Remind Me Again Why We Need Compliance Refreshers

For many organizations, the sole purpose of refresher training is to satisfy compliance requirements. Hence, the focus is on just delivering the content.  Ironically, the intent behind the 211.25 regulation is to ensure that employees receive training more than at orientation and frequently enough to remain current.  The goal is to ensure compliance with GMPs and SOPs and improve performance where there are gaps.  Improved business performance is the result and not just a checkmark for 100% attended. 

And the practice of repeating the same video year after year as the annual refresher? Efficient yes, effective, well just look at your deviations and CAPA data to answer that one.  When you shift your focus from delivering content only as the objective to a more learner-centered design, your sessions become more performance-oriented and your effectiveness reaches beyond just passing the GMP Quiz.

From passive lecture GxP refreshers to active learner centered sessions

Yet, senior leaders are not grasping that just “telling them the GMPs” is not an effective training technique, nor is it engaging.  Even if it’s backed up with a slide deck, it’s either “death by PowerPoint” or click to advance to the next slide for CBT refresher modules.   Koreen Pagano, in her June 2014 T&D article, “the missing piece”, describes it as “telling employees how to swim, then sending them out to sink, hoping they somehow can use the information we’ve provided to them to make it shore”, (p.42).  To make matters worse, employees can end up with disciplinary letters for deviations and CAPAs for failure to follow GMPs.

Look at the GXP Refresher course outline for the last 3 years at your company. What is the ratio of content to interactivity? When I dig a little deeper, I usually discover a lack of instructional design skills, and minimal creativity is a factor.  And then I hear, “Oh but we have so little time and all this content to cover, there’s no more room. If I had more time, you know, I’d add it in.”  Koreen informs us that “training is supposed to prepare employees to be better, and yet training professionals often stop after providing content” (p.43).

See What’s so special about SMEs as Course Designers?

What about using previously developed compliance materials?

I am not criticizing the use of previous course materials if they were effective.  But asking an SME to “deliver training” using a previously created PowerPoint presentation does not guarantee effective delivery. Neither does replacing clip art with new images or updating the slide deck to incorporate the new company template.   These visual “updates” are not going to change the effectiveness of the course unless the content was revised, and activities were improved. 

For many SMEs and Trainers, having a previous slide deck is both a gift and a curse.  While they are not starting with a blank storyboard, there is a tendency to use as-is and try to embellish it with speaker notes because the original producer of the slide was not in the habit of entering his/her speaking points for someone else to deliver.  Speaker notes embedded at the bottom of the notes pages within PowerPoint slides is not a leader’s guide.  While handy for scripting what to say for the above slide, it does not provide ample space for managing other aspects of the course such as visual cues, tips for “trainer only” and managing handouts, etc. 

The SME has the burden to make content decisions such as what content is critical; what content can be cut if time runs out.  Perhaps even more crucial is how to adapt content and activities to different learner groups or off-shift needs. Without a leader’s guide, the SME is unsupported and will fall back on the lecture to fill in the duration of the course. 

“SMEs put down those speaker’s notes and step away from the podium!” Vivian Bringslimark, HPIS Consulting, Inc.

Better Training Means an Investment in Instructional Design Skills

Interactive, immersive, engaging are great attributes that describe active training programs.  But it comes at a price: an investment in instructional design skills.  Trained course designers have spent time and budget to create an instructional design that aligns with business needs and has measurable performance outcomes. The course materials “package” is complete when a leader’s guide is also created that spells out the design rationale and vision for delivery, especially when someone else will be delivering the course such as SMEs in the classroom.

The Leaders Guide, invaluable for effective course delivery

A well-designed leader’s guide has the key objectives identified and the essential learning points to cover. These learning points are appropriately sequenced with developed discussion questions to be used with activities; thus, removing the need for the Trainer/SME to think on demand while facilitating the activity.  This also reduces the temptation to skip over the exercise/activity if s/he is nervous or not confident with interactive activities such as virtual break out groups, etc.

