Certificate

Equipment Validation / Qualification (IQ, OP & PQ)

Program code:

Credential:

Certificate

Duration:

Delivery Mode:

Start Date(s):

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 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

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

Validation Assistant
Validation Specialists
Coordinators
Managers