When: |
26 Aug 2021 through 27 Aug 2021 | |
Where: |
Online Event | United States | |
Website URL: |
https://www.complianceonline.com/raw-material-requirements-health-canada-usp-ep-in-a-cgmp-environment-issues-and-solutions-seminar-training-80218SEM-prdsm?channel=Brownwalker | |
Sponsoring organization: |
Compliance Online | |
Categories: |
Medicine & Health - Pharmaceutical / Medicinal |
Keywords:
Event description:
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 seminar on raw material requirements in a cGMP environment will:
Compare and Contrast FDA, Health Canada, ICH, USP and EP requirements
Review latest updates to include 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...
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Posting date:
19 August 2021 | 205 views
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