Video Training

PIC/S has started video-recording a number of its training events, which can be viewed below by PIC/S Inspectors-only. Login is required.

Please note that all PIA materials are copyright protected and must be considered as such, even without an explicit copyright protection ©. They cannot be reproduced, in part or in full, without the PIC/S Secretariat’s prior permission and, where applicable, other concerned copyright holder(s). Materials are for the personal use of PIC/S inspectors and of those to whom permission has been granted by PIC/S. By acceding to this webpage, users commit to abide to the above-mentioned conditions.

Practical tips:


> Please use the rolling menu to select the videos of the different sessions of each training event.                                           

> Please rate the training videos and share your feedback by using the star system.   

7 August 2018

Short Videos on Key Inspector Communication Skills

This is a series of short videos on key communication skills for inspectors in the form of video recordings made in August 2018 by Paul Hargreaves (UK / MHRA). The recordings are for inspectors-only and consists of 3 parts, namely (i) questioning skills (ii) listening skills and (iii) communication across boundary skills.

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15 September 2017

EMA-EDQM Webinar Water For Injections by Non-Distillation Technologies

This is a recording of a webinar organised by EMA and EDQM on Water for Injection which took place on 15 September 2017. The webinar for inspectors-only consists of 2 parts, namely (i) an overview on the revised Ph. Eur. monograph for Water for Injections and (ii) Overview of the ‘Questions and answers on production of water for injections by non-distillation methods – reverse osmosis and biofilms and control strategies’ published on the EMA website.

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13 - 15 September 2017

PIC/S Seminar 2017 on Quality Control Laboratories: How to Inspect, Taipei (Chinese Taipei)

This Seminar is dedicated to quality control of QC labs (Quality Control Laboratories) and consists of a mix of presentations and workshops. The Seminar, for Inspectors-only, covers basic concepts, current and trending regulatory requirements, as well as specific quality issues which have impacted on the regulatory compliance of QC labs. The programme includes topics related to GMP inspections on QC labs, in particular for physical, microbiological and analytical labs, as well as OOS/OOT investigation, data integrity issues and aspects of test methods validation and verification in the context of technical transfer.

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13 September 2017

GMP Inspection of Microbiological Laboratories: Supporting Training Videos | Part of PIC/S Seminar 2017

This training, part of the programme of the 2017 PIC/S Seminar in Taipei on "Quality Control Laboratories: How to Inspect" includes a presentation with case studies of microbiological contamination of sterile products as well as training videos to assist with the training of new inspectors, or inspectors not familiar with microbiology laboratories.

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13 September 2017

GMP Inspection of Physical Laboratories: Supporting Training Videos | Part of PIC/S Seminar 2017

This training, part of the programme of the 2017 PIC/S Seminar in Taipei on "Quality Control Laboratories: How to Inspect" includes a presentation on key questions the inspector could ask during an inspection of physical testing laboratories as well as training videos to assist with the training of new inspectors, or inspectors not familiar with physical testing.

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5 - 7 April 2017

PIC/S 8th Expert Circle on API Meeting and Advanced Training on API Inspections, Melbourne (Australia)

This advanced API training, for Inspectors-only, has been developed by the PIC/S Expert Circle on API within the frame of the PIC/S International API Training Programme. It offers the opportunity to learn about regulation of small versus large molecule manufacturing. Other topics discussed include regulatory approaches to atypical API’s, continuous processing and the EU guidance on good distribution practices. The programme included 2 workshops on atypical APIs and on the review of the PIC/S Aide Memoire on the inspection of APIs (PI 030-1).

