FDA Regulation of Human Cells, Tissues and Cellular and Tissue-Based Products (HCT/Ps)

Instructor: Mukesh Kumar
Product ID: 703652
  • Duration: 90 Min
This webinar will highlight rules governing HCT/Ps using case studies. Practical suggestions for compliance with FDA requirements and tips to negotiate with the agency regarding disputes with interpretation of the law will form the core of this training session.

recorded version

1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Jul-2015

Training CD / USB Drive

One CD/USB is for usage in one location only.
(For multiple locations contact Customer Care)
CD/USB and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-362-2367

Email: customercare@complianceonline.com

Read Frequently Asked Questions

Why Should You Attend:

If you are looking for expert guidance on regulations governing human cells, tissues and cellular and tissue-based products (HCT/Ps), this webinar will present an exclusive summary of current regulations and also detail tips to stay compliant and avoid FDA warning letters during audits.

This webinar will also:

  • Summarize existing rules
  • Enumerate common complaints from FDA
  • Discuss ways in which companies have tried to comply
  • Offer practical solutions to stay compliant

Areas Covered in the Webinar:

  • Current regulations for HCT/Ps and review of 21CFR 1271
  • GMP and GTP for HCT/Ps
  • Procedures for registration and listing
  • Common FDA audit findings for HCT/P manufacturing sites
  • Best practices for addressing audit findings and negotiations with FDA

Who Will Benefit:

Those involved in HCT/Ps should be aware of FDA’s increased scrutiny regarding manufacturers in terms of increased audits, untitled letters, and product recalls. The individuals who will benefit from this webinar include:

  • Managers and owners of HCT/P marketing companies
  • Regulatory and quality professionals working in HCT/P manufacturing sites
  • Employees in hospital and clinics using HCT/Ps
  • Regulatory, compliance and quality professionals consulting with HCT/P companies
  • Medical insurance and reimbursement professionals
  • Physicians and consumers using HCT/Ps

Instructor Profile:

Dr. Mukesh Kumar is a Washington DC-based consultant in regulatory affairs and quality assurance for manufacturers and developers of FDA-regulated products. He leads the regulatory affairs and quality assurance departments at Amarex, a full service pharmaceutical product development company based in Germantown, MD. His key expertise is in regulatory affairs, clinical trials and multi-national project management for medicinal and diagnostic products. He has been involved in over 100 clinical trials in more than 40 countries, has made hundreds of US FDA submissions, and arranged a number of meetings with the US FDA. In addition, he has made regulatory submissions in the EU, Taiwan, Korea, China, Canada, countries in South America, Australia, and India. He has conducted GCP, GLP, GMP and GACP audits in the US and several countries in Europe, North and South Americas and Asia.

Dr. Kumar has conducted numerous training workshops in FDA compliance related issues. He has authored numerous articles in peer-reviewed journals. He is a well-known expert in global regulatory affairs and has been an invited speaker in several professional and academic organizations worldwide. Dr. Kumar has a PhD in Biochemistry and is a certified regulatory affairs professional by the Regulatory Affairs Professional Society, USA.

Topic Background:

Companies manufacturing products derived from human cells and tissues for autologous implantation, transplantation, infusion or transfer of human cells and tissues for therapeutic purposes are allowed to market their products without a formal marketing approval under a BLA provided they meet certain conditions that define the permitted good manufacturing and tissue handling practices, labeling and shipping, inter-state commerce and marketing claims. Products that do not meet the strict criteria set by FDA are subject to the Investigational New Drug (IND) and Biologics License Application (BLA) regulations before being allowed to market. Recently FDA issued warning letters to a few companies marketing HCT/Ps citing major modification to human cells and tissues and asked to initiate a formal investigation under an IND and marketing approval. Some products have even been withdrawn from the market due to such FDA action.

Follow us :

Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email customercare@complianceonline.com call +1-888-717-2436 (Toll Free).

Product Reviews

This product hasn't received any reviews yet. Be the first to review this product! Write review

Best Sellers
You Recently Viewed