Workshop

Post-conference workshop

Attacking the label bottleneck: tools and strategies for a best in class approach
Wednesday 27 February 2008, Rome, Italy

     

Led by: Ann McAlinden, Project Manager and James McAleavey, Label Control Manager, ALMAC

     
About the Workshop
 

A common issue for both large and small Pharma alike involves the label production process for IMP’s, their generation and approval. This traditionally can be a bottleneck that can affect trial start dates. Almac Clinical Services present a non-proprietary workshop that examines the nature of clinical trial labels, difficulties that arise and potential uses of technology to overcome these obstacles. Attendees can also learn about a Business Project Management approach to innovation and improving the clinical supply chain.

     
Agenda
9:30 Delegate registration and coffee  
10:00

The label generation process for IMPs

  • The critical design phase
  • Flexibility of supplies
  • Multilingual co-ordination
  • Lead times involved in the process
  • Current best practices

11.00

Using technology to improve the process – a business project perspective
  • Define the actual business problem
  • Challenges of specification and design
  • Setting judgement levels for an automated approach
  • Project deliverables and learning outcomes

12.00

Successful solutions to the IMP label bottleneck
  • Proof generation tools
  • Automated label inspection
  • On-line tools for label approvals
13:00  Close of workshop
     
About Your Workshop Leader
   
Ann McAlinden
Global Business Project Manager
Almac
Ann McAlinden is a Global Business Project Manager within Almac Clinical Services, with over 10 years experience in validation, quality and project management. Ann successfully led the team that developed and launched the industry’s first automated label verification system.
   
James McAleavey
Label Control Manager
Almac
James McAleavey is the Label Control Manager within Almac Clinical Services. James has overseen the introduction of automation within the labelling process and has many years experience of managing the label generation and printing function within Almac.
 


 

 

 

4th Annual Clinical Trial Supply USA