Change Control - New Aspects and Best Practices

Change Control -  New Aspects and Best Practices

Vienna, Austria

Course No 9121


This conference already took place.

If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail:


Richard M. Bonner, ECA Chairman, formerly with Eli Lilly, UK
Dr Hiltrud Horn, Horn Pharmaceutical Consulting, Germany
Aidan Madden, FivePharma, Ireland
Rico Schulze, GMP Inspectorate, Germany


During this course, you will learn all relevant aspects to implement and/ or improve your Change Control System fulfilling the regulatory GMP requirements. You will get to know the whole process from initiation over implementation to regulatory submissions. You will also have the possibility to work on practical examples.

Change control systems should be an integral part of the quality management system of each company. Their task and aim is to ensure that all announced or requested changes are carefully checked and completely documented and authorised.


Before starting implementing the change, many question need to be answered like:
How is the change classified
Is it a variation or a change
Who needs to be informed
What are the regulatory consequences

A sound change control system is used to manage changes of all types. The Change Control process is necessary to prevent inappropriate changes from occurring. All GMP-relevant changes should only be made with a complete review and approval of the QA and any other department that might be impacted by the change.

Only if all functions involved in the process are working together and know what needs to be considered, the change control process will run smoothly and fast enough to benefit from the change.

It is of high importance to know all relevant aspects of the whole change control process and the consequences a change might have.

Target Group

This course is designed for all personnel involved in the Change Control process at their company and for decision makers who want to improve the existing systems.

It is addressed to persons from Manufacturing, Quality Control and Quality Assurance but also from from Regulatory Affairs.


Change Control: GMP Requirements
European Requirements
When to contact authorities
Changes in key personnel
SMF changes
Change Control in the light of inspections

How to handle Changes in US
21 CFR 314.70
Changes to an approved NDA and ANDA
Examples (PAS, CBE, AR)
Annual Report
Comparability Protocol (US) vs. Change Management Protocol (EU)

The Change Control Process through the Product Life Cycle (Part 1):
How to manage it, who’s involved and when does it
The importance of Change Control
GMP-compliant Change Control
General Requirements
Implementation of Changes

What’s a Change and how to proceed
Technical changes: Change Control or not
How to deal with software updates
Risk Analysis in Change Control
Classification of Changes
How to document changes

The Change Control Process through the Product Life Cycle (Part 2):
Risk Management and Quality Metrics
The final review and evaluation after implementation
CC effectiveness check
Applicable KPIs and Quality Metrics

Interactive Session: How to implement a comprehensible Change Control System in your Company
EU Variation Procedure
Change Control Handbook
Change Control Protocol
with practical advice how to implement and use them

Interactive exercises to examine and evaluate some real examples of various changes:
Manufacturing process
Cleaning process
Analytical process
Microbiological testing
Manufacturer’s Authorisation

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