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.
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> 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. |
This training for Auditors has been developed with the frame of EU Joint Action EU4H11 jointly by PIC/S, the European Commission (EC) and the European Medicines Agency (EMA) 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 assess the compliance of the GMP Regulatory Compliance programme from PIC/S Participating Authorities, respectively EEA Authorities. The course comprises an overview of the JAP and JRP programmes and common checklist; planning and preparation of audits; conduct of audits; observed inspections; audit closing meeting; audit reporting; practical application and interpretation of the audit checklist; soft skills, audit techniques and non-technical aspects. The course also includes Q&A.
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The Seminar focuses on ‘Inspection of the Pharmaceutical Quality System (PQS)’. It consists of interactive panel discussions, presentations and workshops aiming at enhancing Good Manufacturing Practice (GMP) Inspectors’ skills in the area of inspection of Product Quality Reviews and Annual Product Quality Reviews, Deviation & CAPA Management, Change Management and Management of OOS Investigations. This involves discussions on how Inspectors can coordinate the outputs of these inspected areas to assess the effectiveness of the PQS.
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The training for Auditors has been developed jointly by PIC/S, the European Commission (EC) and the European Medicines Agency (EMA) 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; 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, audit techniques and non-technical aspects. The course also includes Q&A and panel discussions.
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This Webinar of the PIC/S Expert Circle on Quality Risk Management (QRM) hosted by the UK Medicines and Healthcare Products Regulatory Agency (MHRA), for Inspectors-only, consisted in a training and meeting. It allowed to provide Inspectors with an up to date understanding of significant changes in QRM guidance for industry, inspectorates and Inspectors. Topics discussed included (i) the ongoing revision of ICH Q9 on Quality Risk Management (ii) the PIC/S Recommendation Paper on Evaluating and Demonstrating the Effectiveness of the Pharmaceutical Quality System (PQS) with respect to Risk-based Change Management (PI 054-1), and (iii) the ongoing revision of the PIC/S Aide Memoire on inspecting the Implementation of QRM.
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This Virtual Seminar is dedicated to GMP Assessment Approaches in Post COVID-19 Era. It consists of interactive presentations, panel discussions and workshops to identify current status of various distant assessment techniques from the Regulatory Authorities and industry perspectives. The Seminar, for Inspectors-only, also recognizes the importance of promoting mutual reliance among Regulatory Authorities by sharing information on GMP inspection results. It aims to prepare for a new trend of GMP assessment approaches in post COVID-19 era.
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This Webinar organised by the PIC/S Working Group on Training Material for ICH Q12 (Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management ICH Q12), for Inspectors-only, focused on discussions between Inspectors on training needs and draft tools developed by the PIC/S Working Group in order to facilitate and accompany implementation of ICH Q12. It was supported by ICH Funding of Regulatory Training.
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This Virtual Seminar is dedicated to Distant Assessment of GMP Compliance and places special emphasis on real-time interactive assessment using ITC (Information Technology and Communication) tools. Distant assessment in the context of the Seminar is an interchangeable term with remote or virtual inspections. The Seminar, for Inspectors-only, provides presentations and discussions on the implementation of distant GMP assessment/inspection activities in different jurisdictions and on information security in virtual real-time communications. It includes discussions on the sharing of experiences in off-site GMP assessment/inspections.
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This Webinar meeting of the PIC/S Expert Circle on Quality Risk Management (QRM) hosted by the Turkish Medicines and Medical Devices Agency (TMMDA), for Inspectors-only, included some training aspects and allowed to discuss updates and progress on applicable QRM guidance. In particular, it led to important developments on (i) the revision of the PIC/S Aide Memoire on inspecting the implementation of QRM (PI 038-1); the QRM Curriculum and the QRM e-Module being developed for the PIC/S Inspectorates’ Academy (PIA); the PIC/S Recommendation Paper on Evaluating and Demonstrating the Effectiveness of the Pharmaceutical Quality System (PQS) with respect to Risk-based Change Management (PI 054-1 (Draft 1)); as well as ICH Q12 and its relevance for GMP Inspectors, in particular training under development by the PIC/S Working Group on ICH Q12 Training Materials.
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This Seminar is dedicated to Quality Assurance of Sterile Medicinal Products - PIC/S GMP Guide Annex 1. It consists of interactive discussions, presentations, and workshops. The Seminar, for Inspectors-only, provides a further understanding of Annex 1 based on issues discussed during its ongoing revision and through a case study of sterility assurance. It also addresses how to make science and risk based decisions related to product quality during GMP inspections.
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This 1st PIC/S Expert Circle Meeting on Control of Cross Contamination in Shared Facilities, hosted by Chinese Taipei / TFDA, for Inspectors-only, focused on PIC/S Good Manufacturing Practices on control of cross contamination in shared facilities. The objectives of the meeting were to discuss (i) training and education in the use of the Health Based Exposure Limit guide and relevant sections of PIC/S GMP Chapters 3 & 5 to help ensure a consistent application of expectations across PIC/S members; (ii) awareness of the need for a proportionate risk-based approach dependent on the extent of hazards present and (iii) share experience and knowledge on inspection of cross contamination risks and Health Based Exposure Limit (HBEL) assessments.
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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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