Monday, February 27, 2012

Essentials for Medical Device Manufacturers - Live onsite QSR training class

In this original or refresher training, experience fun learning the regulations.

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
  • Contamination
  • Personal hygiene
  • Cleaning
  • Documentation
  • Materials
  • Process control
  • Buildings and facilities
  • Equipment
  • Validation
  • Calibration
  • Laboratory
  • Quality management system
For more information about this class:
Essentials for Medical Device Manufacturers by SkillsPlus International Inc

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  1. These are really good! I would feel very comforted knowing that those that are creating, very innovative, and potentially life saving medical devices go through this training. Thank you for sharing. I look forward to hearing more from you and sharing your ideas.

  2. Excellent blog very nice and unique information related to Medical Device Manufacturers. Thanks for sharing this information.
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