US FDA

Course Objective:

  • Overview of the FDA and intention of the 21 CFR Part 820 Quality System Regulation (QSR)
  • To understand the up-to-date requirements of 21 CFR Part 820 QSR and other Parts such as Part 11, Part 803 and Part 821
  • Working knowledge in application of the requirements
  • Preparation for FDA inspection

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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
Duration: 2 days Suitable for: This course i

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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.
  • Hands on experience to develop Software Validation documentation
Duration: 1 day Suitable for: Any person

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