Documentation Requirements for Master and Working Cell Banks

Instructor: Debra Barngrover
Product ID: 704030
  • Duration: 60 Min

recorded version

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Read Frequently Asked Questions

This training program will prepare attendees for new regulatory requirements that will arise and apply to your cell line, even if it was made before the requirements were in place. One of the first steps in a recombinant project is the development of the cell line to produce the protein of interest, generally years before the product will be filed for licensure. How do you peer into the future to make sure that when the day comes to file for approval that you have collected and saved all the necessary information on that cell line and your master and working cell banks? Don’t make the mistake of assuming that you can find all that information years from now – create a plan to ensure everything is documented and saved.

Why Should You Attend:

A few other questions the session will address include:

  • Will the development of my cell line and production of the master and working cell banks be acceptable by regulatory authorities?
  • Since most of the guidances related to cell line development are more than 15 years old, are there current regulatory expectations that are not covered in the available guidances?
  • What do I need to look for if we are in-licensing a cell line from another company?
  • What will happen if some crucial piece of information can’t be found?

Areas Covered in the Webinar:

  • Why documentation of cell history is needed
  • What information and documents need to be collected
  • When to collect and review this information
  • Heads up! – New requirements from the FDA

Who Will Benefit:

This webinar will benefit people working in:

  • Regulatory roles, especially regulatory CMC
  • Recombinant product development
  • Quality assurance
  • Project management

Instructor Profile:

Debra Barngrover, PhD, is a senior consultant with the Biologics Consulting Group and has over 30 years of experience in the biopharmaceutical industry. At BCG, she has authored and reviewed several CMC BLA and IND submissions, conducted facility audits and due diligence visits, and prepared regulatory and development strategy plans.

Prior to BCG, Ms. Barngrover was vice president, technology development, at Genzyme Corporation. During her tenure at Genzyme, she led the process development team for a recombinant protein from initial product concept through approval to market launch in over 40 countries, as well as managing the technology development group responsible for development of more than 15 small molecule, protein and viral vector products. She has provided managerial leadership to process development, analytical, formulation development, project management, manufacturing, package and label engineering and risk management functions.

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