CMC Requirements for Cell and Gene Therapy

Duration: 90 Minutes
Cell and gene therapy is an exploding area of new technology and innovation in the pharmaceutical industry. Mapping of the human genome that led to discovery of pathways for intervention in disease states drives this innovation in drug development. Many of these discoveries are improving the prognosis of diseases that previously had no therapeutic intervention. As more customized therapeutics and cell-specific therapeutics are developed for use in treating a variety of diseases, FDA Guidance for Industry Documents play a key role. Regulatory expectations are still an important part of the process. These regulatory documents are necessary to ensure quality and safety parameters are established and met. This webinar will address the impact of this new technology and the response of the FDA toward regulating quality and safety.
Cell and Gene Therapy
Product ID: 508889
Objectives of the Presentation
  • Responsible agencies for regulation
  • Understanding the drug approval process
  • Definition of cell and gene therapy
  • Risk assessment
  • Implementing processes for safety and quality
  • Challenges in characterization of products
  • GMP/GLP/GTP
Why Should you Attend
Stem cells, as well as transfected/transformed cells, are powering significant breakthroughs in medicine. The FDA has been guarded in response to applications for this type of therapy. Due to the need to provide understanding of the regulatory process, the FDA released numerous updated guidance documents. These guidance documents provide information on production through deviation reporting and evaluation of medical devices used in delivery. Companies’ currently developing cell and gene therapeutic agents should take this webinar to gain knowledge to address pertinent issues in manufacturing, assessment, and use of cell or tissue based products.

Areas Covered
  • Overview of cell and gene therapy
  • Regulatory agency guidelines
  • Determining regulatory status
  • Minimal manipulation / homologous use
  • Process steps
  • Critical quality attributes
  • Labeling
  • Problems and pitfalls
  • Deviation reporting
  • FDA inspections and enforcement
Who will Benefit
  • Research and Development Scientists
  • Quality Control
  • Quality Assurance
  • Regulatory Affairs
  • Clinicians
  • Compliance Professionals
  • Academic Researchers
  • Production Supervisors
  • Medical Affairs
  • Process Developers
  • Production Engineers
Topic Background
Cell therapy and gene therapy is a new technology that is helping patients with previously untreatable diseases. The increase in viable cell and gene therapies necessitated regulatory guidance documents to ensure processes were implemented that assure quality and safety of this new technology. As the landscape changes and new regulations are implemented those who are manufacturing or treating patients with these new technologies should stay up-to-date on recent regulatory changes. This webinar addresses regulatory expectations as well as provides an overview of cell and gene therapy.

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  • 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
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  • 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:
Gwendolyn Wise-Blackman is a successful scientist/manager with increasing accountability for scientific expertise and budget in the pharmaceutical industry, including managing multiple projects. She has working knowledge of FDA/ICH GLP and GMP guidelines and has proven experience with cell-based potency assays, Cell-based neutralization assays, PK and immunogenicity ELISA used to support bioprocess techniques for large molecule therapeutics. Ms. Wise-Blackman also holds Research & Development expertise in High Throughput Screening, 7-transmembrane receptor binding assays, cell-based assays, cell culture, and ELISA. Ms. Wise-Blackman is gifted with excellent presentation skills as evidenced by numerous scientific speaking engagements and working knowledge of PMP principles. She was an invited lecturer for IBC and IVT conferences, 1999-2008.
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