Change Control and Change Management
Description:
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 |
Conclusion
Final Assessment
Certification
Revision History
Major Update: The quiz was redesigned with new questions to better assess learners' knowledge. The quiz review function was not properly functioning and has been corrected to allow the learner to allow the learner to review incorrect and correct answers and feedback. The course was updated to modernize the design. | V2.0 |
Minor Update | V1.1 |
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