Thursday, 8 November 2018
9:00
Welcome & Attendees Introduction
9:00
Technology Transfer – Definition and Main Principles
- Opportunities along product lifecycle
- Regulatory guidance on technology transfer
- Planning and Social Intelligence
- Tool for planning
10:00
Technology Transfer – Definition and Main Principles (continued)
- Tool for Social Intelligence
- Role and responsibility
- General org chart in technology transfer
11:00
Coffee Break
11:30
Technology Transfer Project Management Tools
- Timelines
- Leadership
- Communication
12:30
Lunch Break
13:30
Technology Transfer Documentation
- Technology Transfer Plan
- Technology Transfer Report
- Feasibility batches Protocol and Report
14:30
Technology Transfer Procedures
15:30
Coffee Break
16:30
Analytical Transfer
- General approach (transfer vs validation)
- Analytical Master Plan
17:00
Recap of the Day
17:30
End of Day 1
Friday, 9 November 2018
9:00
Recap of the Main Concepts of Day 1
09:30
Introduction into Technical Report TR 65
- Project staging
- Risks in technology transfer
- Risk Management in technology transfer
10:30
Introduction into Technical Report TR 65 (continued)
- Severity/Occurrence/Detection in technology transfer
- FMEA
11:00
Coffee Break
11:30
TR 65 – Case Study 1 'Analytical Method Transfer (AMT)'
- Design of Comparative AMT Test Studies
- Selecting AMT Performance Characteristics
- AMT Documents
11:45
Step 7: Verify Corrective/Preventive Actions
- Implement & measure corrective/preventive actions
- Evaluate control plan
- Determine additional preventive actions
12:30
Lunch Break
13:30
TR 65 – Case Study 2 'Manufacturing Process Transfer'
- Overvew of Manufacturing Process Transfer
- Development to Commercialization Technology Transfer Process
- Intracompany Technology Transfer Process
16:30
End of Course