QUESTIONSComputer System Validation
Venue: Hilton Garden Inn
| Event Date/Time: May 28, 2009 | End Date/Time: May 28, 2009 |
| Registration Date: May 27, 2009 | |
| Early Registration Date: May 27, 2009 |
Report as SpamDescription
A ONE-DAY COMPREHENSIVE & INTERACTIVE COURSE & CASE STUDIES ON:
Computer Validation – Using common sense to scope validation efforts
Common compliance themes in global regulations for computer system validation – GMP, GLP, GCP, and 21 CFR Part 11
How to perform compliant computer validation as a software supplier (OQ), as an IT department (IQ), and as an end user (PQ)
Standard content for Validation Plans, Test Plans, Test Scripts, and Summary Reports
Requirement Specifications – User, Functional, and Infrastructure
Installation Qualification (IQ) approach to testing
Performance Qualification (PQ) approach to testing
Operational Qualification (OQ) approach to testing
Mitigation strategies – Disaster Recovery and Business Continuity
Risk Assessment – documenting system status as GXP or non-GXP
Saving time and money - the Master Plan approach
ABOUT THE COURSE:
The need to have computer systems operate as expected whenever they are in use is a common business concern across all work areas both regulated and non-regulated. In regulated work processes the need to document management control, system reliability, and data integrity becomes of utmost importance. This seminar day describes the common characteristics of global regulations related to computer systems and teaches a proven standards-based approach to meeting those regulations. It uses real project examples to illustrate a common sense approach to computer validation that has passed inspections and audits in North America and Europe.
Auditors and inspectors new to computer validation will see the process in its variations of OQ/IQ/PQ and examples of the types of expected documented evidence. Validation team members will see the “how to†process for their respective roles as OQ, IQ, or PQ teams. The use of a Master Plan and Forms process will be shown as a common sense approach to save time and money, yet maintain compliance for categories of systems and in-production control after go-live.
Computer Validation – Using common sense to scope validation efforts
Common compliance themes in global regulations for computer system validation – GMP, GLP, GCP, and 21 CFR Part 11
How to perform compliant computer validation as a software supplier (OQ), as an IT department (IQ), and as an end user (PQ)
Standard content for Validation Plans, Test Plans, Test Scripts, and Summary Reports
Requirement Specifications – User, Functional, and Infrastructure
Installation Qualification (IQ) approach to testing
Performance Qualification (PQ) approach to testing
Operational Qualification (OQ) approach to testing
Mitigation strategies – Disaster Recovery and Business Continuity
Risk Assessment – documenting system status as GXP or non-GXP
Saving time and money - the Master Plan approach
ABOUT THE COURSE:
The need to have computer systems operate as expected whenever they are in use is a common business concern across all work areas both regulated and non-regulated. In regulated work processes the need to document management control, system reliability, and data integrity becomes of utmost importance. This seminar day describes the common characteristics of global regulations related to computer systems and teaches a proven standards-based approach to meeting those regulations. It uses real project examples to illustrate a common sense approach to computer validation that has passed inspections and audits in North America and Europe.
Auditors and inspectors new to computer validation will see the process in its variations of OQ/IQ/PQ and examples of the types of expected documented evidence. Validation team members will see the “how to†process for their respective roles as OQ, IQ, or PQ teams. The use of a Master Plan and Forms process will be shown as a common sense approach to save time and money, yet maintain compliance for categories of systems and in-production control after go-live.
