PIC/S Pluriannual Training Schedule for the period 2009-2012 : 
Annual Seminar
The annual PIC/S training Seminar is attended by GMP inspectors from Participating Authorities and other interested Drug Regulatory Authorities. The Seminar is hosted by a different PIC/S Participating Authority each year. Each Seminar focuses on a particular aspect of GMP, with the aim of providing training and harmonisation in the field.
Year |
Seminar Topic |
Country / Authority |
| 2013 | Global Supply Chains and GMP Compliance |
Canada / HPFBI |
| 2012 | Qualification and Validation | Ukraine / SAUMP |
| 2011 | Good Pharmaceutical Inspection Practices | South Africa / MCC |
2010 |
GMP Inspection of Manufacturers of Traditional / Herbal Medicinal Products |
Malaysia / NPCB |
2009 |
Inspection of aseptic & sterile manufacturing |
Sweden / MPA |
2008 |
Good Distribution Practice |
Poland / MPI |
2007 |
Inspection of Manufacturers of Solid Dosage Forms |
Singapore / HSA |
2006 |
Quality risk management and related ICH topics |
Germany / ZLG |
The proceedings of these Seminars are subsequently published on CD-Rom, and are available for purchase at the PIC/S Secretariat.
The annual PIC/S Seminar usually results in the formation of a working group to develop a draft Guidance or Recommendations. For example, the 2004 Seminar on Active Pharmaceutical Ingredients (APIs) resulted in the preparation and the issuing of the PIC/S Aide-Memoire on the inspection of APIs.
Expert Circles
PIC/S has formed several Expert Circles to enable specialised inspectors to discuss and exchange information in a specific area of GMP. Expert Circles on Active Pharmaceutical Ingredients (APIs), Computerised Systems, Human Blood & Tissue and Quality Risk Management (QRM) are currently active and meet at least annually. The aim of the Expert Circles is to develop guidance documents (e.g. recommendations or aide-memoires) or to draft / revise Annexes to the GMP Guide. Expert Circle meetings are open to inspectors from PIC/S Participating Authorities and Applicants, but also to inspectors from non-PIC/S Regulatory Authorities (provided that the meeting also provides training to inspectors).
Joint Visits Programme
“Another avenue for the training of inspectors from PIC/S Participating Authorities is the joint visits programme for the training of inspectors. Under this program, three inspectors from three different countries are teamed up to observe typical inspections in each country with a view to comparing inspection procedures and techniques. Any differences in inspection procedures and techniques are reported to the PIC/S Working Group on Training for appropriate action. Joint visit groups are also encouraged to recommend specific training needs for inspectors, including topics for future PIC/S Seminars” (extract from the PIC/S Blueprint, paragraph 111)
Coached Inspections
In order to provide training to new inspectors or inspectors who wish to improve their inspection skills in a specific field, PIC/S introduced in 2009 a programme on coached inspections. The programme consists in teaming up a junior inspector with an experimented inspector during a routine inspection. The programme is open to inspectors from Participating Authorities and Applicants.
Traininig Courses for New Inspectors
PIC/S has started with providing a training course for new GMP inspectors: the first such course was organised by the Irish Medicines Board in Dublin on 24-28 January 2011, the second will take place on 22-26 August 2011.
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NON PIC/S TRAINING EVENTS / TOOLS
The International Society of Pharmaceutical Engineers (ISPE) and the Parenteral Drug Association (PDA) both propose training sessions and events all over the year and around the world, which are open to participants from Regulatory Authorities.
Kindly consult below the webpages dedicated to training of these organisations:
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The Prequalification Programme of the World Health Organization (WHO) has also developped the following training material, which could be useful for GMP inspectors:
Basic GMP Training
This training package covers material on general GMP including norms and standards for Premises, Equipment, Materials, Documentation, Personnel, Validation and other aspects.
Supplementary Training Modules for experts
These modules provide training on Validation, Water systems and Heating, Ventilation & Air Conditioning (HVAC) systems.
Various resources from recent WHO training events (meetings / workshops) can also be downloaded from here.
