GxP Training Compliance

Critical for company personnel to adhere to regulatory compliance

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SERVICES

Westbourne supports GxP for by supplying daily compliance reports

Early completion

Encourage early completion of all training as “best practice” and not to wait until the actual due date, or even close to that date. Anything that is due within 7 days should be considered pressing or urgent.

Holiday or otherwise unavailable

Identify people on holiday or otherwise unavailable. When this happens we work with the Training Coordinators to push out the training item due date to prevent it becoming overdue. In certain cases we can request that their GxP flag is turned off in HR systems until they return to work.

Unreasonably short due date

Identify training that has been assigned with an unreasonably short due date. Liaise with the company Training Coordinators to allow for a more realistic completion timespan.

Full classes, unavailable trainers, technical issues

Identify classes that are full, trainers that are unavailable or web based training with technical issues. Work with colleagues to help them overcome these obstacles.

Documentation ready, 5 days and new hires with reduced time

Identify documentation that is ready i.e. in 5 days and new hires with a reduced time to complete that course work and help them achieve this.

Identify laggards

Identify laggards i.e. people who have coursework or documentation sitting in their queue without any action, online course made available and no action after 1 week or any course with a due date coming up within 5 business days.

Approach

GxP Training Compliance

It is critical for company personnel to adhere to regulatory compliance in a pharmaceutical manufacturing environment to remain current with appropriate regulations. Compliance is a given for the regulatory inspectors and training completions associated with this should be 100%.

To help achieve this, our team analyses system-generated GxP Training reports on a daily basis and advises colleagues by email of any training items that are overdue or at risk of becoming overdue. Colleague managers are encouraged to oversee their employees’ commitment to compliance using our guidance as a useful tool. We include colleagues’ managers in any correspondence for visibility.

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• Encourage early completion of all training as “best practice” and not to wait until the actual due date, or even close to that date. Anything that is due within 7 days should be considered pressing or urgent.
• Identify people on holiday or otherwise unavailable. When this happens we work with the Training Coordinators to push out the training item due date to prevent it becoming overdue. In certain cases we can request that their GxP flag is turned off in HR systems until they return to work.
• Identify training that has been assigned with an unreasonably short due date. Liaise with the company Training Coordinators to allow for a more realistic completion timespan.
• Identify classes that are full, trainers that are unavailable or web based training with technical issues. Work with colleagues to help them overcome these obstacles.
• Identify documentation that is ready i.e. in 5 days and new hires with a reduced time to complete that course work and help them achieve this.
• Identify laggards i.e. people who have coursework or documentation sitting in their queue without any action, online course made available and no action after 1 week or any course with a due date coming up within 5 business days.
• Enable the right engineers and IT professionals to work on your tasks as soon as possible.

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