11.17.2020 Timothy Reinhardt

    Checking the box is no longer enough for training management

    Shifts in the landscape of quality management training

    When I started in the pharmaceutical industry nearly thirty years ago, training meant collecting large numbers of various staff members into a conference room on a slow day and methodically walking through a high-level general presentation packed with incidental information. This exercise was repeated annually for my first three years, with what seemed to me to only contain tiny alterations to the training material. Proficiency, engagement, and creativity were not a driving factor in the sessions. It seemed more about filling an afternoon and checking a box. Today, with the nature of the remote working environment, there is a need to be creative in delivering training that will effectively educate staff on critical elements. Filling a conference room is no longer an option, especially with today's distributed teams. Not only has the logistics of training changed, but so have the expectations. The FDA Guidance on Quality Systems, issued in 2006, stated, "Under a quality system, continued training is critical to ensure that the employees remain proficient in their operational functions and in their understanding of CGMP regulations."

    This commentary contains two crucial elements:
    1. Employees should be proficient, which means companies must have documented evidence illustrating this proficiency.
    2. The guidance links proficiencies to the operational functions. To satisfy this goal, a company must identify the function of the audience receiving the training.

    How can you leverage technology to specialize and maximize your training?

    Fortunately, technological advances have allowed companies to construct training that will deliver effective information to specific staff. To adapt, companies can use the internet, video, and various software to provide training sessions. One key benefit is that these sessions do not need to be delivered simultaneously. Interactive material can be stored in a location, allowing employees to access wherever and whenever they would like.

    For live training, you can quickly set up sessions with a large volume of people, allowing you to tap into resources with less constraints around logistics. This can be extremely helpful when you would like to link in subject matter experts into a session. Technology has also improved a company's ability to provide precise training to retain staff's attention by keeping information relevant. Videos can be made of a specific site or department requirements and technology. Regulations can be illustrated in the exact environment where staff work; for example, laboratory personnel can be trained on lab investigations or OOSs, or warehouse personnel can be training on Good Distribution Practices.

    This does not preclude a company's ability also to provide general core training. Instead, it offers the ability to adapt training to the audience. An example, for a small virtual company, a core general review of regulations can be a core for all employees. Simultaneously, specific training on GMPs for Phase 1 can be aimed at people in the CMC area, while ICHE6 can be aimed at the clinical space staff. Core training can be dispersed to staff to review before a live interactive online training.

    This will make the live session more fruitful, so basic concepts do not need to be covered for more experienced staff. Technology not only helps with material availability but can also assist in constructing training material. A person assigned to create training has endless access to information available on the net. Next, live videos can be made by anyone with a cell phone. This tool allows staff to have extensive training or a simple visual reminder.

    From videotaping to free editing tools, it is easier than ever to create interesting and engaging sessions. Software allows companies to splice together material and imbed questions into session to assure proficiency with the material.

    What to look for when outsourcing training

    If you decide to purchase training, technologies have provided companies with various options. Online streaming training scheduled individually and directly allows you to bring expertise to your organization. This option can be more expensive and will require you to coordinate all staff scheduling.

    You must also assure the subject matter expert providing training is a suitable match for your targeted staff. There is general recorded material or webinars available, but this normally high-level may not be suited for your audience. Some of these sessions do not allow for questions and answers, so your staff may not be able to interact with the subject matter expert. Since these are not custom, it must be assured that the material is well suited for your company's size, technology, and processes.

    A better option for interactive training in a remote environment is recorded training video rentals or purchases with a built-in live online Q&A session. This allows for a wider audience to receive core training, especially if the material is offered with unlimited number of people to access the material at any time, which is convenient for the individual team members.

    A live online follow-up with the same trainer to explore topics in a more in-depth approach then creates a robust training presentation. Questions and answer sessions facilitate free-flowing interaction between the trainer and trainee(s) until the questions are answered to the trainee's satisfaction.

    However you decide to structure your remote training, it’s clear that checking the box is no longer enough when it comes to training management.


    Do you want to learn more about maximizing your remote training?  Join us on  November 19th from 12:00-12:45 for "Training Beyond Standard Operating Procedures," an interactive forum, including best practices for training remotely for Life Science companies.

     About Timothy Reinhardt
    Timothy Reinhardt has worked in the pharmaceutical industry since 1992, including 18 years of quality leadership at Pfizer Inc, with the most recent role as the Director of Manufacturing and Supplier Quality Assessment. Tim was also the former leader of the Pfizer Site Auditor Training certification program as well as a member of the global data integrity assessment team. Tim will be serving RMC clients as both a Senior Consultant and Site Manager for the RMC North Carolina operations in the Raleigh area.


    Published by Timothy Reinhardt November 17, 2020
    Timothy Reinhardt