Webinars >>FDA Regulations
Good Tissue Practices and GMP for HCT/P and Stem Cell Therapies  
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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:
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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
Date: October 8, 2019
​Duration: ​60 Minutes
Time: 12 PM EST

Speaker: Mukesh Kumar
PhD, RAC | Brij Strategic Consultations,  USA

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For additional information on the workshop agenda and logistics, please call 410-501-5777 or email: info@fdamap.com