FDA Regulation of Human Cells, Tissues and Cellular and Tissue-Based Products (HCT/Ps)

This webinar will highlight rules governing HCT/Ps using case studies. Practical suggestions for compliance with FDA requirements and tips to negotiate with the agency regarding disputes with interpretation of the law will form the core of this training session.

Why Should You Attend:

If you are looking for expert guidance on regulations governing human cells, tissues and cellular and tissue-based products (HCT/Ps), this webinar will present an exclusive summary of current regulations and also detail tips to stay compliant and avoid FDA warning letters during audits.

This webinar will also:

• Summarize existing rules
• Enumerate common complaints from FDA
• Discuss ways in which companies have tried to comply
• Offer practical solutions to stay compliant

Areas Covered in the Webinar:

• 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

Who Will Benefit:

Those involved in HCT/Ps should be aware of FDA’s increased scrutiny regarding manufacturers in terms of increased audits, untitled letters, and product recalls. The individuals who will benefit from this webinar include:

• Managers and owners of HCT/P marketing companies
• Regulatory and quality professionals working in HCT/P manufacturing sites
• Employees in 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