Our training courses are given by expert trainers who have several years technical experience. All of our training courses are thus based on concrete examples found when working on site.
Validation/Qualification
Validation/Qualification
- Validation of cleaning processes
- Validation of laboratory systems and equipment
- Computerized systems validation
- Validation of automated systems and manufacturing equipment
- Validation of analytical methods
- Qualification of computer infrastructure
- Validation strategy and VMP
- Validation awareness
Quality/Regulations
Quality/Regulations
- Data integrity
- Computer quality according to ITIL requirements
- 21 CFR part 11- ERES – and annex 11 – managing computerized and automated systems
- OOS/OOT – Good practice for conducting investigation in a laboratory
- Quality Management System (QMS) – Medical Devices in the USA: 21 CFR 820
- ISO 9001, requirements and changes 2015
- Changes in standards required ISO 13485:2016
- QMS – Medical Devices in Europe: ISO 13485
- Drug/ Medical Device combination (Europe)
- Medical devices sterilization with ethylene oxide and according to ISO 11135 standards
- Technical documentation for medical devices (Europe)
- European rules and regulations for medical devices
- American rules and regulations for medical devices (FDA)
- Site Master File- GMP Part III
- APR – Annual product review
- Vigilance for clinical studies
- Good Pharmacovigilance Practices
- Studies for stability in the health field
- CTD, eCTD and NeeS: general principles, implementing regulatory procedures in Europe, the USA and throughout the world.
- Good Laboratory Practice (GLP)
- Good Clinical Practice (GCP)
- Good Laboratory Practice for pre-clinical trials
- GLP applied to the cosmetics industry
- GLP Cosmetics (ISO 22716): regulatory standards and requirements
- GCP applied to the cosmetics industry
- Good Practices for cleaning operation according to GMP
- Good Distribution Practice – GDP 2013
- GMP refresher training
- GMP: staff training on site (initial training)
- Medical Devices: differences between Europe, USA, Brazil, Japan
- GMP for drugs: general principles, feedback with experiences and news
- Quality by Design-ICH Q8
- ICH Q7: GMP Part II – active principles: general principles, feedback with experiences and news
- ICH Q10: PQS – pragmatic set up
- Change control/Modifications management
Risk Management
Risk Management
- FMEA: failure mode effects analysis for systems and equipment
- Risk analysis for systems and equipment validation (CVO-RM)
- Managing technical and computer risks
- Risk management in the health field
- Risk management applied to Medical Devices
Audits/inspections
Audits/inspections
- Preparing and succeeding your Japanese inspections – production sites (MHLW and PMDA)
- Preparing and succeeding your ANSM inspections for medical devices
- Preparing and succeeding your GCP inspections (FDA)
- Preparing and succeeding your American inspections (FDA) – production sites
- Suppliers audits
- Audit of automated and computerized systems suppliers
- Audit for suppliers, manufacturers, services
- Internal quality audit – tool for improvement and ensuring regulatory compliance (ISO 19011)
Project Management/Engineering
Project Management/Engineering
- Archiving: practical questions for health industries
- Steam autoclave sterilization
- LIMS: functions, carrying out a project and validation
- Automatic- initiation for non-specialists
- Computing- initiation for non-specialists
- Control technique management, computer testing and software acceptance
- Design review/design qualification
- URS and needs analysis: systems or equipment
- Automated systems: ISA88 in answer to QbD and continual improvement
- Project management in health industries
- GAMP 5: pragmatic use when ensuring regulatory compliance
Metrology
Metrology
- Metrology: uncertainty and its calculation
- Metrology from an organisational and operational point of view
- Metrology: basics
Statistics
Statistics
- Initiation to experiment plans and to ANOVA
- Initiation to statistics used in validation, test controls
Lean Six Sigma
Lean Six Sigma
- Lean Six Sigma – tools for decision making
- Lean Six Sigma – KAIZEN
- Lean Six Sigma – FIPOC-FIPEC
- Lean Six Sigma – VSM
- Lean Six Sigma – SMED
- Lean Six Sigma 5S
- Applying Lean Six Sigma in the health field
- Lean Six Sigma yellow belt
- Methods for problem solving in the health field