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US FDA, ISO 13485
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Course Objective:
- General requirements for Process Validation
- The linkage of the Process Validation with the standards and regulatory requirements
- Step-by-step on performing the Process Validation
- Hands on experience to develop Process Validation documentation
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Course Objective:
- General requirements for Software Validation
- The linkage of the Software Validation with the standards and regulatory requirements
- Step-by-step on performing the Software Validation.<
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