Dr Rainer Gnibl, GMP Inspectorate, Germany
Dr Hiltrud Horn, Horn Pharmaceutical Consulting, Germany
Aidan Madden, FivePharma, Ireland
Dr Martin Melzer, gempex, Germany
During this Live Online Training, you will learn all relevant aspects to implement and/ or improve your Change Control System fulfilling regulatory and GMP requirements. You will get to know the whole process from initiation over implementation to regulatory submissions. You will also have the possibility to discuss practical examples during several Q&A sessions.
Change Control systems should be an integral part of the quality management system (QMS) 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, questions 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 a quality function 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.
Particularly noteworthy is the adoption of the new ICH Q12 Guideline “Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management”, which was finalised in Singapore by the ICH Q12 Working Group in November 2019. This guideline aims to promote innovation and continual improvement, and strengthen quality assurance and reliable supply of product, including proactive planning of global supply chain adjustments
This Live Online Training 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 Regulatory Affairs.
For our webinars, we use Cisco WebEx, one of the leading suppliers of online meetings. At http://www.webex.com/test-meeting.html you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in. Please just enter your name and email address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.
09.00 - 09.15 h Welcome/Introduction
09.15 - 10.15 h
Change Control - Inspectors Expectations for GMP Compliance
- Essentials for SOP on Change Control
- Internal & external Changes
- PQS Interfaces
- EU requirements
- Change in Quality-Culture?
10.15 - 12.00 h (includes Coffee Break from 10.45 - 11.00 h)
Change Control Management; General Points to Consider: How to manage it, who‘s involved and when does it apply
- Identification and classification of changes
- Risk and impact analysis of changes
- Change control as management tool
- Management of changes with suppliers and contractors
12.00 - 12.30 h
Q&A Session 1
12.30 - 13.30 h Lunch Break
13.30 - 15.30 h
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
15.30 - 15.45 h Coffee Break
15.45 - 16.45 h
Change Control in the context of Product Lifecycle Management:
- Product Development Strategies and Change Control
- Post Approval Change Management/ Comparability Protocols / Established Conditions (ECs)
- ICH Q 12 Product Lifecycle Management
16.45 - 17.15 h
Q&A Session 2
08.30 - 09.15 h
09.15 - 10.15 h
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)
10.15 - 10.30 h Coffee Break
10.30 - 11.30 h
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
11.30 - 12.15 h
Case Studies/Examples of various changes:
- Manufacturing process
- Cleaning process
- Analytical process
- Microbiological testing
- Manufacturer’s Authorisation
12.15 - 13.00 h
Q&A Session 3
List of examples:
As a delegate you will get a comprehensive list of examples for Variations.