Product Quality Review (Annual Product Quality Review)

Product Quality Review

What you'll learn

Brief understand about the Product Quality Review in pharmaceuticals

Compliance to regulatory requirements for PQR

Understand in brief about Product Quality review and continued process verification. Both are different

The key questions related to PQR will help you to understand and clear the subject and avoid potential errors in future

Requirements

The person should be full focussed during the session.

Description

The Product Quality Review is part of the Quality management system requirements.The first lecture is related to process capability and process capability index. This will help viewers to understand this concept very clearly because as a part of PQR, it is required to evaluate.The second lecture is on Pharmaceutical Quality system. This lecture constitutes below discussion•Importance of topic and Agenda•Know your Trainer•Understanding the different guidelines•ICH Q10 Objectives•Life Cycle Approach•Management Responsibility•Elements of Pharmaceutical Quality System•Key messageThe third lecture is on Key questions related to PQR. Due this this lecture, the participants will clear their concepts and avoid errors in future.The fourth lecture is on Product Quality Review. The lecture will discuss in detail about PQR expectations. This session includes below points - •Importance of topic & Know your Trainer•Expectations about PQR from different regulatory agencies•Specific key expectations from regulatory guides (FDA,WHO)•Elements of product Quality Review•Practical approach towards each elements•Role of statistical evaluation in PQR•Practical examples for detailed understanding about statistical evaluations•Broad Difference in expectations between EU and FDA•Common non conformance identified in PQRThe last lecture is on continued process verification. Many people think that, continued process verification and PQR are same. But both are different.

Overview

Section 1: Introduction

Lecture 1 Introduction

Lecture 2 Pharmaceutical Quality System (PQS)

Lecture 3 Product Quality Review (PQR) Key Questions and Answers

Lecture 4 Product Quality Review (PQR)

Lecture 5 Continued Process Verification

Professionals of pharmaceutical industry, Quality Assurance, Quality control (Analytical laboratory), production, engineering, R&D, development, investigation team, compliance team etc.