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Basic Principles of Computerized Systems Compliance (GAMP® 5)
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ISPE CEUs*: 1.3 |
Upcoming Dates and Locations
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Date |
Location |
Country |
Instructor(s) |
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| 19-20 May 2008 | Brussels Training Series Brussels |
Belgium | Sion Wyn | |||
| 22-23 September 2008 | New Jersey Classroom Training Series Someret, NJ |
United States | Kate Townsend |
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| 19-20 November 2008 | San Diego Classroom Training Series San Diego, CA |
United States | Jim John | |||
Description:
This basic course introduces participants to regulatory requirements for computerized systems in the pharmaceutical industry and explores tried, tested, and internationally recognized methods of meeting those requirements. GAMP guidance provides a pragmatic and effective framework for achieving computerized systems that are fit for intended use and meet current regulatory requirements, by building upon existing industry good practice in an efficient and effective manner.
The course does not aim to cover detailed and highly technical aspects of software and hardware engineering, but rather gives the principles and an overview of the overall computer systems compliance process, including a scaleable and efficient system life cycle, quality risk management applying ICH Q9, updated GAMP categories, supplier assessment, and the selection of appropriate specification and verification activities.
The course does not aim to cover detailed and highly technical aspects of software and hardware engineering, but rather gives the principles and an overview of the overall computer systems compliance process, including a scaleable and efficient system life cycle, quality risk management applying ICH Q9, updated GAMP categories, supplier assessment, and the selection of appropriate specification and verification activities.
Course topics include:
• What are the FDA and EU regulatory requirements for GxP computerized systems?
• How do investigators approach a computer systems inspection?
• Overview of GAMP® 5 Guide: A Risk-based Approach to Compliant GxP Computerized Systems
• GAMP system life cycle and specifications - URS, FS, and design
• Key themes and concepts
• Quality risk management for computerized systems
• Computerized system validation framework - plans and reports
• Risk assessment method
• Scalable specification and verification based on risk
• Updated GAMP categories
• Role of users and suppliers – assessment and cooperation and leveraging supplier activities
and documentation
• Testing in GAMP - principles and practical approaches
• Verification approaches and qualification terminology and concepts
• Policies, procedures, and plans required for effective governance
• Pragmatic and efficient practices - cost effective compliance
• New special interest topics, including control of spreadsheets and end-user databases
• Operation, control, and maintenance of systems
Attendance Suggested For:
• Quality assurance and quality control specialists, validation specialists, manufacturing supervisors, technical support personnel, engineers, MIS professionals and all levels of management who need a fundamental understanding of computerized system compliance and regulations
• Computer system vendors or consultants, engineering contractors, and validation service companies• This Training course is of particular interest to existing and future members of the ISPE GAMP
Community of Practice (COP)
Important Course Notes:
• Participants will receive a complimentary copy of GAMP® 5.
• This course was developed by members of the ISPE GAMP Community of Practice. GAMP was
established by industry leaders to interpret and improve the understanding of regulations
governing the use of computerized systems in pharmaceutical manufacturing.
• This course contains knowledge related to the CPIPSM technical knowledge competency element Facilities and Equipment. For complete information concerning the knowledge elements or the CPIP Credential, please visit www.ISPE-PCC.org.
• This course was developed by members of the ISPE GAMP Community of Practice. GAMP was
established by industry leaders to interpret and improve the understanding of regulations
governing the use of computerized systems in pharmaceutical manufacturing.
• This course contains knowledge related to the CPIPSM technical knowledge competency element Facilities and Equipment. For complete information concerning the knowledge elements or the CPIP Credential, please visit www.ISPE-PCC.org.
ISPE will provide continuing education units (ISPE CEUs) for all North American seminars and courses, including educational programming at the ISPE Annual Meeting. CEUs are nationally recognized units of achievement designed for those individuals continuing their education in their chosen field or profession.
Delegates attending European seminars and courses will receive a Certificate of Attendance, as ISPE CEUs are currently not offered at European events. Verification of CEUs is based on attendance as well as satisfactory completion of all evaluation materials. Statements of credit will be mailed within four weeks of evaluation materials. One hour of education programming equals 0.1 ISPE CEU credits.
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