FDAnews Announces — HCT/P Donor Compliance Risks: Best Practices for Testing, Screening and Determining Eligibility Webinar, May 28, 2015

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FDAnews has partnered with David Smith of Pepper Hamilton for an analysis of the FDA’s current inspection and enforcement actions regarding 21 CFR part 1271, subpart C which requires human cells, tissues, and cellular and tissue-based product (HCT/P) establishments to properly determine donor-eligibility, including donor screening and testing. David, recognized as an industry expert in HCT/P donor eligibility and tissue ownership issues, will detail how HCT/P establishments can self-audit and assure they will not be in the FDA’s cross-hairs during their next inspection.

HCT/P Donor Compliance Risks:
Best Practices for Testing, Screening and Determining Eligibility
**FDAnews Webinar**
May 28, 2015 — 1:30 p.m. – 3:00 p.m. EDT
http://www.fdanews.com/HCTPDonorCompliance

The FDA has been busy enforcing 21 CFR part 1271, subpart C which requires human cells, tissues, and cellular and tissue-based product (HCT/P) establishments to properly determine donor-eligibility, including donor screening and testing.

HCT/Ps must not be transferred, implanted, transplanted or infused until the donor has been determined to be eligible.

FDAnews has partnered with David Smith of Pepper Hamilton for an analysis of the FDA’s current inspection and enforcement actions regarding 21 CFR part 1271, subpart C which requires human cells, tissues, and cellular and tissue-based product (HCT/P) establishments to properly determine donor-eligibility, including donor screening and testing. David — recognized as an industry expert in HCT/P donor eligibility and tissue ownership issues — will detail how HCT/P establishments can self-audit and assure they will not be in the FDA’s cross-hairs during their next inspection.

During this 90 minute presentation attendees will learn:

  • What the most common red flags FDA investigators look for as they inspect your files during an inspection
  • Best practices for testing suspect HCT/P product to assure it is ready for release
  • Tips for creating eligibility screening checklists that match the requirements of 21 CFR part 1271, subpart C
  • Who should be involved in the decision making — and what documentation should exist — when releasing a previously quarantined product
  • How to write SOPs that teach employees the importance of and proper action when dealing with departures from procedures situations. This is a common FDA inspectional observation finding.
  • How the FDA expects a “responsible person” to act on issues where there are concerns about product eligibility or risks of communicable disease transmission. Should this person be an employee, independent outsider or a committee?

Meet the Presenter:
David Smith, Counsel, Pepper Hamilton LLP
David Smith is a nationally renowned lawyer focusing on intellectual property transactions, venture financings and regulatory matters for life sciences companies and investors. Mr. Smith’s corporate practice is concentrated in the organization and growth of life sciences companies, and he is an authority on the legal issues surrounding the use of human biological materials. Mr. Smith’s intellectual property-related work includes IP transactions, regulatory issues and licensing.

Who Will Benefit:

  • Medical affairs professionals
  • Regulatory affairs professionals
  • Compliance personnel
  • QA/QC personnel
  • Senior management
  • In-house and outside counsel
  • Professionals new to HCT/Ps

Conference Details:
HCT/P Donor Compliance Risks:
Best Practices for Testing, Screening and Determining Eligibility
**FDAnews Webinar**
May 28, 2015 — 1:30 p.m. – 3:00 p.m. EDT
http://www.fdanews.com/HCTPDonorCompliance

Tuition:
$287 per site

Easy Ways to Register:
Online:     http://www.fdanews.com/HCTPDonorCompliance
By phone: 888-838-5578 or 703-538-7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

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Michelle Butler
FDANEWS
+1 (703) 538-7665
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