Check out our Agenda for the CDER SBIA REdI Pharmaceutical Quality Symposium - July 20/21!

Come learn directly from CDER’s Office of Pharmaceutical Quality (OPQ)!

*  Conference Information  *

*  Register Here  *

* Agenda*

- Registration is required for both in-person and online attendance. -

 - Pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion -

 Agenda items include:

•  Introduction to the Office of Process and Facilities (OPF)
• Current Thinking on Microbiological Controls for Nonsterile Drug Products
• Aseptic Processing of Biological Products: Current Regulatory Issues
• Recommendations for Manufacturing Process Information in Prescription Drug Applications
• Manufacturing Process: Common Deficiencies and Recommendations for Information Request Responses
• Manufacturing Process Considerations for Immediate & Modified Release Products
• Manufacturing Process Considerations for Lyophilized Products 
• Current Submissions Expectations for Facility Information
• Lifecycle Facility Assessment
• Facility Assessment Considerations Panel
• Points to Consider for the CMC Review of Therapeutic Biologics
• Analytical Procedures and Method Validation
• Hot Topics – Drug Substance Review in CDER
• Emerging Technology
• Complex Drug Substances
• Risk Based Review
• Application of process capability in pharmaceutical manufacturing
• Post-Approval Change Management with sANDA Examples and Case Studies
• Biopharmaceutics Review – Current Practices and Expectations
• Proper CMC Submission-ANDA and Content of CMC Section

Don’t miss your chance to learn directly from the experts!

The Small Business and Industry Assistance program in the Center for Drug Evaluation and Research (CDER SBIA) provides guidance and information to regulated domestic and international small pharmaceutical business and industry through its website, email notifications, and workshops. This notification system provides current information from CDER/FDA via e-mail on a biweekly basis that is relevant to small pharmaceutical business, which includes Federal Register notices, guidances, workshop announcements, etc. This is an automated message delivery system. Replying to this message will not reach the CDER SBIA staff. If you have comments or questions, please contact us Monday through Friday 8:00AM - 4:30PM.

Email: CDERSBIA@fda.hhs.gov
Phone: 1-866-405-5367
Phone: (301) 796-6707
Website: http://www.fda.gov/cdersbia