Investigating and Reporting Adverse Reactions Related to Human Cells, Tissues, and Cellular and Tissue Based Products (HCT/Ps)

Duration: 60 Minutes
This webinar will review and provide a practical approach to investigating and reporting complaints of adverse reactions related to HCT/Ps. The FDA has implemented a risk-based approach to the regulation under 21 CFR Part 1271 for HCT/Ps to prevent the introduction, transmission and spread of communicable disease.
HCT/Ps
Instructor: Kristen McCoy
Product ID: 501482
The new guidance provides recommendations for complying with the requirements for investigation and reporting of complaints of adverse reactions involving communicable disease in recipients of 361 HCT/Ps. It is important that all establishments performing a manufacturing step related to an HCT/P understand their responsibility in the process and the importance of investigating, sharing information and reporting adverse reactions.

Objectives of the Presentation
  • Background and scope of the guidance for industry released March 2016 - Investigating and Reporting Adverse Reactions
  • Review of regulatory recommendations regarding investigating and reporting adverse reactions
  • A practical guide to investigating complaints of adverse reactions concerning HCT/Ps
  • What to expect when an establishment is investigating an adverse reaction
  • Notifying and sharing information with other establishments that are known to have recovered HCT/Ps from the same donor
  • When and how to submit reports of adverse reactions
  • Review of completing form FDA 3500A (MedWatch)
Why Should you Attend
Any establishment that provides human tissue intended for implantation, transplantation, infusion or transfer into a human recipient must have a system in place to properly investigate and report complaints of adverse reaction to the FDA. This webinar will provide guidance in understanding the FDA's current recommendations, provide a practical approach to developing and implementing a structured process for investigating and reporting adverse reactions, and provide process improvement initiatives to ensure that your establishment is in compliance.

Who can Benefit
  • Individuals working at the regulatory affairs of any HCT/P establishment
  • Quality professionals working in HCT/P establishments
  • Medical Director or physicians who oversee HCT/P establishments
  • Physicians and consumers using HCT/Ps
Topic Background
The FDA has issued a guidance that provides additional recommendations specific to an establishment's responsibilities for complying with the requirements under 21 CFR Part 1271, Subparts Dand E, for investigating and reporting of complaints of adverse reactions involving communicable disease in recipients of 361 HCT/Ps. This guidance supersedes the FDA guidance entitled "Guidance for Industry: MedWatch Form FDA 3500A: Mandatory Reporting of Adverse Reactions Related to Human Cells, Tissues and Cellular and Tissue Based Products (HCT/Ps). This guidance also finalizes the draft guidance of the same title dated February 2015.
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  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
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  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Kristen McCoy is the Vice President of Clinical Operations for Eversight, a network of community of eye banks around the world. She currently leads the regulatory affairs, quality assurance, policy and procedures and training programs.

Ms. McCoy possess a considerable understanding of FDA regulations related to human cells, tissue and cellular and tissue based products and current good tissue practices. She has developed policies and procedures to comply with current regulations, lead multiple FDA inspections and has experience in FDA reporting of adverse reactions and deviations.


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