Practical Fundamentals for an Effective and Efficient On-the-Job Training Program

Why Should You Attend:

So how do you construct your Training system to assure the competency of people performing critical tasks in your GxP environment? How do you prevent unnecessary bureaucracy that can extend the time it takes to get someone doing what you need them to do? How do you ensure everyone gets trained to the same minimum level of proficiency so you can eliminate the need to always keep that one expert around to do the task? Most importantly, how do you ensure that key stakeholders remain aligned to the process and advocate for compliance, even during crunch time?

Regulated industries have been trying to move beyond the “box-checking” approach to training qualification for years. Yet FDA 483 observations and warning letters citing ineffective training are on the rise. Having a robust, efficient and effective OJT Program can move your company out of that risk zone, and into demonstrating better control over how someone becomes “qualified” beyond the signature on a training record.

We’ll discuss practical strategies for implementing an OJT program that improves both competency, consistency and efficiency, then give you the tools you need to make an immediate impact. We’ll also describe the steps you can take to ensure your program is scalable and remains sustainable as your organization grows.

Areas Covered in the Webinar:

• Regulatory agency expectations of OJT programs
• Program elements, administration and sustainability
• The Role Triad – the Trainee, the Trainer, The Managers
• Examples of OJT documentation – get a template that you can use right away!
• Learning Objectives and Performance Criteria – how they are different, and why both are important
• How to maintain consistency with qualification, disqualification and requalification
• Ideas for evaluating and documenting competency
• Handling prior experience effectively: the double-edged sword
• When OJT is required and when it isn’t
• How a strong OJT program can help eliminate deviations and make investigations easier

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, directors
• Clinical Development professionals – managers, supervisors, trainers
• Healthcare/medical professionals – managers, supervisors, trainers
• Production/Manufacturing managers, supervisors and trainers
• Laboratory managers, supervisors and trainers
• Safety/EHS training managers, associates/specialists and trainers

Free Materials:

• An example OJT document template
• One-time risk assessment of participant’s current OJT program

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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