Ed Boyer

Senior Pharmaceutical Manufacturing Consultant, Brock Solutions

Ed has over 30 years of experience in pharmaceutical manufacturing working in technical support, quality assurance, laboratory operations, project management, and regulatory compliance. In his most recent position, he managed a regulatory compliance project in a large pharmaceutical manufacturing operation over 3 ½ years to update validation documentation and related practices to contemporary standards.

Projects within an organization usually require employees to adapt to a new process or environment. Projects that are driven by costs reductions, acquisitions, divestitures, or regulatory compliance are likely unpopular with current employees. Special attention, beyond traditional engineering project management techniques, is needed to change negative behaviors and culture for long-term success.

This presentation will describe a proactive approach to managing this aspect of a project and a set of tools that should be used by project leaders and supported by management. Where these tools are used effectively, the culture change required from existing employees will be more successful, lifecycle costs will be reduced, and the change will be sustainable.