FDA Workshop for the Reproductive Tissue Industry - Sept 29 and Oct 1, 2020 September 29, 2020 - October 1, 2020

Public | Other

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• Date: September 29, 2020 - October 1, 2020
• Day1: Tue, Sep 29
• Day2: Thu, Oct 1

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Join FDA personnel for this two-day workshop:

Have you ever had questions regarding FDA regulations for reproductive tissues? Not sure who to contact or how to keep up with changes?

This workshop will introduce you to the FDA structure and resources available to you. It will also 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.

About the Workshop

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
• FDA Registration
• Required Labeling for Reproductive Tissues
• Exemption Request
• How to Handle Common Scenarios

Who Should Attend?

Those who are involved in handling human reproductive tissues, screening donors of human reproductive tissue, and/or ensuring that fertility clinics comply with FDA regulations:

• Physicians
• Nurses
• Consultants
• Other health professionals involved in the screening and recovery of reproductive donor tissues

To maximize the value of this course, we recommend attendees possess a basic understanding of the 21 CFR 1271 regulations.

Learning Objectives

• Explain how to handle several common situations that occur with reproductive tissue donors.
• Describe what procedures and records are required.
• Describe the various resources available to reproductive tissue facilities.
• Review screening and testing requirements for donors of reproductive tissue.

Speakers

Speakers include subject matter experts from ORA and CBER.

Resources

• 21CFR1271
• Resources for Industry
• Presentations
  • Welcome and Overview of the FDA Organization
  • What to Expect During an FDA Inspection
  • FDA Resources Presentation
  • FDA Resources Handout
  • Written Procedures and Required Records
  • Donor Screening
  • Donor Testing
  • Donor Eligibility and Summary of Records
  • Labeling for Reproductive Tissues
  • FDA Compliance
  • FDA Registration
  • CBER Exemption Request
  • How to Handle Common Scenarios

Recordings

• Recording for Day 1 (9/29/2020)
• Recording for Day 2 (10/1/2020)

Questions

• orabioinspectionalcorrespondence@fda.hhs.gov (Subject Line: Reproductive Workshop)

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Event Materials

Title	File Type/Size
Welcome and Overview of the FDA Organization	pdf (799.28 KB)
What to Expect During an FDA Inspection	pdf (242.39 KB)
FDA Resources Presentation	pdf (2.41 MB)
FDA Resources Handout	pdf (61.62 KB)
Written Procedures and Required Records	pdf (262.20 KB)
Donor Screening	pdf (2.39 MB)
Donor Testing	pdf (1.54 MB)
Donor Eligibility and Summary of Records	pdf (319.24 KB)
Labeling for Reproductive Tissues	pdf (236.72 KB)
FDA Compliance	pdf (355.15 KB)
FDA Registration	pdf (1.25 MB)
CBER Exemption Request	pdf (845.05 KB)
How to Handle Common Scenarios	pdf (507.46 KB)