Control of Starting Materials for Biologics Products – Why is this Critical?

Event Information
Product Format
Prerecorded Event
Presenter(s)
Length
60 minutes
Product Description

Learn to Identify, Control & Protect the Critical Parts, Materials & Processes in the Creation of Biologics Products

Did you know that most cell substrates that are the source for bio-pharma products today originate from research labs at universities? Since these source cells are not as extensively controlled to the level of scrutiny of government regulators, it is the drug sponsor’s responsibility to control, characterize, and document these activities.

Contamination of cell or viral banks, and/or raw materials (i.e., culture medium) can be devastating to your program resulting in millions of dollar in losses and huge time commitments for restoration. Equally devastating is the catastrophic loss of cell or viral banks when stored in a single facility that experiences a fire, earthquake, or any other calamity. This too can cause resulting losses that runs into millions of dollar. For a small bio-pharma firm this can mean the difference between living another day or not – literally.

This program by expert speaker Benjamin Del Tito will share knowledge on how you can identify, control and protect the critical parts, materials and processes in the making of biologics products. Further, it will give you guidance to understand the compliance requirements for the ICH and FDA, and outline the regulatory expectations. Plus, you’ll get common technical documents for reference.

Learning Objectives

  • Identify critical components of biologics starting materials
  • Discuss important aspects for control of starting materials
  • Understand the testing and process control strategy to assure proper control of starting materials
  • Review the regulatory guidance provided for dossier submissions
  • Outline the regulatory expectations for control of starting materials
  • Understand ICH and FDA guidelines and guidance.
  • Get access to common technical documents for reference.

Who should attend

  • Professionals involved in biologics (i.e., monoclonal antibody, therapeutic protein, and vaccine or gene therapy product) development program.
  • Professionals involved in filing an Investigational New Drug Application (IND), New Drug Application (NDA) or Biologics License Application (BLA) for review and ultimate approval by the US Food and Drug Administration (FDA).
  • All professionals involved in research or development, manufacturing, technical services, process development, analytical development, quality control, quality assurance and regulatory affairs. 

At the Q&A session following the live event, ask a question and get advice unique to your situation, directly from our expert speaker.

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About Our Speaker

Benjamin Del Tito

Ben joined Biologics Consulting Group, Inc. in March 2015 as a Senior Consultant (Quality & Regulatory Affairs) with thirty-plus years of experience in both large pharmaceutical and small to mid-sized biotechnology companies specializing in a range of products from protein therapeutics to vaccines to diagnostics. His career has focused on the areas of analytical development, quality control, pre-clinical assay development and validation, quality assurance, and regulatory affairs. He...   More Info
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