Essentials for Medical Device Manufacturers by SkillsPlus International Inc. is an instructor-led training class, taught on-site in-house at client plant locations. This is useful as a new employee basics course, and can be used as a refresher course.
This class teaches employees how to identify the essential elements of QSR for beginning work in the medical device industry.
Upon class completion, students will be able to . . .
1. State the historical development of QSR regulations.
2. Explain the role and function of standard operating procedures.
3. Describe the personal role for contamination control.
4. Identify the sources of contamination.
5. List the common QSR documentation practices.
6. Explain material controls.
7. State the common practices of production and process controls.
8. Explain the importance of an adequate, appropriate, and sufficient building design.
9. State the requirements of equipment design and construction.
10. List the requirements for building, and equipment cleaning and maintenance.
11. Explain the role of the quality management system.
12. Explain the role of the laboratory.
- Heard on the street
- Past, present, and future
- Legal issues
- Personnel responsibilities
- Standard operating procedures
- Personal hygiene
- Process control
- Buildings and facilities
- Quality management system
Essentials for Medical Device Manufacturers by SkillsPlus International Inc
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