REF. MQ06 – INTRA / INTER
QUALITY SYSTEM
COURSE DESCRIPTION
Applicable regulations require control of the production of medical devices and in vitro diagnostic medical devices placed on the market to ensure their safety and performance.
The manufacturer must demonstrate that its processes are able to reproduce expected results. The validation phase is therefore crucial as it guarantees compliance with the requirements throughout the entire manufacturing cycle.
DURATION
1 day / 7 hours
IN-PERSON
VIRTUAL CLASSROOM
OBJECTIVES
- Become familiar with applicable regulatory and normative requirements
- Learn the process validation methodology
- Establish the related documentation system
- Identify the actions required to maintain a “validated” status
TARGET TRAINEES
Manufacturers of In Vitro Diagnostic Medical Devices, and more particularly employees in the following departments:
- Methods/Industrialization/Validation
- Quality Assurance
- Production
PREREQUISITES
Familiarity with ISO 13485 and a production environment is recommended
TRAINING RESOURCES
- PowerPoint presentation handed out at the end of training
- Case studies
- Experience sharing
- Quizzes
COURSE CONTENT
Participants welcomed and presented/Course objectives/Presentation of the course content
- Normative and regulatory framework
- Definitions
- Process
- Methodology
- Scope of the qualification
- Validation master plan
- Process validation
- QC/IQ/OQ/PQ
- Documentation
- Maintaining a “validated” status
- Validation in an industrial context
- Risk analysis
- Process control
- Transfer to production
- Action plan
- Summary/Q&A
- Course evaluation and conclusion
EVALUATION METHODS
- Course evaluation quiz
- Satisfaction survey
- Attendance certificate
This training is assessed based on an evaluation of each individual’s acquisition of knowledge via quizzes during and at the end of the program (success criteria >= 75%).
