PIC/S Training Activities

Training of Competent Authorities, in particular GMP Inspectors, is at the very heart of PIC/S activities and has led over the years to the successful development of a variety of training tools.

About PIC/S Training

Harmonising GMP requirements through the PIC/S GMP Guide is not sufficient to ensure a uniform interpretation and application of GMP.  The training of GMP Inspectors is an essential tool to achieve this goal.  This is why the training of GMP Inspectors is a key activity of PIC/S.  Recently, PIC/S has also opened its training tools to Inspectors active in other areas such as Good Distribution (GDP), Good Clinical Practices (GCP) and Good Pharmacovigilance Practices (GVP). The various PIC/S training tools have been put in place progressively...

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Seminars

PIC/S Training Seminars for inspectors take place every year on a specific hot GMP-related topic.

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Expert Circles

PIC/S has formed several "Expert Circle" groups with the aim to enable inspectors to discuss and exchange information on specific technical areas of GMP...

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Joint Visits Programme

PIC/S inspectors from 3 different countries team up to observe GMP inspections in each country comparing inspection procedures and techniques as well as harmonising GMP interpretation.

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Coached Inspections Programme

A junior inspector teams up with an experimented inspector during a routine inspection.

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Training Courses for New Inspectors

Courses for new inspectors aim to develop the inspection skills necessary to assess GMP compliance against the PIC/S GMP Guide.

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Train the Trainer Courses

This course aims to train trainers on the skills necessary to develop and deliver internally to inspectors the materials from the New Inspector Training Course.

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Training for Auditors

This training developed by PIC/S and the EMA aims to train auditors who are in charge of auditing PIC/S and/or EEA GMP Inspectorates.

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API International Training Programme

The API International Training Programme offers training on GMP for Active Pharmaceutical Ingredients (API) to both manufacturers and inspectors.

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Non-PIC/S Training Events & Tools

A number of Professional Associations and International Organisations propose training tools and events which are open to participants from Regulatory Authorities.

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