Training

Training Competent Authorities and, in particular, training Inspectors, is an integral and key activity of PIC/S. The training of GMP Inspectors has been one of PIC/S’ main focal points since the very beginning. Through this emphasis on training, PIC/S is able to achieve its mission.

A Key Feature of PIC/S

Harmonising GMP requirements through the PIC/S GMP Guide ensures uniform interpretation and application of GMP, however, focused training of GMP Inspectors is essential to achieve this goal. For this reason, training of GMP Inspectors is a key priority and activity of PIC/S. Recently, the PIC/S training tools, available to Inspectors, have been expanded and activated in areas such as Good Distribution (GDP) and Good Clinical Practices (GCP).

The variety of PIC/S training tools has progressively developed; starting with an Annual Seminar alone, before expanding to include the Joint Visits Programme (JVP), the establishment of Expert Circles in specialised areas and training courses, such as the New Inspector Training Course and Train the Trainer Course, which were developed in 2011 and 2014 respectively. The PIC/S Inspectorates' Academy (PIA) was established in 2014 and officially launched in 2016. 

PIC/S Training Tools

Currently PIC/S boasts various training and harmonisation tools, which have proved to be effective and are constantly being further developed and improved. These include:

Seminars Training Courses for New Inspectors
Expert Circles Train the Trainer Courses
Joint Visits Programme Training for Auditors
Coached Inspections Programme API International Training Programme
Other Non-PIC/S Training Events & Tools   

 

More information about all PIC/S training activities and tools is available at the PIC/S Inspectorates' Academy.

Sub-Committee on Training (SCT)

The Sub-Committee on Training (SCT) is in charge of all PIC/S activities in the field of training. It is currently chaired by Mr Boon Meow Hoe (Singapore / HSA). The SCT is the oldest Sub-Committee and exists since 1993 (first established as a “Working Group” under the PIC Committee of Officials, before becoming a Sub-Committee within the new PIC/S organisational structure). Its general mandate is to co-ordinate and monitor all PIC/S training activities, in particular Seminars and Expert Circles. Considering the expansion of Expert Circles and as training is only a (small) part of their activities, a separate Sub-Committee on Expert Circles (SCEC) was also established. 

SCT Mandate

  1. Identify training needs;
  2. Co-ordinate and monitor PIC/S training activities;
  3. Review the planning and organisation of annual training seminars, in particular:
    • propose and validate the seminar topic,
    • review the seminar programme,
    • assess the seminar report,
    • make recommendations for future seminars,
    • propose amendment to the Aide Memoire on the Organisation of Seminars (PI 003);
  4. Monitor the Joint Visits Programme and the Coached Inspection Programme and carry out a review of reports in order to identify divergences on GMP interpretation and inspection practices;
  5. Ensure the rotation of training between the various regions, taking into consideration the expansion of PIC/S;
  6. Consider proposals for co-operation with professional organisations (e.g. ISPE, PDA) in the field of training;
  7. Report back to the PIC/S Committee, as provided for in the Terms of References, and make proposals / recommendations.



PIC/S Working Groups operating under the SCT

Current PIC/S Working Groups active in the field of training include:

  • Working Group on ICH Q12 Training Materials

Upcoming Training Events

PIA logo 

Discover the PIC/S Inspectorates' Academy and all upcoming PIC/S training events.