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EPiC Top Tips – Assessing the Effectiveness of Training

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Measuring Success – Top Tips for Assessing the Effectiveness of Training

Article By Michelle Yeomans Operations Manager for EPiC Auditors

effectiveness of training

The Covid-19 pandemic led to changes in the amount and delivery method used by Pharmaceutical companies to conduct training. Some companies cut back on training to conserve resources for core functions, whilst others invested in virtual training and e-learning to provide continued development opportunities for their employees. The situation was no different for regulators.

During the pandemic, I was the Unit Manager of the GMP and GDP Inspectorate at the MHRA, and as well as developing remote inspection approaches to ensure a continued level of regulatory oversight, MHRA used the opportunity to dedicate Inspectorate resource to enhance the range of training materials available within the ‘Inspector Academy’ knowledge hub and developed virtual training modules and competency frameworks. At the time, it was a case of adapting to the situation and being innovative in exploring available tools and techniques to identify the “least worst” available option.

Post pandemic, several conferences and training events have now returned to being run as face-to-face events, while others are continuing to offer virtual or hybrid options to maximise accessibility and minimise costs. EU GMP Chapter 2, 2.11 refers to the need for “continuing training” to be given and for its “practical effectiveness” to be periodically assessed. Continuing training is an ongoing process of learning and acquiring new skills and knowledge to help individuals stay updated with the latest developments and changes relevant to their role and industry sector. Continuing training can include self-learning so is not just limited to attending workshops, seminars, conferences, or specialist courses. The key point is finding a way to stay current with industry trends, which will help increase expertise and proficiency and support compliance with GMP requirements. Another key consideration is the need to keep a record to document the training, as training records are routinely reviewed during a regulatory inspection and provide evidence of continuing professional development.

With different training opportunities and formats on offer, it is important to have clearly defined learning objectives and ways of collecting information to determine whether the training provided has produced the desired effect and contributed to the development of the trainee.

Here are our top tips for assessing the practical effectiveness of training:

  1. Pre and post-assessments: Conducting assessments, questionnaires, or quizzes before and after the training can help measure the knowledge, skills, or behaviour changes that have occurred as a result of the training. Comparing the scores or performance levels before and after the training provides an indication of the impact of the training.
  2. Observations and simulations: Observing participants during or after the training session can help assess their application of the newly acquired knowledge and skills. This can be done through simulations or real-world scenarios to evaluate their ability to transfer the learning into practical situations.
  3. Follow-up assessments: Conducting assessments weeks or months after the training has taken place can help evaluate the long-term impact and effectiveness of the training. This can provide insights into whether the learning has been retained, and if it has influenced the individual’s work performance over time.
  4. Feedback: Soliciting feedback from trainees and supervisors or managers who work closely with the individuals can provide an additional perspective on the effectiveness of the training. They can assess whether the training has positively impacted the individuals’ job performance, productivity, or overall contribution to the organisation.
  5. Performance metrics: Comparing PQS performance, KPIs or Quality metrics before and after the training can yield insights into any improvements or changes in the workplace performance of individuals or teams who participated in the training. An overview of GMP related training completed, and a review of PQS performance to identify compliance improvement topics for inclusion in further GMP refresher training should be included as agenda items at periodic Management Review meetings.

By using a combination of these assessment methods, organisations can gain a comprehensive understanding of the effectiveness of their training efforts and identify areas for improvement.

Please get in touch if you want to know more about our virtual symposia and bespoke in-house training courses.

Telephone: +44 (0)1244 980544 or email us at enquiries@epic-auditors.com 

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EPiC Top Tips-Knowledge Management

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Top Tips for Implementing Effective Knowledge Management Practices

Article By Michelle Yeomans Operations Manager for EPiC Auditors

Pharmaceutical Quality System

At the EPiC Autumn Compliance Seminar, I delivered a presentation outlining the direction of travel in demonstrating compliance  (Session 1. GMP Seminar 10th November 2022 9am to 10am) which highlighted how global regulators are looking at new ways to be agile and make best use of resources and reduce regulatory complexity.  

The aim is to benefit patients by supporting access to quality medicines by adopting the same requirements for the formats and data expectations in regulatory submissions and applying the same standards in regulatory review, assessment, and inspection to support reliance. Such approaches will require companies to demonstrate effective use of data, knowledge management and to implement a culture of continuous improvement throughout the product lifecycle.

How organisations create, manage, and use knowledge is a key component of an effective Pharmaceutical Quality System (PQS) as defined by ICH Q10. The need to minimise knowledge loss is a primary concern, as loss of knowledge can lead to poor risk-based decision making and inefficiencies in trying to retrieve past knowledge or having to  “reinvent the wheel” to replace lost knowledge.

Hardly a week goes by without seeing a post on LinkedIn from a network connection who is “happy to share” that they are starting a new position. Whilst this is exciting for the individual to be embarking on a new chapter in their career, what can organisations do to minimise the risk of specialist knowledge walking out of the door with them?

Tips for implementing effective knowledge management practices:

  1. It’s important to recognise that it is the people and not the data that underpin an organisations’ knowledge base. Compile and maintain a list or matrix of subject matter experts (SMEs) to increase awareness of “go to” people and encourage communication, networking and sharing of past and current knowledge.
  2. Don’t wait until someone is working their notice to try to capture all that they know, as there won’t be enough time to transfer valuable knowledge to colleagues. Think about how you can capture and manage knowledge as a continuous improvement activity e.g., capturing and implementing lessons learned and after-action reviews.
  3. Advances in technology to support remote collaborative working accelerated during the Covid-19 pandemic and has increased the availability and accessibility of creative tools to capture and share information. Explore what options are available with IT and Data Management colleagues to make use of available tools to help build and improve your knowledge management systems.
  4. Asking someone to write down everything they know about a particular product, process, system, operation is a daunting task. People may not be aware of the knowledge they possess or how valuable it is to others. Indecision on what to include could result in a lot of the implicit knowledge remaining in people’s heads and at risk of being lost. As implicit knowledge is often difficult to articulate, transfer of knowledge can be achieved more effectively by encouraging regular interaction with colleagues e.g., networking forums, and sharing practical experiences through coaching and mentoring opportunities.  
  5. For knowledge to be usable, it needs to be captured in an effective manner. Consider using a variety of formats to encourage information sharing and capturing knowledge e.g., video recordings, voice notes, whiteboards, story boards etc. Look at how the resulting output could be adopted into workflows, SOPs, Work Instructions, etc. as continuous improvement helping to retain current knowledge and support the development of new knowledge.

The above practical tips are intended to help minimise the risk of knowledge loss and support compliance with the EU GMP requirement to implement quality improvements appropriate to the current level of process and products knowledge (EU GMP Chapter 1, 1.4 (xi)) and ICH Q10 principles.

If you need our help and support, then please don’t hesitate to contact us.

Telephone: +44 (0)1244 980544 or email us at enquiries@epic-auditors.com