Change Control and Change Management


In this program, we will focus on providing an in-depth understanding of performing change control and change management for organizations functioning within the life sciences industry (and related companies), including pharmaceutical and medical device manufacturers. Change control is a well-known good manufacturing practices (GMP) concept that focuses on managing change to prevent unintended consequences, maintain processes in a suitable state, such as in a “validated state,” and prevent any consequence of the change on the products’ Safety, Integrity, Strength, Purity and Quality (SISPQ). Change control has several different explanations, depending on the area to which the concept is applied.

Curriculum for this course:
Program Introduction
Course Overview 1 min 01 secs
Learning Objectives 1 min 31 secs
Glossary 1 min 10 secs
Change Management
Sources of Change Control 1 min 01 secs
Changes Requiring Change Control 1 min 10 secs
Where Does the Need for Change Originate? 48 secs
Formal Management of Change Control 1 min 10 secs
Company-Wide Approach to Change Management and Control 1 min 48 secs
Harmonization of Change Management and Change Control 1 min 02 secs
International Guidelines 1 min 10 secs
Defining Change Management vs Change Control in ICH Q10 1 min 10 sec
Communication Across Company Sites 1 min 05 sec
Advantages of Central Processing for Company-Wide Changes 1 min 26 secs
Change Management and the Lifecycle of a Product 1 min 09 secs
Change Management Application and ICH Q10 1 min 29 secs
Change Management and Product Lifecycle (ICH Q8, ICHQ9 and ICHQ10) 1 min 15 secs
PQS and Change Management 1 min 26 secs
Change Management: Knowledge and Risk Management 51 secs
Implementing ICH Q10 Change Management System for Continual Improvement 1 min 37 secs
Summary of Change Control and Change Management 58 secs
Final Assessment

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