The Center for Professional Advancement, Amsterdam
27-28 September 2007
Who Should Attend:
This course has been designed to benefit those in the Pharmaceutical industry with responsibilities related to the design, operation or management of the overall Quality System or any individual quality system used by the industry. The course is particularly suitable for personnel working in:Site & Corporate Management
Production
Regulatory Affairs
Pre-Market Departments
Quality Units (including QA, QC & Quality Audit) The course is applicable to personnel in API, commodity and outsource suppliers to the industry in addition to those in primary manufacturers of drug products.
Description:
The draft of ICH Q10 is the latest document that aims to define the requirements for a quality system for pharmaceutical operations. It discusses how the function of the system should evolve during pre-market operations, what its function is when a drug is marketed and how opportunities for product improvement should be identified and implemented throughout the product life cycle. The main element discussed in Q10 is what management, especially senior management, should be responsible for in assuring an effective Quality System. Other important elements receiving an emphasis in Q10 are the Quality System components such as change control, deviation control, CAPA, root cause determination, input/process/output monitoring, product reviews and documentation. This course analyzes the content of Q10 and compares it with previous standards including the FDA Guidance on Quality Systems and ISO 9000. It analyzes its relationship with Q8 (Product Development) and Q9 (Risk Management) and the FDA Guidance on their Six-Systems Inspection Program and discusses the quality systems to which Q10 refers with particular reference as to how such systems can be effectively managed & integrated in accordance with Q10. Throughout the course interactive discussion on this new, most important and far reaching Guideline will be encouraged.
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