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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!

About BioFlorida

BioFlorida represents nearly 6,000 establishments and research organizations in the biopharmaceutical, medical technology and bioagriculture sectors that collectively employ nearly 83,000 Floridians.


Members of the BioFlorida network include emerging and established life science companies, universities, research institutions, hospitals, medical centers, incubators, economic development agencies, investors and service providers.


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