ISPE CEUs: 1.3
Type: Classroom Training Course
Due to the growing pressures from global competitors, high marketing demands, and the requirements of GMP compliance, the bio-pharm industry (brand drugs and generic drug companies) are looking beyond the usual group of closely-knit suppliers. India and China engage in bulk actives and have been generating new dimensional API products with more specialized capabilities than those required by traditional drug products. In order to remain competitive, API manufacturers will need to attune themselves to this evolving dynamic global market.
This course covers areas in which compliance requirements differ most from traditional pharmaceuticals and biologics and will review common deficiencies and problem areas related to the ICH Harmonised Tripartite Guideline Good Manufacturing Practice Guide For Active Pharmaceutical Ingredients Q7 and the USFDA's interpretation of ICH Q7, as defined in Q7A, the Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients.
The course also discusses the manufacturing equipment system and engineering practice and compliance issues. Participants will learn key regulatory information and practical utilization techniques to develop the ability to ask the right questions based upon science and the regulations knowing the relationship between this quality guidance for the production of APIs, and GMP regulations applicable to the production of pharmaceutical and biologic finished drug products.
Note: We recommend participants have a basic understanding of the GMP regulations and API manufacturing operations
Professionals in quality assurance, quality control, DS (drug substance) development and manufacturing, plant management and production managers/supervisors, maintenance/utility engineers for facility/utility systems and production systems. Design engineers for manufacturing equipment and control systems, design/installation/CQV and regulatory inspectors related to the production of API.
This training course is of particular interest to existing and future members of the ISPE Active Pharmaceutical Ingredients Community of Practice (COP).
ISPE will provide continuing education units (ISPE CEUs) for all North American and European courses. CEUs are nationally recognized units of achievement designed for those individuals continuing their education in their chosen field or profession. Verification of CEUs is based on attendance as well as satisfactory completion of all evaluation materials. Statements of credit will be available for download in your ISPE account within four weeks of the completion of training. Instruction for download will be sent when the CEUs are available. One hour of education programming equals 0.1 ISPE CEU credits.
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