Raw Material Requirements (Health Canada/USP/EP) in a cGMP Environment - Issues and Solutions

  • 2025
  • United States

Description

Raw Material Requirements (Health Canada/USP/EP) in a cGMP Environment - Issues and Solutions is a seminar that addresses the raw material requirements in a cGMP environment.

Raw Material Requirements (Health Canada/USP/EP) in a cGMP Environment - Issues and Solutions covers topics such as:

  • FDA, Health Canada, ICH, USP and EP requirements
  • Latest updates to include FDA, Health Canada, ICH, USP and EP requirements
  • 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
  • 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
  • What options exist - even within a Phase 2 or Phase 3 testing framework
  • Compendial vs. non-compendial testing and how to respond when no method is available
  • How a 90 percent vs. a 90.0 percent minimum purity analysis can delay initiation of testing
  • The number of lots required for testing before reduced testing might occur and why some companies don`t accept this route
  • The use of individual samples vs. composite samples for testing
  • Packaging and storage requirements and their impact on in-coming materials to include both raw materials and API
  • ASQ testing to include how to choose attributes and sample size
  • When the ASQ vs. square root of N+1 is appropriate

Raw Material Requirements (Health Canada/USP/EP) in a cGMP Environment - Issues and Solutions brings together:

  • Regulatory professionals
  • Quality professionals
  • Manufacturing engineers
  • Compliance professionals
  • Quality auditors
  • Quality engineers
  • Microbiology
  • Quality Control
  • Document control specialists
  • In-coming Materials
  • Project Managers
  • R & D

Raw Material Requirements (Health Canada/USP/EP) in a cGMP Environment - Issues and Solutions might be held in United States in 2025.

More Details

Prices:
1499-1899 US Dollar (Estimated)
Exhibition:
No exhibition
Organizer:
ComplianceOnline
Website:

Future Events

Past Events

Important

Please, check "Raw Material Requirements (Health Canada/USP/EP) in a cGMP Environment - Issues and Solutions" official website for possible changes, before making any traveling arrangements

Event Categories

Business: Quality assurance
Health & Medicine: Pharma

Other Events with Similar Categories

Other Events with Similar Location or Organizer

Featured Conferences & Exhibitions