Agenda

Life sciences companies are trying to cope with the mounting challenges of managing and maintaining quality systems while facing increased compliance risks. Clinical trials are becoming more complex and the Food and Drug Administration (FDA) is scrutinizing data to a higher degree. This is leading to increased demands on quality organizations, and many are drowning in a paper-based systems while struggling to maintain compliance.

As a result, life sciences organizations are looking to invest in quality management solutions (QMS) earlier in their life cycle. This workshop will address key questions about QMS including:

  •   When is the right time to invest in a quality management solution?
  •   What are the triggers?
  •   The benefits of QMS for an emerging firm.
  •   Integrating your QMS with other enterprise applications.
  •   What kind of business values do firms get?

A panel of industry professionals will then share, through a facilitated discussion, their experiences with deploying and realizing the benefits of QMS. They will discuss best practices they have implemented and lessons they have learned.

Panelists:  

Alkermes, Inc.
Jinna Penachio, Manager, Quality Information Systems
Rob Rimmer, Project Manager, Quality Information Systems

MannKind Corporation
Dina Maines, Director of Quality Assurance

Shire HGT
Roland Smith, Manager, Quality Technical Systems

Maxiom Group
John Lyons, Vice President, Solutions Practice

Sparta Systems, Inc.
Mike Jovanis, Vice President, Product Management