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Training can be defined as the act of acquiring skill, knowledge, or experience. In the context of GxP practices it is important to impart training to the employees and maintain up to date training records for the same. The process of Training ensures that the employees are competent to perform their jobs and responsibilities independently.


The job roles and responsibilities in the pharmaceutical and medical device industry involve many complex activities that can impact patients. These activities include but are not limited to:

  • Handling harmful chemicals and materials
  • Operating equipments
  • Appropriate storage of materials
  • Chemical analysis of materials
  • Ensuring data integrity as expected by the 21 CFR Part 11 & EU Annex 11 Regulations
  • Maintaining analytical records
  • Maintaining laboratory experimental records
  • Maintaining batch records
  • Regulatory knowledge
  • Quality Assurance and Quality Management knowledge (ISO 13485:2016)

All these activities need ‘continuous training’ for the adherence to the compliance. The employees should be trained on safety to perform their job responsibilities. The EU MDR mentions ‘continuous training’ as a part of Quality Management Requirements. Similar requirements are mentioned in ISO 9001:2008 and ISO 13485:2016.

Employees are trained on Standard Operating Procedures, Work Instructions, Templates and on the job training on necessary processes. The training assessment is performed to test the acquired knowledge by the employee. If the knowledge acquired is not satisfactory then the employee is retrained until he performs satisfactorily in the training assessment. A periodic retraining is scheduled for all the employees to refresh and update their knowledge on the topic.

Inadequate training and maintenance of training records can attract unfavorable observations under 21 CFR 211.25 from the FDA, causing loss of reputation and trust. Therefore, it is needless to say that Training is one of the most important key elements of the ‘Quality Management Process’.

Are you worried about managing employee Training too? Contact our experts who will guide you through how Scilife Training and Competence modules help you to automate Training Processes to meet the statutory requirements.


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