Webinars>>​FDA Regulations
Development and Marketing of Human Cells, Tissues and Cellular and Tissue-Based Products (HCT/Ps) In the US

Human cells and tissue products are widely used in replacement and regenerative therapies. Recently FDA made a major overhaul in its departments regulating HCT/Ps to match the rapid developments in the medical treatments using such products. The laws governing HCTP/Ps are described primarily in 21 CFR 1271 and PHS 361, however, the laws only provide a general outline and not specific instructions to create and market new products. Since HCT/Ps are allowed to market their products without a formal marketing approval under a BLA provided they need to meet certain conditions that define the quality of the product, labeling and shipping, inter-state commerce and marketing claims. Products that do not meet the strict criteria set by FDA are required to go through the IND and BLA regulatory pathways before being allowed to market. Non-compliance could lead to multiple punitive actions from the FDA starting with Warning Letters, product recalls and withdrawal, restrictions on sales, and even legal action.    
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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.
Topics Covered in the Session:
  • 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:

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: August 14, 2020
Time: 12 PM EST
Duration: 60 Minutes

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