistance (SBIA) program in the Center for Drug Evaluation and Research provides guidance, education and updates for regulated industry. Register for Upcoming Training Watch Learning Library Recordings on YouTube Subscribe to CDER SBIA Email Updates Follow 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, contact us at CDERSBIA@fda.hhs.gov or 1-866-405-5367 or (301) 796-6707.   SUBSCRIBER SERVICES: Manage Subscriptions  |  Unsubscribe All  |  Help

This email was sent to ooseims.archieves@blogger.com using GovDelivery Communications Cloud on behalf of: U.S. Food and Drug Administration ·  10903 New Hampshire Ave · Silver Spring, MD ·  20993-0002 ·  1-888-INFO-FDA