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2-day, Regulatory Education for Industry (REdI) : Pharmaceutical Quality Symposium | Maryland
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2-day, Regulatory Education for Industry (REdI) : Pharmaceutical Quality Symposium | Maryland

CDER SBIA is pleased to announce its upcoming 2-day, Regulatory Education for Industry (REdI) : Pharmaceutical Quality Symposium You can attend in-person or virtually. Registration for this event is FREE This conference is a must for anyone involved in pharmaceutical manufacturing.

7/20/2016 to 7/21/2016
When: 07/20-21/2016
Where: DoubleTree by Hilton Hotel Washington DC - Silver Spring
8727 Colesville Road
Silver Spring, Maryland  20910
United States

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SBIA REdI Pharmaceutical Quality Symposium 2016

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!


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