Industry professionals David Lerner & Justin Iovino, senior members of the MES-SIG, review the guide and discuss how it can be used to successfully plan, design and manage a multiple-system manufacturing environment to address key challenges in life sciences manufacturing companies. Learn how the key concepts and best practices defined in the guide can be used to effectively manage integrated MES programs. At the conclusion of this session, participants will be able to:
- Creating and managing a compliant, integrated manufacturing environment.
- Structured approach to plan, develop and implement a program for MES within the enterprise, including business drivers, organizational considerations and Risk Management.
- Implementing a methodology for creating and using Electronic Production Records (EPR).
- Identifying, defining and documenting best practices from around the world for implementing MES in regulated environments.
- Best practices in performing analysis of understanding your company before you begin to purchase.
David Lerner is a Managing Consultant within the Life Sciences Practice of PA Consulting Group specializing in manufacturing, regulatory, quality assurance processes, system implementation and validation projects. His involvement in MES has extended over thirteen years and spans industry, software vendor and consulting perspectives of the MES Domain. While at McNeil Consumer and Specialty Products Company, he led the design, development, deployment of a custom EBR system. He also worked for an MES vendor as a project leader on MES implementation projects. Lerner regularly performs assessments of MES systems advising clients on strategy, scope, benefits, issues and risks. Lerner holds an MBA from University of Texas at Austin and a BS in mechanical engineering from Lehigh University.