Training as a Diagnostic? The Hidden Gems of Determining Effectiveness

Why Should You Attend:

FDA 483 observations and warning letters citing ineffective training are on the rise. Over the last decade, regulatory agencies have increased their expectations around companies having a mechanism in place to determine the effectiveness of training. What if you also used those mechanisms to diagnose what’s really going on, enabling actions to focus on true root causes and have a larger impact? What if the data you generate from feedback, both during and after the training, could be used to support recommendations on how best to mitigate those risks? And how do you accomplish all of this with limited resources and competing priorities?

Ongoing training is both a requirement and an opportunity to reinforce compliance expectations. So how do you demonstrate the effectiveness of all that training? Capturing feedback and on-the-job training metrics only take you so far. Data that shows where the performance and compliance gaps are can be a powerful tool in not only mitigating risk, but also in help to demonstrate the larger value of training.

We’ll discuss practical strategies you can use for gathering data out of training, and how to use it diagnose and prevent compliance risks from becoming compliance gaps. We’ll help you develop a plan to get started, then give you the tools you need to sustain your new approach.

Areas Covered in the Webinar:

• Regulatory expectations for determining effectiveness of training
• Benefits to a multi-faceted view of training effectiveness
• What data is – and is not – critical to improving effectiveness
• Using feedback surveys to diagnose localized and systemic risk factors
• Isolating the impact of training vs. other performance improvement factors
• Translating diagnostic data into actionable steps to improve performance
• Overcoming challenges due to limited resources
• Using data to secure unwavering management support for training

Who Will Benefit:

• Training professionals in regulated industries (pharma, medical device, biologics, diagnostics, food, dietary supplements, healthcare/medical) – trainers, associates/specialists, managers, directors
• Quality Assurance professionals – associates/specialists, managers
• Clinical Development professionals – managers, supervisors, trainers
• Healthcare/medical professionals – managers, supervisors, trainers
• Production/Manufacturing trainers and supervisors
• Laboratory managers, supervisors and trainers
• Safety/EHS training managers, associates/specialists and trainers

From the following Industries:

• Pharma, medical device, biologics, diagnostics, food, dietary supplements, healthcare/medical. Research, clinical and commercial scope.

Mike Kent
Principal Consultant, Kent Quality Performance Group

As an independent consultant, Mike Kent helps solve performance challenges around both systems and people, enabling organizations to gain an edge along their research, development and commercial paths. He has over 28 years of quality and technical expertise in regulated environments across the pharmaceutical, medical device, biologics and diagnostic industries. Mike helps create and sustain a robust quality culture focused on good decision-making and engagement. A drug development chemist turned quality systems professional, he enjoys optimizing the interface between people and their work environments. Mike lives in Littleton, Colorado, with his son, and is a professional voice actor as the other half of his business, Kent Quality Performance Group. He spends his free time hiking, cycling, running and creating music and photographic art.

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