Good Tissue Practices and GMP for HCT/P and Stem cell Therapies

Date: February 12, 2025
Duration: 60 Minutes
Time: 12 PM EST

Good Tissue Practices (GTP) and Good Manufacturing Practices (GMP) are the core FDA requirements for manufacturing products regulated as Human Cells, Tissues and Cellular and Tissue-Based Products (HCT/Ps) and cellular therapies. 21 CFR 1271 rules provide the basic outline of FDA expectations but detailed instructions lack. GTP and GMP regulations are designed to assure high quality cellular and tissue products while maintaining control of potential infections, contaminations and other risk factors with such products. GTP and GMP also define the core elements of operational control and documentation required for manufacturers of such products. All personnel involved in manufacture of autologous, allogeneic and homologous cellular and tissue products must be trained in GTP and GMP and be constantly supervised for compliance. Deficiencies in GTP and GMP compliance can lead to FDA Warning Letters, sanctions and other punitive actions on the manufacturers of such products. This seminar will discuss the core elements for GTP and GMP, with practical tips for compliance.

Areas Covered in the Session:

Core GTP and GMP requirements for HCT/Ps and cellular therapies
Training requirements
Documentation requirements
QC and QA processes for GTP labs
GLP and GMP aspects applicable to cellular therapy labs
Common FDA audit findings for GTP/GMP manufacturing sites
Best practices for addressing audit findings and negotiations with FDA

Why should you attend:
This seminar, presented by the industry’s leading GTP expert, will highlight the key elements of GTP and GMP 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. Common FDA audit findings and potential solutions will be discuss to highlight how to avoid trouble to start with. 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 to assure ongoing compliance status.

Who will benefit:
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

For more info, fill the box below. We will contact you within 24 hrs.

Webinar Fee

Single Registration

$199

Group Registration (5 Persons)

$699

Group Registration (10 Persons)

$1199

Prices are in US Dollars.
The registration fee includes: The live webinar & all related course materials.

Terms & Conditions to register for the Webinar

Your Registration for the workshop is subject to following terms and conditions. If you need any clarification before registering for this webinar please email us at info@fdamap.com

Payment

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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.

On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($30) will be transferred to any future FDA Map event and a credit note will be issued. No-shows will be charged the full amount.

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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.