Certificate

Equipment Validation / Qualification (IQ, OP & PQ)

Program code:

Credential:

Certificate

Duration:

8 Weeks

Delivery Mode:

Hybrid (Inquire about it), Live/Recorded Online, On-campus

Start Date(s):

January | May | September

Program Overview

Learning Outcomes

After successful completion of this course, students will be:

  • Able to understand current good clinical practices
  • Able to organize clinical studies
  • Able to coordinate clinical studies
  • Able to write procedures and protocols
  • Able to perform audit and inspections

Program Outline

Program Module

  • Module 1
    • Guidelines and Standards
    • Installation Qualification (IQ)
    • Operational Qualification (OQ)
  • Module 2
    • Performance Qualification (PQ) or Continuous Qualification (CQ)
    • Qualification Protocol Test Case Examples
  • Module 3
    • Power off / Power failure tests
    • Door Open tests
    • Temperature Distribution tests
    • Temperature Penetration tests
  • Module 4
    • Alarm testing
    • Loaded and Empty Mappings
    • Instrument / Equipment calibration
  • Module 5
    • Shelf mapping
    • Vacuum testing
    • Biological indicator test
    • Bowie Dick test
    • Vacuum leak test
    • Conductivity tests
    • Riboflavin removal testing
    • Controlled rate mapping
    • Qualification and Validation Service Reports, Protocols and SOPs

Admission Requirements

Who Should Attend

Anyone who wants to become the following should attend this webinar on equipment validation in the pharmaceutical industry:

  • Validation Specialist
  • Validation Engineer or Specialist
  • Process Engineer or Project Engineer
  • Quality Assurance Specialist
  • Quality Control Specialist
  • Maintenance Engineer
  • Maintenance Technician
  • Senior Validation Manager

Career Opportunities

  • Validation Assistant
  • Validation Specialists
  • Coordinators
  • Managers

Meet Your Instructors

Ready to Take the Next Step?

Start your application today and our admissions team will guide you through the next steps.