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

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

Instructor Profile:

Dr. Mukesh Kumar is a Washington DC-based consultant in regulatory affairs and quality assurance for manufacturers and developers of FDA-regulated products. He leads the regulatory affairs and quality assurance departments at Amarex, a full service pharmaceutical product development company based in Germantown, MD. His key expertise is in regulatory affairs, clinical trials and multi-national project management for medicinal and diagnostic products. He has been involved in over 100 clinical trials in more than 40 countries, has made hundreds of US FDA submissions, and arranged a number of meetings with the US FDA. In addition, he has made regulatory submissions in the EU, Taiwan, Korea, China, Canada, countries in South America, Australia, and India. He has conducted GCP, GLP, GMP and GACP audits in the US and several countries in Europe, North and South Americas and Asia.

Dr. Kumar has conducted numerous training workshops in FDA compliance related issues. He has authored numerous articles in peer-reviewed journals. He is a well-known expert in global regulatory affairs and has been an invited speaker in several professional and academic organizations worldwide. Dr. Kumar has a PhD in Biochemistry and is a certified regulatory affairs professional by the Regulatory Affairs Professional Society, USA.

Topic Background:

Companies manufacturing products derived from human cells and tissues for autologous implantation, transplantation, infusion or transfer of human cells and tissues for therapeutic purposes are allowed to market their products without a formal marketing approval under a BLA provided they meet certain conditions that define the permitted good manufacturing and tissue handling practices, labeling and shipping, inter-state commerce and marketing claims. Products that do not meet the strict criteria set by FDA are subject to the Investigational New Drug (IND) and Biologics License Application (BLA) regulations before being allowed to market. Recently FDA issued warning letters to a few companies marketing HCT/Ps citing major modification to human cells and tissues and asked to initiate a formal investigation under an IND and marketing approval. Some products have even been withdrawn from the market due to such FDA action.

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