REF. ST04 – INTRA / INTER
PROCESSES
COURSE DESCRIPTION
International regulations that govern market authorization for Medical Devices require process control, including notably for sterilization processes.
By applying EN ISO 17665-1, control of the moist heat sterilization process for medical devices is ensured.
DURATION
1 day / 7 hours
IN-PERSON
VIRTUAL CLASSROOM
OBJECTIVES
- Understand the principles for validation and control of the moist heat sterilization process
- Be able to release sterile batches
- Be able to draw up specifications with the providers involved
- Control the impact of changes on the products
TARGET TRAINEES
Medical Device manufacturers/subcontractors, and more particularly:
- R&D
- Methods
- Production
- Quality Control – Release
PREREQUISITES
- Process qualification concepts
- Some familiarity with microbiology may help better understand that principles relative to the control of sterilization processes
TRAINING RESOURCES
- PowerPoint presentation handed out at the end of training
- Case studies
- Normative references
- Quizzes
COURSE CONTENT
Participants welcomed and presented/Course objectives/Presentation of the course content
- Sterilization processes – General aspects, process validation principles
- A few definitions
- Moist heat sterilization
- Description of the equipment
- Process steps
- Control parameters
- Validation methodology
- Process maintenance – revalidation
- Change control
- Subcontracting – Specifications
- 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%).
