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

Duration: 90 Minutes
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 Some products have even been withdrawn from market due to FDA action.
human tissue cells
Instructor: Mukesh Kumar
Product ID: 500428

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
Live Session - How it works
  • Username and Password will be sent to you 24 hours prior to the webinar
  • Presentation handouts in pdf formate will be mailed to you
  • Login to the session using the username and password provided to you
  • Get answer to your queries through interactive Q&A sessions via chat
  • Please let us know your thoughts and views at the end of webinar, your valuable feedback will help us improve
  • Get certification of attendance.
Recorded Session - How it works
  • A link will be provided to you upon purchase of the recorded session
  • Please click on the link to access the session
  • Presentation handouts in pdf formate will be mailed to you
  • Get certification of attendance.
$375
Recorded Session for one participant
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How it works
Live Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • The webinar joining link, username and password for joining the webinar will be updated on your OCP Account 24 hours prior to the webinar
  • Presentation handouts in Downloadable PDF format will be updated on your OCP Account 24 hours prior to the live session
  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Mukesh Kumar, leads the Regulatory Affairs and Quality Assurance departments at Amarex Clinical Research, a full service CRO based in Germantown, MD. His key expertise is in developing Global Regulatory Business Strategies for biomedical product development and his passion is to bring traditional therapies for India, China and the Latin-America to the Western markets. In addition to regulatory expertise, Mukesh is an experienced auditor and a trainer in regulatory and business processes.

Mukesh started his professional career as a research scientist at the NIH, Baylor College of Medicine, Houston, and several premier institutions in India. With more than 11 years of experience in virology, gene therapy, and molecular biology, Mukesh has expertise in biological and combination products. He has been a global Regulatory Affairs Specialist (US, EU, and India) for the last 5 years. He has filed several new-INDs for drugs, biologics and combinations products, NDAs, 510K, PMAs, etc. He has made several hundred FDA submissions, and arranged a number of meetings and responses to FDA comments. In addition, he has had made regulatory submission in the EU and India. Mukesh has reviewed/compiled more than 100 clinical trial protocols and has supervised more than 60 multi-national clinical trials (both under IND and non-IND trials), in the US, Canada, Latin America, Africa, and Asia. In addition to drugs and Biologics, he has extensive experience in medical device and diagnostic product regulatory filings and safety monitoring.

Specialties: Technology transfer, global regulatory strategy, global clinical trials, safety reporting, training, and GLP/GCP audits.

Honors and Awards: US patent awarded "Gene Therapy vectors derived from Sendai virus".

Education: Education: Delhi University - Ph.D., Biochemistry - 1993 – 1997
National Dairy Research Institute - MS, Biochemistry - 1990 – 1993
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