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Home » Training Programs » Singapore and Asia Training Programs » Singapore Public Short Courses

Validation Practices

Course Details
Course code: 
SS6409

Aims:
This subject aims to extend the principles presented in SP6403 to practical outcomes. 

Outline Syllabus: 

  • Preparation of URS against FDS
  • Introduction to IQ OQ and PQ templates
  • Compiling IQ protocols
  • Compiling OQ protocols
  • IQ OQ execution and summary report
  • Deviation management
  • Assessing PQ/PV requirements
  • Developing PQ/PV protocols

Learning Outcomes:
On successful completion of this module, the student will be able to:

(1) Knowledge and Understanding

  • Describe the requirements of validation protocols.
  • Escribe the requirements of deviation management
  • List important regulatory guidance documents.
  • Describe the V model approach to validation documentation
  • Describe the role and purpose of validation master plans.
  • Define validation terminology; compare and contrast Commissioning and Qualification.
  • State the factors that can impact the commissioning and qualification process.
  • Use a risk based approach for identifying validation requirements and discuss the implications for the product
  • Describe the requirements for routine validation and revalidation.
  • Describe the requirements for annual product reviews.
  • State differences - retrospective review & re-validation.

Discipline skills

  • Compilation of Validation Master Plans.
  • Compilation of IQ and OQ Protocols.
  • Apply impact and criticality assessments.
  • Compilation of process validation protocols.
  • Compilation of a retrospective validation protocol.
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