RAW MATERIAL REQUIREMENTS (HEALTH CANADA/USP/EP) I 2015 - Raw Material Requirements (Health Canada/USP/EP) in a cGMP Environment - Issues and Solutions: 2-day In-person Seminar
Website http://bit.ly/13z91pA |
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Category FDA GXP Compliance - Pharmaceuticals;
Deadline: January 29, 2015 | Date: January 29, 2015-January 30, 2015
Venue/Country: Orlando, United Arab Emirates
Updated: 2014-12-23 15:37:37 (GMT+9)
Call For Papers - CFP
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. Who Will Benefit:Quality professionalsRegulatory professionalsCompliance professionalsManufacturing engineersQuality engineersQuality auditorsQuality ControlKeywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
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