Managing Staff Training And GMP Compliance - Pharmaceutical Technology

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PharmTech Europe

Managing Staff Training And GMP Compliance
A case study is presented that describes how a software control system can ease the complex task of managing training needs across an international company, and improve GMP compliance by ensuring that employees are aptly qualified to perform their assigned tasks.

Pharmaceutical Technology Europe
Volume 22, Issue 12

The case study

How to assign training to each employee

For a company the size of Roche, which has many different objectives for employees, such as global guidance or company-specific GMP standards, it is necessary to merge employees to groups either in organisational or functional areas. From there, appropriate training can easily be set up. On the other hand, however, there are also local requirements that are pre-defined for a specific job. Today, Roche creates groups and assigns profiles to them using Pharmschul to develop suitable trainings. Different roles and functionalbased assignments can be combined to receive a complete set up for each employee.

Operating a packaging line, for example, presumes the employee has very special and detailed knowledge of technical documents tailored to one unit. Using the control system software, the company groups documents to document profiles according to different needs, or attributes certain documents to a specific job profile. Once a new document version is available in the DMS, a new draft training record is automatically created by Pharmaschul, and the training coordinator can then create the new record for the assigned group immediately. Different document profiles can be assigned directly to groups or persons, but the system can also connect document profiles to job profiles, which simplifies administration. It is also possible to group global guidance documents to dedicated global profiles, which can be applied to an entire organisational unit.

As Roche operates globally, employees will sometimes assume new responsibilities and training for such employees must be adapted accordingly. In this case, the training manager can easily assign the new, appropriate functional group to the person. The employee's 'old' specific job profile can then be attributed to another staff member and the required training is immediately visible. An additional interface between Pharmaschul and Roche's human resources database also ensures that when an employee leaves the organisation, he/she is automatically removed from all profiles and all planned training sessions to avoid confusion.

We also use the profiles to prepare annual staff training plans, which are created and assigned to the relevant groups. A formal report template is also available to print an annual training plan for a single employee, manually signed by line manager and employee.

Making sure employees know about new or updated SOPs

Standard Operating Procedures (SOPs) are necessary to introduce GMP standards into company-wide quality systems, and all employees need to be informed when a new or updated SOP is published. While this is easy in a small company, it is a rather more complicated task in a global entity like Roche. Because of this, we also introduced an additional web-based front-end for Pharmschul, called PharmschulWEB, which provides a validated solution for the completion of self-studies on procedures/SOPs, with electronic signatures.

When a new document in the DMS has been issued for training, the training manager attaches it to the relevant group, and an integrated email function then informs employees about the training. The email will contain a link to a web interface and the assigned document, which the employee can open, read and countersign with an electronic signature. In their personal screen, users can also obtain detailed information about their training status, including performed, planned and open trainings. We also use the web interface for refresher information about GxP and regulatory requirements or issuedriven training, such as retraining in response to deviation, defects or complaints.


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