FEB 28

Raw Material Requirements

   

Seminar/trade show (noCPF)

  

 

When:

  28 Feb 2022 through 01 Mar 2022

Where:

  Online Event

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

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 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. 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 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. Who Will Benefit: Those who will benefit from this ON-LINE seminar include: Quality professionals Regulatory professionals Compliance professionals Manufacturing engineers Quality engineers Quality auditors Quality Control Microbiology In-coming Materials Document control specialists

Posting date:

26 November 2021
views | 1 subscribers | Be the first to rate this event

Placement:

Not-featured (How do I make my event featured?)