SBIA Webinar | FDA Inspections of Outsourcing Facilities

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Receive this email as a forward? Subscribe to CDER SBIA industry updates. FDA | CDER | Small Business and Industry Assistance WEBINARS FDA Inspections of Outsourcing Facilities Date: April 6, 2022 Time: 2:00 PM - 3:00 PM ET Registration ABOUT THIS WEBINAR  During this webinar, FDA will: Provide an overview of the inspection process for compounding outsourcing facilities. Discuss what to expect during an inspection, from initiation to closeout as well as observations on successes and challenges. INTENDED AUDIENCE  Compounding outsourcing facilities Compounding pharmacies with interest in the outsourcing facility sector and FDA compounding inspections State pharmacy regulators Consultants focused on outsourcing facilities and compounding pharmacies FDA-regulated industry or general public with an interest in the inspections process for compounding pharmacies and outsourcing facilities FDA RESOURCES Regulatory Policy Information | FDA Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice Human Drug Compounding Compounding Quality Center of Excellence | Training Programs FDA SPEAKERS Jessica Pressley McAlister Pharmacy Compounding National Expert Division of Pharmaceutical Quality Programs (DPQP) Office of Pharmaceutical Quality Operations (OPQO) Office of Regulatory Affairs (ORA) Food and Drug Administration (FDA) Lori Cantin, PharmD, MS, RPh Captain, U.S. Public Health Service Branch Chief Branch 3 Division of Compounding II Office of Compounding Quality & Compliance (OCQC) Office of Compliance (OC) Center for Drug Evaluation and Research (CDER) FDA 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 is: pre-approved by RAPS as eligible for a maximum of 12 credits for a two day event (appropriate to real-time attendance) towards a participant's RAC recertification upon full completion. 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. 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. 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

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