Passing on the tools and means to audit pharmaceutical systems and manage pharmaceutical risks. Unlocking the full potential of health: strengthening the availability of quality medicines.
Training objectives
On completion of the training, participants will be able to: (i) use the concepts of quality control, quality assurance, quality management, standards, frameworks, etc.; (ii) apply ISO 17025 standards, WHO prequalification, etc.; (iii) describe the control process of the pharmaceutical chain; (iv) take part in the quality self-assessment of pharmaceutical products; (v) prepare an external assessment of pharmaceutical quality; (vi) apply the standards and frameworks in medicines management; (vii) define the concepts; (viii) manage the circuit and traceability of pharmaceutical products (risks, challenges and stakes); (ix) set up a quality-assurance approach in a medicines procurement centre; (x) set up a quality-assurance approach in a quality-control laboratory; (xi) set up a quality approach for procurement and stock management; (xii) set up a quality-assurance system for pharmaceutical products and manufacturers; (xiii) set up a quality-management system; (xiv) inspect pharmaceutical establishments; (xv) audit pharmaceutical systems; (xvi) supervise the actors of the quality-management system in the management of pharmaceutical products.
Programme
Module 1 — Quality management
- Introduction to quality management: general concepts and definition; quality, quality control, quality management, continuous improvement; the normative frameworks.
- The quality-management system: giving meaning to the quality organisation; documentation system; contract review.
- Resources and their management: personnel (management, training, qualification); equipment (management of the equipment park, calibration, verification and control charts); premises (identification of influencing factors and control of ambient conditions).
- Continuous improvement: high-added-value audits; relevant quality indicators; customer satisfaction; non-conformities, corrective and preventive actions; risk control; internal audit and management review.
- Setting up the quality-management system: the various approaches; the tools for implementing a quality approach; change management.
- Writing and documenting procedures, processes and methods: what is a document? life cycle, documentation diagnosis, role of a documentation system, the different types of documents, the “quality manual”; the quality of a document (understanding a text, level of detail, operating procedures, document modification).
Module 2 — Medicines quality assessment
- process for analysing the pharmaceutical criteria of products and manufacturers;
- impurity profile of pharmaceutical products;
- stability studies;
- setting up a QRM (“Quality Risk Management system”);
- raw-material standards, DMF analysis, CEP analysis;
- quality & marketing authorisation (MA);
- clinical and bioequivalence aspects in MA dossiers.
Module 3 — Quality audit in the medicines industry
- The fundamentals of quality audit: the “medicines” frameworks, their common points, their specificities and their positioning relative to ISO; the status and profession of auditor; communication techniques in auditing.
- Audit preparation and conduct: forming the audit team, choosing the type of audit, the checklists; investigation methods; closing meeting; report format and content; corrective actions and their evaluation.
- Audit against GMP or GCP frameworks (internal systems and processes): in-depth study of the framework, regulatory aspects and specificities of auditing an internal process/system and an investigator site; GMP: in-depth study and specificities of auditing an internal process/system including the QCL.
- Audit against GMP/ISO or GCP frameworks (external systems and processes): the frameworks and specificities of auditing API processes, excipient processes and packaging-article processes.
- Audit against GDP or GPvP frameworks: GDP — the framework and audit of distribution systems (finished products and clinical-trial batches); GPvP — the framework and pharmacovigilance rules, drafting a PV audit checklist and auditing a PV department.
- Audit of computerised systems in production and development: specificities of the frameworks, particularities of documentation, originality of the approach, applications of computer systems used in both development and production.
Module 4 — Risk management
- Context and stakes: the notion of risk; the different typologies of risk; the stakes of risk management.
- The risk-control approach: the systemic approach (the organisation as a system, the system and risks); towards global risk management — the IVTS process, risk mapping as the basis of the IVTS process, the IVTS process within the organisation.
- Methodology: risk identification; risk assessment; risk treatment; monitoring and continuous improvement; example of risk treatment.
- Implementation: setting up risk management; risk mapping (threats to the organisation); risk-management policy and implications; monitoring policy and action plan.
- Risk modification: risk reduction; risk transformation.
Module 5 — Setting up quality indicators
- usefulness and benefits of quality indicators;
- indicators: quality-management tools;
- steering quality control;
- steering for quality improvement;
- quantifying malfunctions and monitoring corrective actions.
Teaching method and learning techniques
Teaching method: interrogative and discovery-based method.
Learning techniques:
- case studies;
- individual and group exercises;
- field activities: technical site visits;
- the trainers involved have experience in the field of medicines management.
Participatory teaching takes into account each participant’s experience. For greater effectiveness, the pedagogical approach is concrete, participatory and encourages exchange. Technical input is enriched by shared discussions and analyses based on real situations. The intervention methodology aims to build specific tools and methods, shared by each professional and based on the needs identified throughout the support.
Course schedule
The support can take place over around three weeks.
Week 1 — Training: presentation of the process to participants in a meeting with the trainers (1 day); individual diagnosis of each participant’s situation on site (1 day); training on the approaches (2 days); drafting an individual and collective action plan (1 day).
Week 2 — Support: implementing the individual and group action plans, identifying levers and obstacles (2 days); implementing corrective and preventive actions (2 days); sharing experiences among participants in a brainstorming session (1 day).
Week 3 — Training validation: defining collective and individual progress plans (2 days); validating the progress plans (1 day); collective coaching session on the progress plans (1 day); site visit (½ day); individual coaching, a personalised meeting for each participant (1 day); review meeting, debriefing with the client’s managers, the trainers and the participants (½ day).
Contact and registration
Pharmaceutical Expertise and Training Division — CHMP
For any information or registration for this training course:
- Phone: +33 (0)4 73 98 24 81
- Email: contact@chmp.org
- Address: 13 rue des 4 Passeports, 63100 Clermont-Ferrand, France
You can also write to us via the Contact page.