The workshop has been designed to provide practical training and guidance to those responsible for the management and operation of a GCP-regulated archive or those who need to improve their knowledge and understanding about this topic. The programme defines what constitutes an archive and the specific regulatory requirements which apply to such facilities, highlighting any differences where they exist between different regulations. Delegates will understand how the principles described apply both to the management of traditional physical records (e.g. paper, tissues, biological samples) and to digital records. The workshop will be interactive, with delegates being encouraged to participate in discussions.
Consider Inspection Readiness:
• What does it mean? Does every employee understand his/her responsibility?
• Which activities can be done to ensure Inspection Readiness?
• Explore Standard Approach vs new concepts
• How do you implement lessons learned? Identify, analyze, and improve!
Gain Practical Insight with Two Activities:
• Inspection Readiness Day: Brief exercise for trial teams!
• Quality Compliance Assessment: Mimic internal audits with a clear focus!
• Define the major topics for inspection readiness
• Understand the meaning of inspection readiness for your daily work
• Design strategies to ensure inspection readiness for individuals, departments and the whole company
• Understand how to plan and conduct inspection readiness activities
• Enforce lasting improvements by effectively implanting lessons learned
• Discover the importance of “Do it right the first time”