cdsIt’s really hard to keep everyone happy when it comes to training – it’s usually a balancing act between achieving high quality training and the need to get operators running analyses quickly. If you speed through the training in a manner that the user doesn’t gain the correct knowledge, you risk mistakes, but the laboratory needs its staff to be productive as quickly as possible.

When you consider how you perform effective training for something as important and multifaceted as Chromeleon CDS, then you need to balance speed and quality alongside the constant challenge of the different levels of experience and confidence that new operators have in this type of software. So in this blog post I will describe how we “walk the training tightrope” to deliver our training effectively depending on job role and previous experience alongside some of my personal top tips for a performing a successful CDS training session.

User Roles

For our training to work effectively we have set up Chromeleon CDS and our Administration Console with multiple user roles to differentiate access to our various Data Vaults (DV), which ensures we remain compliant.

We have several user roles:

  • Training – when a new starter arrives they can use this account. It only allows them access to the Training and Development DVs where no GMP work is carried out.
  • Analyst – access to the Development and GMP Production DVs. Access to the Training DV is removed.
  • Chemist – has read only access which allows the user to see data relating to their tests.
  • Super User – ability to create new users, change passwords, create eWorkflow™ procedures and protect report sheets.
  • OQ – review only access giving the user only the ability to review work, not change anything.
  • CDS Admin – ability to administer the software. No analysis can be run with this role.

User Categorization

We assign our new operators to one of the three categories detailed below. In order to do this, we have to understand their previous CDS experience, which allows us to group them with similar level users, ensuring we can deliver the training appropriately.

  • None – No previous CDS software experience. These users can be easier to train as they have no preconceptions and they are not ”un-learning” another CDS software but they may need more training than an experienced CDS user.
  • Experience of other CDS software – often this takes a while as it requires ‘un-learning’ processes to be able to use Chromeleon CDS to its full capabilities.
  • Experience of Chromeleon CDS software – This is the quickest as it is fairly straightforward and normally involves just learning the differences between their version and ours (if there are any) and showing them the way we do things.

We also perform a quick “benchmark” test before training (simply asking the operator to zoom in on a peak) which allows us to understand how well someone will take to Chromeleon CDS. Zooming in should be something that comes fairly naturally to an analyst and how they handle this can highlight how quickly they can learn the software.

No matter what an analyst’s background, you can pretty much guarantee that for the first hour or so they look like a “rabbit in headlights.” The point at which they lose this look and the light bulb goes on typically depends on their background; users with no experience usually take 2 – 3 hours, those who are used to different CDS software take between 1 – 2 hours (it seems to ”click” once they can find the equivalent things in Chromeleon CDS) and former Chromeleon CDS users normally click after the first hour if they have used a different version.

Training Stages

Each of the six roles has a set training structure to ensure that the user is able to confidently and accurately perform in the lab. The time spent on each topic is determined by the user category and the training is pretty quick no matter what the user’s experience level is because Chromeleon CDS is very intuitive. It means you usually get trainees learning their way around the basics of the software in a couple of sessions. New starters often say they like the categories and ribbons in the Chromatography Studio as it helps them associate an icon or category with a specific task.

We will look at the analyst training as an example, the typical schedule is shown in Table 1.

Session

Topic

Duration

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No experience Used another CDS software Experience of Chromeleon CDS
1

Naming Conventions and Look Around

Creating Sequences

2 hrs 1.5 hrs 1 hr
2

Creating Sequences

Integration Practical

2 hrs 2 hrs 2 hrs
3

Audit Trail/Data Review

Questions and Answers

2 hrs 1.5 hrs 1 hr

Table 1: Typical analyst training schedule

The three sessions cover:

  1. How we name everything in Chromeleon CDS with a thorough overview of the software and a sequence layout practical. We cover both HPLC and GC headspace sequences, as HPLC is the most common but headspace is the most involved.
  2. The integration practical uses real data to show how the Cobra wizard works and how to integrate in a consistent, scientifically sound and accurate manner. This also covers when, why and how we use manual integration.
  3. The audit trail/data review session covers how to view the various audit trails and what to look for when reviewing data (in general) or audit trails. We ensure the trainee recognizes what auditors look for and how to describe what they have done, simplifying data review and avoiding forensic reviews by auditors.

An optional extension (called continuous improvement) is available to selected analysts giving them eWorkflow training and report template development skills. This may not happen for some time after the initial training and depends on the user’s confidence with the software.

Compliant Training

In order to maintain compliance, we ensure that every piece of Chromeleon CDS training is documented using Knowledge Based Assessments (KBA) which are predominately a test of a person’s understanding of the SOP/software and Skill Based Assessments (SBA), which are practical training sessions. These not only help the analysts become more comfortable with the software but also help keep the trainer on track ensuring every person is trained in the same things. The analyst also gets a specific folder in our Training DV where all of the practical works goes and we use electronic signatures, once the session is completed, to have the trainee sign the sequences/practical to confirm they understood the training. This means that we have both training documents and software-based records of the training which are retained, in their entirety, forever.

Progression to Super User or CDS Admin roles is controlled by the management team and is limited to users showing aptitude in the CDS, with a desire to learn more and accept more responsibility. This ensures we only give those extra responsibilities to those who can handle it, which is something auditors want to see.

My Training Top Tips

Some of these may be obvious, however, since I started training I have taken these few things to heart and stuck by them:

  • Allow the trainee to settle into the company for short time before training. It allows them to get used to the company and have a hands-off look at Chromeleon CDS.
  • Plan to run the training sessions over the space of two weeks. This allows for lots of questions, hands-on experience and recaps to the previous sessions with time to ensure users really understood the training.
  • Never train for more than two hours at a time – attention drops significantly after this.
  • Never assume anything! Just because they may have used Chromeleon CDS before it doesn’t mean they are comfortable with your version. They may need to use it more or less than they are used to.
  • Get hands-on! Do as many practical sessions as possible.
  • Limit training to two trainees per trainer to ensure each person gets the same level of training and make sure they are of similar experience.
  • If your language isn’t the trainee’s first language, be ready with lots of different ways to explain things and ensure they understand before moving on. Never rush the training. Take the time to stop and go through again; slower with greater understanding is far better than fast with poor understanding.

I will admit, I never thought I would be a trainer let alone writing a blog post on it, but you know it turns out that I actually enjoy it! You get a feeling of pride when you train someone and then audit them two months later to find they have done everything right. Of course I am always conscious that we can continue to improve our training, so I always solicit feedback from every training, which we use to not only improve the training resources but also ourselves as trainers. This means our training process is constantly evolving as we update our procedures and develop our skills.

So, this is our training process to quickly bring our analysts up to a proficient standard and ensure they work accurately, consistently and compliantly when using Chromeleon CDS, meeting our business and regulatory needs. I hope it has given you some food for thought and might help when you need to walk the training tightrope.