Sep 29, 2023   SOURCE: BusinessWire

Raw Material Requirements (Health Canada/USP/EP) in a cGMP Environment - Issues and Solutions Training Course - ResearchAndMarkets.com

The "Raw Material Requirements (Health Canada/USP/EP) in a cGMP Environment - Issues and Solutions Training Course" has been added to ResearchAndMarkets.com's offering.

Explore raw material requirements, including the significant impact of water (the largest raw material in most processes), while ensuring compliance with cGMP guidelines such as ICH Q7, Q9, and Q11.

Content Highlights:

  • Comparisons between FDA, Health Canada, ICH, USP, and EP requirements.
  • Discussions on various issues related to raw materials, including testing requirements, compendial vs. non-compendial testing, regulatory risks, and more.
  • Real-life case studies, including warning letters, to highlight regulatory issues concerning raw materials.

The objective of this online two-day highly interactive seminar 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.

Upon completing this course on raw material requirements in a cGMP environment participants will:

  • Understand how various types of raw materials may impact the user.
  • Learn of 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.
  • Appreciate the requirements for Phase 1 through commercial manufacturing - why safety is required as part of Phase 1
  • Initiation of additional testing -- when?
  • Examination of regulatory risk to include ICH Q7, Q9 and Q11.
  • Why use compendial testing in lieu non-compendial testing.
  • Testing requirements -- when is enough?
  • Understand packaging and storage requirements and their impact on incoming materials to include both raw materials and API.
  • The impact of ASQ vs. square root of N+1 on sample size and attribute testing.

Agenda:

Day 1: Focus on raw material types, their impact, regulatory requirements, and the significance of additional testing.

  • Compare and Contrast FDA, Health Canada, ICH, USP and EP requirements.
  • The various raw materials and the user impact
  • Impact of raw materials in the timely production of a product
  • The impact of the single most used raw material in large molecule production and its impact upon the user
  • The regulatory requirements for Phase 1 through commercial manufacturing
  • The use of additional testing - does one only review the C of A

Day 2: Delving into compendial testing, regulatory risks, sampling and testing procedures, and analyzing case studies.

  • The use of compendial testing in lieu of non-compendial testing - pros and cons
  • Regulatory risk (ICH Q9) with raw materials
  • Testing requirements - how to sample
  • Testing requirements - how to test
  • The impact of ASQ and the square root of N+1 on sample size and attribute testing
  • Case Studies - Time to apply the previous two days
  • Warning Letter examples

Key Speaker: Dr. Barry A. Friedman, a consultant from Cambrex Bio Sciences with over three decades of experience in biopharmaceuticals and medical devices.

  • Background: Dr. Friedman has been associated with various prominent organizations in the past, like Cambrex Bio Sciences, Chesapeake Biological Laboratories, W.R. Grace, Sigma Chemical Co., and more. He has an academic background in Microbiology and Microbial Genetics from Ohio State University and Michigan State University, respectively.

For more information about this training visit https://www.researchandmarkets.com/r/q9jmti

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