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ISO 11137 Training

Our training program comprehensively addresses Gamma sterilization, focusing on meeting international standards such as ISO 11137 Part 1, Part 2, Part 3, and Part 4. These standards encompass validation, process control, and documentation to guarantee product safety and effectiveness. Adhering to these standards is essential for ensuring sterility assurance, reducing contamination risks, and preserving product integrity. This is critical for both patient safety and compliance with healthcare sector regulations.

Anchor ISO 11137

Course Objectives

At the end of the program participants should be able to do the following:
  • Understand the philosophy and principles of sterilization.

  • Aware of validation and routine control of the gamma radiation sterilization method and requirement.

  • Understand the key factors for sterilization process development.

Course Outline

Set the State- Overview:


•    Ice breaker- “Recognizing and identifying STERILE           product.
•    Objectives of the workshop.
•    Agenda.
•    Administrative arrangement.

 

Overview of Sterilization

•    Introduction.
•    Validation.
•    Process control & releasing.

 Key Factor of Sterilization Process Development.

•    Contamination control.
•    Microbiological testing.
•    Maintaining sterilization effectiveness
 

Target Audience

This program is very useful to participants who handles and are actively involved in Quality especially those who are QA/QC Lab technician, and QA/QC Executive.

Duration

2 full-day courses running from 8.30 am to 5.30 pm. Physical Training (On-site).

Register Here

Thanks for registering to our training program. See you there!

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