Process Validation For Pharmaceutical Industries

Process Validation - Practical and Compliance Approach

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

Requirements

The person should be full focussed during the session.

Description

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 ErrorsSection 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 guideSection 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 LettersSection 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.

Overview

Section 1: Introduction

Lecture 1 Process Validation Stage -1 "Process Design"

Section 2: Validation Master Plan (VMP)

Lecture 2 Validation Master Plan

Section 3: Process Validation - Regulatory and Practical View

Lecture 3 Process Validation - Regulatory and Practical View

Lecture 4 Continued Process Verification

Section 4: Process Validation - Key Questions and Clarifications

Lecture 5 Key Questions and Clarifications - Part I

Lecture 6 Key Questions and Clarifications- Part II

Managers and Decision-makers in Pharmaceutical, Companies and Contract Manufacturing Organizations ,Professionals from Manufacturing, QC and QA,Regulatory, Compliance, Supply Chain ,All those involved in Export of Pharmaceutical Products to Regulated Markets, Auditors – Internal, External, Third-Party Auditors