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.
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
How to handle Changes in US
- European Requirements
- When to contact authorities
- Changes in key personnel
- SMF changes
- Change Control in the light of inspections
The Change Control Process through the Product Life Cycle (Part 1):
- 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)
How to manage it, who’s involved and when does it apply
What’s a Change and how to proceed
- The importance of Change Control
- GMP-compliant Change Control
- General Requirements
- Implementation of Changes
The Change Control Process through the Product Life Cycle (Part 2): Risk Management and Quality Metrics
- Technical changes: Change Control or not
- How to deal with software updates
- Risk Analysis in Change Control
- Classification of Changes
- How to document changes
Interactive Session: How to implement a comprehensible Change Control System in your Company
- The final review and evaluation after implementation
- CC effectiveness check
- Applicable KPIs and Quality Metrics
- 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