Good Tissue Practices and GMP for HCT/P and Stem cell Therapies
Date: February 12, 2025
Duration: 60 Minutes
Time: 12 PM EST
- 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
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.
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
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.
Webinar material will be uploaded on the website 24 hours before the scheduled date of the webinar. In case it is not available on the website due to some technical issues, we will email the material a few hours before the start of the webinar.
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.
