Process Validation Essentials

Aims:

This subject aims to extend students knowledge of Process Validation by using FMEA and HACCP to control what needs to be performed to comply with the PIC/s and FDA.

Outline Syllabus:

•  Integration of PV within VMP
• Reviewing the impact of the recent changes to PIC/S Annex 1 and FDA Guidance on Process validation
• Aseptic Validation for Sterile Processing
• Use of FMEA and HACCP in developing the PV Plan and Protocol
• Understanding Retrospective PV
• Interpreting and using process capability

Learning Outcomes:

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

(1) Knowledge and Understanding

• State the factors that can impact PV within the VMP structure
• Describe the recent changes to PIC/S Annex 1 and FDA Guidance on Process validation
• Discuss the requirements for Aseptic Validation for Sterile Processing
• Use the risk tools of FMEA and HACCP in identifying and defining the requirements for PV
• Understand how Retrospective PV can be achieved
• Discuss the use of process capability tools in PV and ongoing PQR’s

(2) Discipline skills

• Understand how PV integrates with VMP
• Reviewed the impact of the recent changes to PIC/S Annex 1 and FDA Guidance on Process validation
• Understand Aseptic Validation for Sterile Processing
• Used FMEA and HACCP to develop the PV Plan and Protocol
• Understand the requirements for Retrospective PV
• Understood how to interpret and use process capability calculations for PV