Development and Marketing of Human Cells, Tissues and Cellular and Tissue-Based Products (HCT/Ps) In the US
Date: April 30, 2025
Duration: 60 Minutes
Time: 12 PM EST
This seminar will highlight the key elements of rules governing HCT/Ps using case studies. Practical suggestions for compliance with the FDA requirement along with tips to negotiate with the agency regarding disputes with interpretation of the law will be discussed.
If you involved in HCT/Ps, you should be aware of the increased scrutiny from FDA regarding manufacturers in terms of increased audits, Untitled Letters, and product recalls. This seminar will provide a summary of the existing rules, the common complaints from FDA, ways in which companies have tried to comply and practical tips for assuring ongoing compliance status using case studies.
- 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
This webinar will provide valuable assistance to all personnel in:
- Managers and owners of HCT/P marketing companies
- Regulatory and quality professionals working in HCT/P manufacturing sites
- 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
Speaker: Mukesh Kumar
PhD, RAC | CEO, FDAMap

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Webinar Fee
Prices are in US Dollars.
The registration fee includes: The live webinar & all related course materials.
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Cancellations & Substitutions:
Written cancellations through fax or email (from the person who has registered for this conference) received at least 5 business days prior to the start date of the event will receive a refund — less a $30 administration fee. No cancellations will be accepted — nor refunds issued — within 5 business days before the start date of the event. You may however, choose to substitute the webinar for which you are registered with some other webinar in the future.
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In the event FDA Map cancels the webinar, FDA Map will issue a full refund to all the registrants for that webinar. Some topics and speakers may be subject to change without notice.