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FDA Announces Reproductive Tissue Workshop

On September 29th and October 1st, the FDA will be hosting a virtual workshop for the Reproductive Tissue Industry.

Each day will run from 11:00 AM - 4:30 PM ET, and is designed to introduce attendees - to include physicians, nurses, and other professionals involved in the screening and recovery of reproductive donor tissues – to the FDA structure and resources available to you. The workshop also will provide detailed information on current requirements for donor screening and testing, labeling, registration, and donor eligibility determination. Several common scenarios involving oocyte and semen donors will be discussed so that you will know how to handle them.

Topics include:
  • Overview of FDA organization
  • What to Expect During an FDA Inspection
  • Guidance Documents, Helpful Websites, FDA Email List
  • Written Procedures and Required Records
  • Donor Screening and Donor Testing
  • Donor Eligibility and Summary of Records (SOR)
  • FDA Compliance…and more. 
Speakers include subject-matter experts from ORA and CBER.

For more information, visit this page.

To register, click here.

Questions? Contact orabioinspectionalcorrespondence@fda.hhs.gov (Please use the Subject Line: Reproductive Workshop)

 

ReproductiveFacts.org
is a patient education website of ASRM.
 

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