When: |
|
28 Feb through 01 Mar 2022 |
Where: |
|
|
Website URL: |
|
|
Sponsoring organization: |
|
Compliance Online
|
|
|
-
|
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...
Read more
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 |
167 views
Placement:
Not-featured (How do I make my event featured?)
Flag
(Report this event)