BACKGROUND
1, 2 and 3 day training programmes for IT professionals, business users, business quality
Quality “culture” low in maturity
Quality viewed as a constraint to creative thinking
OBJECTIVES
- Establish an understanding of “Risk Based” validation
- Clear fog of quality myths and legends
- Introduce scaleable approach
- Develop understanding of relationships between Good IT Practice and Validation
APPROACH
- Seek feedback on expectations and concerns prior to training
- Included interactive workshop for each topic
- Developed understanding of Good IT Practice controls prior to introducing CSV concepts
- Related all topics to patient, regulatory and business risk
- Provided examples of scalable approach throughout
OUTCOMES
- Attendees no longer feel constrained and offer improvement ideas for current CSV processes
- Greater upfront planning of CSV activities
- CSV integrated into overall project activities
- Validation deliverables add value to organisation
CHALLENGES
- Gaining appreciation business vs. IT accountability
- Organisation management recognising the cultural changes required to move forward
BENEFITS
- Validation costs significantly reduced
- Documentation is maintained as it adds value to the services provided by IT
- Business roles vs. IT roles more clearly defined and owned by rightful owners
EXAMPLE 2 DAY PROGRAMME
| 09:00-09:30 | Intro and determination of what the delegates want/expect |
| 09:30-10:00 | Laws, Regulations and Business Drivers for CSV |
| 10:00-10:45 | GAMP 5 ® An Industry Approach to CSV |
| 10:45-11:00 | BREAK |
| 11:00-11:45 | Risk Management |
| 11:45-12:30 | WS: Risk Management |
| 12:30-13:15 | LUNCH |
| 13:15-14:00 | Effective User Requirements |
| 14:00-14:45 | WS: Infrastructure Qualification |
| 14:45-15:00 | BREAK |
| 15:00-15:45 | Infrastructure Qualification |
| 15:45-16:30 | Supplier Assessment |
| 16:30-17:15 | WS: Supplier Assessment |
| 08:30-09:15 | E-records and signatures |
| 09:15-10:00 | WS: Outline a Validation Strategy |
| 10:00-10:30 | Validation Planning |
| 10:30-10:45 | BREAK |
| 10:45-11:15 | Specifications, Design Review and Traceability |
| 11:15-12:00 | Protocols and Testing |
| 12:00-12:45 | WS: Planning testing |
| 12:45-13:30 | LUNCH |
| 13:30-14:15 | Change Management |
| 14:15-15:00 | WS: Change Management |
| 15:00-15:30 | Validation Reporting and Presentation to Inspectors |
| 15:30-15:45 | BREAK |
| 15:45-16:15 | Data Migration |
| 16:15-17:00 | Maintaining Control in Operation |
| 17:00-17:15 | Wrap Up |