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24 - 28 October 2016

PIC/S 22nd Expert Circle Meeting on Blood, Tissues, Cells and ATMPs (Hong Kong)

This 22nd PIC/S Expert Circle meeting on Human Blood, Tissues, Cells and ATMPs (Advanced Therapies Medicinal Products), hosted by Hong Kong SAR / PPBHK, focused on "Inspecting human blood, tissue and cell products & ATMPs – Experience exchange". The objectives of the meeting were to (i) discuss contemporary issues and mapping competences of PIC/S Participating Authorities in the field of blood, blood components, plasma derivatives, cells and tissues with particular focus on ATMPs; (ii) review of the different initiatives and current guidance documents on ATMPs and blood establishments; (iii) share experiences between inspectors to improve consistency among inspectors in the field of blood establishments and ATMP facilities inspections; and to (iv) exchange ideas and foster collaboration among inspectorates, academia and stakeholders.

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26 - 28 September 2016

PIC/S Expert Circle on QRM Advanced Training Course

This training course on the use of advanced QRM (Quality Risk Management) organised by the PIC/S Expert Circle on QRM was delivered in 2014 in Japan, hosted by Japan / PMDA; in 2015 in Los Angeles, hosted by US FDA; and in 2016 in London hosted by the European Medicines Agency (EMA). This course has been developed to enable GMP inspectors to effectively inspect QRM activities on site at an advanced level and effectively use the PIC/S Recommendation in relation to risk-based GMP inspection planning (PI 037-1) as well as the PIC/S Aide Memoire on QRM (PI 038-1). The objective is to provide advanced training on how to critically inspect the implementation and use of QRM during regulatory inspections; (ii) how to critically inspect at an advanced level Risk Assessments at manufacturing sites; and (iii) how to effectively use the risk-based GMP Inspection planning tool (PI 037-1).

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26 - 30 October 2015

PIC/S 21st Expert Circle Meeting on Human Blood, Tissues, Cells and ATMPs, Rome (Italy)

This 21st PIC/S Expert Circle meeting on Human Blood, Tissues, Cells and ATMPs (Advanced Therapies Medicinal Products), hosted by Italy / AIFA, focused on "Issues and challenges in inspecting human blood, cells and tissues derived products and ATMPs". The objectives of the meeting were (i) to discuss contemporary issues and mapping competences of PIC/S Participating Authorities in the field of blood, blood components, plasma derivatives, cells and tissues with particular focus on(ATMPs); (ii) future objectives and mandate of the PIC/S Expert Circle on Human Blood, Tissues, Cells and ATMPs (iii) review of the different initiatives and current guidance documents on ATMPs; (iv) basic agreement on key principles for ATMPs; the right balance between facilitating and managing; (v) sharing experiences between inspectors to improve consistency among inspectors in the field of blood establishments and ATMPs inspections.

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20 - 22 October 2015

PIC/S 7th Expert Circle on API Meeting and Advanced Training on API Inspections, Strasbourg (France)

This advanced API training, for Inspectors-only, has been developed by the PIC/S Expert Circle on API within the frame of the PIC/S International API Training Programme. It offers the opportunity to learn about data integrity issues, including root causes, inspection of IT systems and collection of evidence as well as practical examples on FT-IR software and on GC. Other topics include contamination by genotoxic impurities, chemical reference standards, most frequent API deficiencies as well as international collaboration, covering ways of selecting API sites to be inspected and re-inspected. Case studies are given on dealing with show/shadow factories, data integrity failures in a computerised environment and in a paper production environment as well as on cross contamination/impurity issues.

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1 January - 31 December 2015

PIC/S - PDA ICH Q7 Training

This general API training, developed by the PIC/S Expert Circle on API and PDA (Parenteral Drug Association), consists in technical experienced based training courses which were developed for GMP Inspectors and API industry on the requirements of ICH Q7. The trainings took place in key locations around the world in response to the urgent need to train API inspectors and industry. The training video - which offers a best-of of the various PIC/S - PDA Q7 trainings delivered in Brazil, Korea (Republic of), India, China and Puerto Rico -  covers all sections of ICH Q7, including some practical examples. Observations from inspections and areas where deficiencies are commonly found are highlighted. Additional presentations on key issues such as e.g. data integrity have been added.

