Training as a Diagnostic? The Hidden Gems of Determining Effectiveness


Instructor: Mike Kent
Product ID: 706339
Training Level: Basic to Advanced

  • Duration: 60 Min
This webinar will illustrate how to use training as a diagnostic tool for improving compliance and efficiency. Learn how to incorporate a few simple yet powerful strategies to help unlock new opportunities for risk reduction, process optimization and improved decision-making. Understand how to collect and then use training data to both advocate for and demonstrate impactful change.
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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.
Instructor Profile:
Mike Kent

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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Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).




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