Training -Think outside the box
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Training -Think outside the box

When it comes to training, I have found that the reactions that one gets are common across different types of regulated industry. The reactions are based on the level at which one works in an organisation, namely,

"It is going to eat into my time of actually doing my job."- Execution level

"I need to make sure the training records are up to date for the audit." - Supervision/Managerial level

"It needs to be done. But has no real value to our business operations." - Leadership level.

While there are organisations that have understood the value of effective training & embraced newer ways of conducting them, such organisations are few. Most organisations continue to see training as a necessary but unimportant compliance checkbox.

This mindset ensures that while advances are made in improving manufacturing operations, equipment, systems, facilities etc., training continues to remain a static activity, living in the stone age.

While organisations are beginning to use new tools to deliver & manage training, the approach to training process continues to remain traditional - read SOPs, basic hands on training, annual GMP refreshers & retraining incase of deviations.The relevance of training topics & effectiveness of training is rarely evaluated by the company.

But, it is time for the life science sector to think outside the box when it comes to training. The need for change is fuelled by the following factors:

  1. Changing workforce expectations when it comes to skill development & flexibility-The current workforce is more focussed in personal skill development & understanding the value of what they learn. Putting them through the same training process will only lead to disengagement. They also want a more personalised & flexible approach to their training.
  2. Shortage of talent - Attracting & retaining talent will require creating training programs that are tailored to the company's immediate needs as well as engagement of the employee.
  3. Increase in the use of technology requiring newer skill sets - As organisations begin to adopt automated, AI/ML, VR, Big Data & Analytics solutions for their business, the employees will need to unlearn old skills & learn new ones e.g. data analysis, statistics, data governance & integrity, cybersecurity etc.
  4. Increased global & inter-disciplinary collaborations - With pharmaceutical/life science operations becoming increasingly global as well as advancement in technology, companies are now required to collaborate with various partners & industries. Developing not just technical skills but soft skills is becoming the need of the house for more effective collaborations.

Our mindset around training - the what, why, how & when - needs a radical change. We need to step out of the traditional box & find newer more engaging ways of implementing a training program that not only leads to compliance but also equips us with the skilled workforce ready to meet any change.

Murthy Tmmurthy

Quality Control Deputy Manager | Expertise in CSV, QMS, Audits,OOS Investigations, | Enhancing Quality & Compliance in Regulated Environments | Driving Operational Excellence.

8 个月

Absolutely! It's essential to move beyond mere compliance and focus on effectiveness in training. Empowering employees with the right skills and knowledge not only ensures regulatory adherence but also drives ROI and fosters professional development. Thinking creatively about training approaches can lead to more engaged and capable teams. Thanks for highlighting this crucial aspect!

回复

Absolutely agree! Training should be effective and empowering for employees, not just a box-ticking exercise. ?? Antiksha Joshi

Ramadas Bhat

Executive QA Director at Ionis Pharmaceuticals

8 个月

I concur with the analysis here. Very often and in majority of cases, training is being considered as a "check box" exercise and a documentation required during an audit. Such records absolutely do not show effectiveness and confirm whether trainee got some meaningful understanding. Training is always effective, in my opinion, when conducted as classroom type, it should be interactive and not just include few PowerPoint presentation slides. All participants should be fully engaged in the topics covered and learn from Q & A session. I have seen some companies switch to virtual training wherein few modules/topics are offered, and trainee could log in at any time listen to the presentation and answer few questions at the end. One should get more 80% score to "pass" the training. I don't think this is an effective approach either. Training is more effective when conducted live and there are lot of questions/answers and discussion. Bottom line, a company will be successful with its training program if it is not aimed at regulatory agency expectations but rather aimed at employee learning and development.

Monika Andraos, CQE

Data Integrity | Governance | Risk | EQ

8 个月

Great read Antiksha Joshi . Invest in your people, not just a select few who who may struggle to dissipate new knowledge to people outside of their teams. As the industry leans heavily towards short term contract work, they risk losing all that unspoken experience, if it’s not adequately documented.

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