Raw Material Requirements (FDA/Health Canada/ICH/USP/EP) in a CGMP Environment: Issues and Solutions - New Course

Washington, DC
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Time: 8:30 a.m. – 4:00 p.m.
Duration: 2 Days

Raw material requirements in a CGMP environment are often overlooked as a company develops new products. Depending upon the product being developed (e.g., tablets and capsules vs. biotechnology products to include recombinant microorganisms and gene therapy products), as few as fifteen to twenty, or as many as sixty raw materials, need to be sourced before the process can be moved from initiation through completion. This highly interactive two-day course on raw material requirements in a CGMP environment will:

  • Consider FDA, Health Canada, ICH, USP and EP requirements
  • Examine a variety of the issues surrounding raw materials to include what materials should be tested and to what extent during Phase 1, 2, 3 and commercial production
  • Cover testing requirements during each Phase (Phase appropriate), to include microbial and endotoxin, and what may be optional (regulatory risk) until the product moves to its next Phase
  • Determine what options exist - even within a Phase 2 or Phase 3 testing framework
  • Discuss compendial vs. non-compendial testing and how to respond when no method is available
  • Discuss how a 90 percent vs. a 90.0 percent minimum purity analysis can delay initiation of testing
  • Explore the number of lots required for testing before reduced testing might occur and why some companies don't accept this route
  • Review the use of individual samples vs. composite samples for testing
  • Explore ASQ testing to include how to choose attributes and sample size

The objective of this two-day highly interactive course is to explore raw materials and their requirements – issues and solutions. It will also explore how water impacts the final product, since water is the single largest raw material that is used within most processes. Another objective is to assure that your organization is maintaining itself within a CGMP compliance framework to include ICH Q7, Q9 and Q11. Case studies to include Warning Letters will be discussed to illustrate regulatory raw material issues.

Who Should Attend

Those who will benefit will include:

  • Quality professionals
  • Regulatory professionals
  • Compliance professionals
  • Manufacturing engineers
  • Quality engineers
  • Quality auditors
  • Quality Control
  • Microbiology
  • Document control specialists
  • R & D

More information coming soon.

Day 1

Upon completion of this course, you will be able to:

  • Explain how various types of raw materials may impact the user
  • Discuss the impact of raw materials to include any bacterial and endotoxin issues in the timely production of a product
  • Determine the single most used raw material in large molecule production and what it means to the user
  • Find the sources of analyses assistance for raw materials
  • Summarize the requirements for Phase 1 through commercial manufacturing—why safety is required as part of Phase 1
  • Discuss the initiation of additional testing -- when?
  • Examine regulatory risk to include ICH Q7, Q9 and Q11
  • Discuss why use compendial testing in lieu non-compendial testing
  • Examine testing requirements -- when is enough?
  • Explain the impact of ASQ on sample size and attribute testing
Agenda is subject to change.

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Renaissance Washington D.C. Hotel

999 9th Street, NW
Washington, DC , United States

Barry Friedman, PhD, Consultant, Barry A. Friedman, PhD, LLC