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27 - 28 October 2014

PIC/S - EMA Training for Auditors

The training for Auditors has been developed by PIC/S and the EMA (European Medicines Agency) for Auditors operating in the frameworks of the PIC/S Joint Re-assessment Programme (JRP) and the EEA Joint Audit Programme (JAP). These programmes regularly audit the Quality Systems of GMP Inspectorates from PIC/S Participating Authorities, respectively EEA Authorities. The course comprises an overview of the JAP and JRP Programmes and their benefits; links and differences to other auditing programmes; planning and preparation of audits; conduct of audits; observed inspections; audit closing meeting; audit reporting and further steps of the audit process; audit checklist; soft skills and audit techniques. The course also includes a number of workshops as well as a panel discussion.

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19 - 21 May 2014

PIC/S 6th Expert Circle on API Meeting and Advanced Training on API Inspections, Rome (Italy)

This advanced API training, for Inspectors-only, has been developed by the PIC/S Expert Circle on API within the frame of the PIC/S International API Training Programme. It offers the opportunity to learn about process validation, sampling operations and cleaning validation issues. Other contemporary issues such as data integrity issues, falsification and manipulation during API inspections, heparin inspections as well as benefits, risk, complexity of international collaboration are covered. Workshops on examples of process validation protocols & reports from API inspections, sampling operations, cleaning validation and counterfeiting are included.

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8 - 9 November 2012

Rapid Microbiology Methods (RMM) Training by PDA in Co-operation with PIC/S, Barcelona (Spain)

This RMM training event, open to both industry and regulators (assessors & inspectors), offers the opportunity to learn about the latest technologies (as of 2012). It covers topics such as 21st Century Microbiology in Support of Product Quality and Patient Safety / Regulatory Perspectives / Growth-based Detection and Counting / Gene-Disc; PST-based Detection of Organism / MALDI TPF Identification / FACSMicroCount / Flow Cytometry for Counting / Fluorescent Staining-based Systems / Laser Induced Fluorescence - Real-time Particle Detection / Detective and Identification of Single Microorganism by Raman Spectroskopy as well as visits of booths of companies presenting.

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17 - 19 September 2012

PIC/S 5th Expert Circle on API Meeting and Advanced Training on API Inspections, Washington DC (USA)

This advanced API training, for Inspectors-only, has been developed by the PIC/S Expert Circle on API within the frame of the PIC/S International API Training Programme. It offers the opportunity to learn about sterile and biotech APIs. Topics covered include specific challenges faced when using sterile and biotechnology processes to manufacture APIs, along with a series of workshops on the enhancement and development of current guidelines and regulations regarding these topics. A panel discussion was held to present and discuss current challenges regarding the issues in heparin manufacturing and the complexity of inspectional approaches for such manufacturers.

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12 - 14 October 2011

PIC/S 4th Expert Circle on API Meeting and Advanced Training on API Inspections, Singapore (Singapore)

This advanced API training, for Inspectors-only, has been developed by the PIC/S Expert Circle on API within the frame of the PIC/S International API Training Programme. It offers the opportunity to learn about falsification and counterfeit products, including counterfeit drug detection and the use of analytical techniques in confirming authenticity of APIs. Other topics covered are API GMPs applied to a supply chain from API starting materials to drug manufacturers, a pragmatic approach to impurities as well as API GMP inspections and compliance issues. Workshops on cases of falsification and manipulation as well as cases of control of starting materials & manufacturing process, cross-contamination and stability are included .

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7 - 9 September 2010

PIC/S QRM Training, Warsaw (Poland)

This QRM training was organised by the PIC/S Expert Circle on QRM and Poland / MPI. It was the first training of this type in the history of PIC/S and was planed as the pilotage basic training in scope of QRM for GMP Inspectors. The objective of the training is to apply QRM principles in the same way, in order to get harmonization in all countries. This training offers background knowledge and skills to provide the QRM Training in their Competent Authority. This training of trainers should be the basis for use of unified QRM approach in all PIC/S Participating Authorities.

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