DUBLIN--(BUSINESS WIRE)--Research and Markets has announced the addition of the "Raw Material Requirements (Health Canada/USP/EP) in a cGMP Environment - Issues and Solutions: 2-day In-person Seminar" conference to their offering.
Raw material requirements in a cGMP environment are often overlooked as a company develops new products. Depending on the product being developed, e.g., tablets and capsules vs. biotechnology 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:
- Consider Health Canada, FDA, 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 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.
- Explore the number of lots required for testing before reduced testing might occur and why some companies don't accept this route.
- Review the use of individual samples vs. composite samples for testing.
- Explore ASQ testing to include how to choose attributes and sample size.
- Understand how various types of raw materials may impact the user.
- Learn of the impact of raw materials 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.
- Initiation of additional testing - when?
- Examination of regulatory risk (ICH Q9).
- Why use compendial testing in lieu non-compendial testing.
- Testing requirements - when is enough?
- The impact of ASQ on sample size and attribute testing.
Who Should Attend:
- Quality professionals
- Regulatory professionals
- Compliance professionals
- Manufacturing engineers
- Quality engineers
- Quality auditors
- Quality Control
- Document control specialists
- R & D
For more information about this conference visit http://www.researchandmarkets.com/research/s54fk5/raw_material