Process Validation For Pharmaceutical Industries

Process Validation For Pharmaceutical Industries, available at $44.99, has an average rating of 4, with 6 lectures, based on 2 reviews, and has 16 subscribers.

You will learn about 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 This course is ideal for individuals who are 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 It is particularly useful for 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.

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Summary

Title: Process Validation For Pharmaceutical Industries

Price: $44.99

Average Rating: 4

Number of Lectures: 6

Number of Published Lectures: 6

Number of Curriculum Items: 6

Number of Published Curriculum Objects: 6

Original Price: ₹1,799

Quality Status: approved

Status: Live

What You Will 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

Who Should Attend

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

Target Audiences

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

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.

Course Curriculum

Chapter 1: Introduction

Lecture 1: Process Validation Stage -1 "Process Design"

Chapter 2: Validation Master Plan (VMP)

Lecture 1: Validation Master Plan

Chapter 3: Process Validation – Regulatory and Practical View

Lecture 1: Process Validation – Regulatory and Practical View

Lecture 2: Continued Process Verification

Chapter 4: Process Validation – Key Questions and Clarifications

Lecture 1: Key Questions and Clarifications – Part I

Lecture 2: Key Questions and Clarifications- Part II

Instructors

Hitendrakumar Shah
Pharmaceutical cGMP Compliance Consultant, Trainer & Auditor

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2 stars: 0 votes
3 stars: 1 votes
4 stars: 1 votes
5 stars: 0 votes

Frequently Asked Questions

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