GAMP® Good Practice Guide: Manufacturing Execution Systems - Guide Launch (D01)
Sponsored by the GAMP® Community of Practice.
This seminar will launch the new GAMP® Good Practice Guide: Manufacturing Execution Systems, A Strategic and Program Management Approach, which features how to develop and implement an integrated systems program based on a technology-independent structure and methodology. Attend this one-day seminar to learn how a company can apply a functional strategy to specify, verify, and manage all relevant system/ application capabilities through the ISA hierarchy instead of a single-application approach. See how a company can assess the current state and define the manufacturing-related systems domain using existing and/or new systems/applications to contribute to lean design and a higher assurance of compliance. A panel discussion among speakers and attendees will allow for an interactive exchange of ideas. This is a Good Practice Guide launch; registrants will receive a copy of this guide. Attendees will see practical industry examples that help decrease risk, and have the potential to save money by optimizing current resources and system functionality. This one-day seminar will walk through a methodology to assess what you have and what you want to accomplish -- before investing in expanded or new technical capabilities.
How You Will Benefit
At the conclusion of this session, participants will be able to:
- Understand how to produce and document a computer integrated manufacturing (MES) strategy that will ensure that the user organization has an efficient, compliant, system that will establish a steady state in the company
- Plan an effective program ensuring that effective MES support governance is in place including risk and
- Describe EPR (Electronic Production Records), Electronic Batch Records (EBR), Review By Exception (RBE), and Electronic Work Instructions
Who Should Attend
Program and project managers, senior stakeholders responsible for strategy, engineers, IT, operations and quality personnel involved with specifying or verifying systems functionality affecting manufacturing, or linking the enterprise and laboratory systems to the shop floor
Communities of Practice (COPs)
Knowledge Elements Addressed in the Guide Document
- 1 - Product Development
- B. Technology transfer
- 2 - Facilities and equipment
- D. Controls and automation
- 3 - Information systems
- 4 - Supply chain management
- A. Materials management
- 5 - Production systems
- A. Production unit operations - drug (small molecule) and biologics
- B. Production management
- 6 - Regulatory compliance (includes drugs, environmental, health and safety)
- B. Standards, practices, and guides
- 7 - Quality systems
- A. Risk management and Quality Management System (QMS)
- B. Systems validation (changed from Validated Controls)
Related Technical Docs and/or PE, JPI articles
- GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems (Fifth Edition, February 2008), Appendix S2
- MES article PE May/June 2008, deSpautz and Ruklic
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 sent via email within four weeks of evaluation materials. One hour of education programming equals 0.1 ISPE CEU credits.