2014 - FDA Regulation of Human Cells, Tissues and Cellular and Tissue-Based Products

Instructor: Mukesh Kumar
Description:
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 IND and BLA regulations before being allowed to market. Recently FDA issued Warning Letters to some 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 Some products have even been withdrawn from market due to FDA action.
This seminar will highlight the key elements of rules governing HCT/Ps 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.
Why Should you Attend:
If you involved in HCT/Ps, you should be aware of the increased scrutiny from FDA regarding manufacturers in terms of increased audits, Untitled Letters, and product recalls. 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 for assuring ongoing compliance status using case studies.
Objectives of the Presentation:
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 can 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
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