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8-9 October 2019

Speakers


Dr Rainer Gnibl, GMP-Inspectorate, Germany

Dr Hiltrud Horn, Horn Pharmaceutical Consulting, Germany

Aidan Madden, FivePharma, Ireland

Dr Martin Melzer, Chemgineering, Germany



Learning Objectives


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.

Background


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.

Programme


Change Control - Inspectors Expectations for GMP Compliance
  • Essentials for SOP on Change Control
  • Internal & external Changes
  • PQS Interfaces
  • EU requirements
  • Change in Quality-Culture?
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)
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
Interactive Session: 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

List of examples:
As a delegate you will get a comprehensive list of examples for Variations.

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
Change Control in the context of Product Lifecycle Management
  • Product Development Strategies and Change Control
  • Post Approval Change Management/ Comparability Protocols
  • ICH Q 12 Product Lifecycle Management
Workshops: Interactive exercises to examine and evaluate some real examples of various changes:
  • Manufacturing process
  • Cleaning process
  • Analytical process
  • Microbiological testing
  • IMPD
Manufacturer’s Authorisation