Article 7.4 of EU Directive 2003/94, which lays down the principles and guidelines of GMP, requires that: ‘The personnel shall receive initial and ongoing training, the effectiveness of which shall be verified,…’
When it comes to designing and delivering GMP training, we take into full consideration that –
- The depth and length of modules are customised to suit the specific audience and experience levels
- All modules are delivered in a structured format of instructor-led content, teamwork and quiz
- Knowledge points are elaborated with real case studies and examples that the trainees can easily relate to
- The latest technologies and tools (e.g. Klaxoon) are used to make the classroom interactive and fun – even remotely, and most importantly
- We always explain WHY: when the rationale behind requirements is explained, it brings meaning to those words and sentences, it makes the GMP requirements logical and hence so much easier to understand and memorise.
It is critical for everyone working in the pharmaceutical industry to understand fundamentally the significance of GMP, to place the patients at the centre and to take pride in what we do. It is our ultimate goal to supply products with Quality, Safety and Efficacy to the ones we care about.
To develop further, it is equally important to explain that the intention of GMP requirements is to ‘assure’ quality rather than to ‘test’ it.
Teamwork helps the trainee to better transfer knowledge into practice. It also strengthens collaboration and communication among members. Giving an example of the Quality System module, once the basis of PQS elements is explained, the team is provided with various real-life scenarios and asked to apply the PQS elements. In this way, they gain a clearer picture of the purpose of, and the relationship between each element.
Some other techniques of delivering interactive and effective training could be starting the module with a series of questions that encourages the trainee to develop a train of thought around the key messages and sequence the module content in a (logical) process flow manner.
In between modules and at the end of the training, a quiz will be conducted to revisit the key points. Scoring is not the objective of the quiz; reviewing answers with the team is a more effective means of capturing knowledge. Again, thanks to the new tools available, the quiz can be carried out in a fun way.
There might be different forms or modules we deliver under the GMP training series, however, the common objective of them all is to help the trainees not to just ‘do GMP’ but to ‘think GMP’.
You can read our article on how to reach a quality mindset in the pharma industry which mentions such a mind-shift change towards proactive orientation.
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At No deviation, we also partner with you to help you build the quality in your product. Reach out to us to know how we can help you achieve, retain, and regain cGMP compliance.
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With 15 years of experience in the global pharmaceutical industry, predominantly in Process, CQV, Process Automation and Project Management, Shanshan has held both Consultant and End User roles. With increasing involvement in the GMP remediation and GMP audit projects, she has been building in-depth compliance knowledge as well as interaction with authorities globally.
