Process Validation – Practical and Compliance Approach
The most crucial factor to achieve Business Growth in Pharma manufacturing nowadays, is Compliance with GMP norms, to increase the technical and financial strength of Manufacturing units. Currently, the aspect focused on by most Auditors, both internal, as well as external including regulators, is “Validation”, which is the key to all systems and processes in the pharmaceutical industry.
What you’ll learn
- Understand the practical implementation approaches of process validation.
- Understand Differences between Traditional Process Validation and Continued Process Verification.
- Evaluate your Process Validation Approach to ensure it meets current Regulatory Requirements.
- How to Save Costs – Compare Costs of Validation V/s Cost of Non-Compliance.
Course Content
- Introduction –> 1 lecture • 9min.
- Validation Master Plan (VMP) –> 1 lecture • 59min.
- Process Validation – Regulatory and Practical View –> 2 lectures • 3hr 45min.
- Process Validation – Key Questions and Clarifications –> 2 lectures • 26min.
Requirements
The most crucial factor to achieve Business Growth in Pharma manufacturing nowadays, is Compliance with GMP norms, to increase the technical and financial strength of Manufacturing units. Currently, the aspect focused on by most Auditors, both internal, as well as external including regulators, is “Validation”, which is the key to all systems and processes in the pharmaceutical industry.
As such, there are many open threads in the Traditional Process Validation approach, which need to be discussed, explained, and closed with the help of understanding the expectations of different Regulatory guidelines.
The course has multiple sections.
Section 1 is for stage 1 of the process validation which is “process design”. It explains how to implement the process design stage in the process validation.
Section 2 is for the “Validation Master plan”. This section elaborates on the following;
•Guideline Requirements – EU, FDA
•Validation Guidance by FDA
•7 Key Elements of VMP
•VMP elements discussion in detail
•Common Errors
Section 3 is for the Detailed “process validation” requirements. The session includes;
•Understanding different guideline expectations – EU, FDA, ANVISA, TGA, WHO, etc.
•Common regulatory expectations
•Traditional approach and Hybrid approach, CQA and CPP
•What is normally missing in process validation
•Concurrent validation approach
•Continued process verification vs product Quality Review
•Designing process validation protocol/Report
•Detailed difference between EU and FDA guide
Section 4 is for the “Stage -III Process Validation” Requirements. That means it elaborates on “continued process verification”. This session includes;
•Guideline Requirements – EU,FDA, WHO
•Understanding the FDA expectations about the Continued process verification
•Sampling Considerations
•Practical view to implement – Points to consider
•Difference between EU and FDA
•Learning from Warning Letters
Section 5 is for the key questions and clarifications related to process validation requirements. In this section two video lectures are available. Which will clear further key questions in line with regulatory guideline requirements.