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Mike Merges
Director of Biologics

Practical Solutions for GLP Studies of Biologics

Webinars
Course introduction

What challenges do you face in executing your Good Laboratory Practice (GLP) Studies? Good Laboratory Practices are critical to promoting the development of quality testing approaches and a sound scientific outcome. Every Study has unique characteristics whereby every decision must be carefully considered. You might face issues with documentation, deviations, standard operating procedures, training, test/control articles, roles & responsibilities or equipment requirements.

Management of all these difference makers is critical to the outcome of your GLP Study. Making the right choices along the way through careful planning is key to avoiding highly variable outcomes and instead leads to successful Study execution. In this webinar you will learn how to plan, execute, verify and report on GLP studies. All the topics listed above, and more, will be covered.

Join Mike Merges as he discusses how the understanding of key difference makers impacts the outcomes of GLP Studies. Register today to gain unique insights into practical solutions that can benefit your GLP program.


Presented by

Mike Merges is Director of Biologics at Catalent where he oversees Biologics, Viral Clearance, Microbiology and Biophysical Characterization. Mike has 30 years of experience in cGMP and GLP across in vivo and in vitro bioassays, immunological assays, viral neutralization assays, ELISA, and Flow Cytometry. He joined Catalent from Lonza where he was Associate Director of Bioservices. Prior to that, he was at the University of Maryland's Institute of Human Virology, the National Cancer Institute and Johns Hopkins University.



Learning objectives
  • Documentation& Training
  • Testing design and execution
  • Roles & Responsibilities
  • Equipment & Facility
Audience
  • Vice Presidents/Directors/Managers Analytical
  • Vice Presidents /Directors/ Managers of Research and Development
  • Vice Presidents/ Directors /Managers of Marketing/ Product Management
  • Vice Presidents/ Directors /Managers of Procurement
  • Vice Presidents/ Directors /Managers Director of Outsourcing/3rd party
  • Vice Presidents/ Directors /Managers Director of Corporate Development
  • Vice Presidents/ Directors /Managers Director of Commercial Operations
  • Chief Scientific Officers
  • Chief Executive Officers
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