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.
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?
Who Will Benefit:
This webinar will benefit people working in:
Regulatory roles, especially regulatory CMC
Recombinant product development
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.
Use coupon code 232082 and get 10% off on registration.