Revolutionising the Lean Enterprise: Leadership, Cultural Change and Techniques for Today's Pharma Industry

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Course Overview

It is said that continuous improvement is a journey; a journey with a stated, yet unattainable destination.  If the analogy is exploited it is easy to agree that management teams need a vehicle to convey them on their journey.  All vehicles have three things in common; a source of energy or power, a controller/pilot/driver and a system of controls to connect the motor with the driver.  Without one of these elements it is fair to predict that progress towards the destination, or continuation of the journey in an effective manner would be erratic, if not downright dangerous.

Several BioPharma companies have recently received warning letters from their regulators for consistently contaminated product, poor systems or simple non-compliance with their own systems; CAPA and validation systems being two key elements often noted in punitive documentation.   The knee-jerk and, to be fair - accepted, response is to re-write or re-install the systems that were noted to be out of compliance.  Yet a system is not sentient; it does not apply itself.  Systems are utilized by people and people are organized into teams and hierarchies.  How often do we examine the hierarchies, the behaviors of the leaders and the management controls connecting the human to the process?

Academic references are provided for each tool, technique or talking point.

The Course Will Cover in Detail

• Leadership organization and behavior
• Management Control Systems
• Effective change techniques in BioPharma

This interactive, simulation-centered course lays out the fundamental framework for coherent and holistic review of the three facets of continuous improvement, AKA cultural change.

Who Is It For?

Vice Presidents, Senior Directors, Directors, Site Leaders, Operations Executives and Quality Representatives, senior industry regulators, Manufacturing Directors, Operational Excellence Directors, Human Resources practitioners and Lean Deployment Champions.

Workshop Preparation

• Sketch out the operational hierarchy of their site/s or domain, including quality, manufacturing, finance and human resources.
• Draw up a list of performance indicators in daily use in their teams
• Observe meeting behaviors closely, focusing especially on actions decided upon and follow up
• Review a CAPA or a validation issue and list team members involved, indicators used, tools used and actions taken

What Can I Do After Participating?

• Understanding the true multi-faceted nature of cultural change in a regulated environment
• The ability to model an effective and holistic improvement model for their domains
• The knowledge of how best to depict, and therefore effectively analyze and adjust, quality systems
• How to identify true root cause in all three key facets of operation; leadership, systems and techniques
• How to use several root cause analysis techniques appropriately
• How to analyze and diagnose organizational structures and determine their impact on cultural change
• How to remedy faulty management control systems
• The ability to determine when to use visual controls vs. formal management control systems

What Course Materials are Provided?

Each participant will receive a welcome pack with a comprehensive set of documentation including all of the course notes, handouts, presentation material and applicable reference material on a USB stick, and all other supporting documents in printed format.