A really good guide will also include how to segue to the next slide and manage seamless transitions to next topic sections.  Most helpful, are additional notes about what content MUST be covered, tips about expected responses for activities and clock time duration comments for keeping to the classroom schedule.  SMEs as Facilitators (Instructor Led SMEs| ILT SMEs) need to study the leader’s guide and pay attention to the icons and notes provided there. These cues indicate the differentiation from lecture, to an activity whether that be self, small group, or large group.

Given all the time and effort to produce the leader’s guide, it is wasted if the course designer and SME as Facilitator do not have a knowledge transfer session.  Emailing the guide or downloading it from a share point site will not help the SME in following the guide during delivery unless an exchange occurs in which SMEs can begin to markup their copy.  

Resource from SME as Facilitators Workshop

During the knowledge transfer session/ discussion with the course designer, ILT SMEs make notes of how the instructor transitions from one slide to the next and how s/he provided instruction for the activity. This is a good time for ILT SMEs to ask how to modify content or an activity if certain conditions should occur. Especially important for SMEs to ask is what content is critical and what content can be skipped if time runs short. It is always a good idea for the ILT SME to mark-up his/her copy of the materials. And then again after the first delivery to really make it their own leader’s guide.  For example, SMEs may want to experiment with different ways to “open a session” to get experience with a variety of techniques and observe which ones yield better results.

Why do ILT SMEs need their own Qualified Trainers workshop?

  • When GMP courses are designed with the learner’s needs in mind, including adequate duration for exercises and activities, learners begin to engage with the content through the skill of a qualified facilitator who can guide the experiential activities.
  • When learner-generated responses are immediately incorporated into the session and leveraged to enhance the debriefings, the involvement and future application back on the job is even greater.

In order to pull this off, ILT SMEs need to learn how to facilitate learning experiences such as preparing to have a facilitated discussion.  One of the biggest fears ILT SMEs have when asked to facilitate an exercise or an interactive activity is the fear of it bombing such as discussions. 

Discussions can often bomb

While popular and commonly used, discussions can also fail miserably if not designed well. Relying on the SME to facilitate the discussion without carefully preparing the path to the targeted outcome is leaving it to chance that the SME knows how to execute the activity successfully. It includes the upfront questions to ask, pertinent examples as reference, and application type activities in which clarifying comments can be addressed.

 “It takes effort to get out of your head and connect with individuals.” Ludwig, D. Training Industry, Fall, 2015, p. 23.

“… So as to remain current in the practices they perform …”

Is once a year GXP refresher enough? Before you rush to answer this question, consider the following.  Do you have:

  • a lot of human or operator error related deviations?
  • or regulatory observations that include failure to thoroughly investigate …?
  • or a large percentage of repeat deviations?

Then you might be sending the mixed message that your employees are NOT trained well enough or sufficient in their knowledge and application of the GXPs.

Twice a year has fast become the new norm.

There’s a difference between GXP training content that is delivered as a repeat of the same materials vs. new and/or updated. Yes, new content takes resources and time. But, how many times do you want to sit through the same old slides and get nothing new from it? Recall the definition of insanity – doing more of the same while hoping for change. – VB

References:

  • Ludwig, D. “Lets Get Serious about Live Instructor-led Training”, training industry, Fall, 2015, p. 23.
  • Pagano, K. “The Missing Piece”, T & D, June 2014, pp. 41 – 45.
  • Rock, D. “Your Brain on Learning”, CLO, May 2015, pp. 30 – 33,48.
  • Silberman, M. (1990). Active Training: A Handbook of Techniques, Designs, Case Examples, and Tips.  Lexington Books, New York.

What’s so special about SMEs as Course Designers?

They have expertise and experience and are expected to share it via training their peers.  But now the venue is the classroom as well.  It’s training on course design methodology that is needed. SMEs and most trainers do not automatically have this knowledge.  Some develop it by reading A LOT, attending well-designed courses, and over time with trial and error and painful feedback.  The faster way is to provide funds to get SMEs as Course Designers at least exposed to how to effectively design for learning experiences so that they can influence the outcome of the objectives. 

This is management support for SMEs as Trainers.   SMEs who attend an ID basics course learn how to use design checklists for previously developed materials.   These checklists allow them to confidently assess the quality of the materials and justify what needs to be removed, revised or added; thus, truly upgrading previously developed materials.

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