Webinars >>FDA Regulations
Good Tissue Practices and GMP for HCT/P and Stem Cell Therapies
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:
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:
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