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.
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...
PIC/S Training Seminars for Inspectors take place every year on a specific hot GMP-related topic.
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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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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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A junior Inspector teams up with an experimented Inspector during a routine inspection.
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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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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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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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The API International Training Programme offers training on GMP for Active Pharmaceutical Ingredients (API) to both manufacturers and inspectors.
MoreA number of Professional Associations and International Organisations propose training tools and events which are open to participants from Regulatory Authorities.
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