Medical Device Meta-Management: Cultural Change in a Highly Regulated 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 Medical Devices companies have recently had trouble sustaining inventories in the field due to inconsistent quality, inventory control or simple non-compliance with their own systems; CAPA and inventory control being two key elements often noted in survey responses.  

The knee-jerk and, to be fair; accepted, reaction is to re-write or re-install the systems that were suspected to be the cause of the shortcomings.  Yet systems are not sentient; they do not manage themselves.  Systems are utilized by people and people are organized into teams and hierarchies.  How often do we examine the structure of the teams, the behaviors of the leaders and the management controls connecting the human to the process?

Academic references are provided for all tools, techniques and talking points.

The Course Will Cover in Detail

• Leadership organization and behavior
• Management Control Systems
• Effective change techniques in highly regulated industry

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.
• Define the inventory profile of their product: percentage of value in stock as components/raw material, in WIP or in the field.
• Define their CAPA volume profile; how many CAPAs are at each stage of the CAPA process and how many CAPAs are completed every month.
• Review a CAPA or inventory 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 and inventory control systems
• How to diagnose a struggling CAPA system
• Several effective techniques to aid in accurate root cause analysis
• How to ensure CAPA actions are implemented effectively
• How to measure the CAPA system's effect
• How to identify bottlenecks in the process
• How to quickly determine cycle times using inventory values

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.