|Level: Advanced - Application
ISPE CEUs: 1.5
Type: Classroom Training Course
|This course is not currently scheduled, but may be offered at your company site. Please contact ISPE for more information.|
This highly interactive workshop gives participants hands-on experience in applying practical techniques and solutions to solve computerized systems compliance challenges. Participants will discuss and analyze case studies, apply newly acquired knowledge to hypothetical case-study systems, and have the opportunity to discuss their own real-life challenges with other participants and an expert trainer. Participants should come prepared to work in groups to devise workable and creative solutions to realistic problems and case study scenarios, facilitated by the instructor.
Immediately apply the course learning objectives using the complimentary copy of the GAMP® 5 Guide: A Risk-based Approach to Compliant GxP Computerized Systems.
Highlights of the course include:
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 includes a pre-recorded Webinar that provides a review of the basics prior to the classroom course. Access information will be provided via email one week prior to the start of the training event.
This Training course is of particular interest to existing and future members of the ISPE GAMP® Community of Practice (COP)
This course contains knowledge related to the CPIP™ technical knowledge competency elements Quality Systems: Systems Validation and Information Systems. 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 available for download in your ISPE account a 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.