Live Online Training: Change Control - New Aspects and Best Practices
6/7 October 2020
Course No. 18313
Speakers
Dr. Martin Melzer
Gempex
Aidan Madden
FivePharma
Dr. Rainer Gnibl
GMP Inspektor, Regierung von Oberbayern
Note: All times mentioned are CEST.
Objectives
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.
Background
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
Target Group
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.
Technical Requirements
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.
09.15 - 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
SOPs
Change Control Protocol
Forms
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
Day 2
08.30 - 09.15 h Case Studies/Examples
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
IMPD
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.
This course is part of the GMP Certification Programme "ECA Certified Quality Assurance Manager" Learn more
This training/webinar cannot be booked. Send us your inquiry by using the following contact form.
To find alternative dates for this training/webinar or similar events please see the complete list of all events.
For many training courses and webinars, there are also recordings you can order and watch any time. Just take a look at the complete list of all recordings.
Testimonials
Seminar Programme as PDF