Change Control

Change control systems are an important part of a quality management system. Professionally implemented, they ensure that all changes are carefully reviewed, fully documented and authorized. Fulfillment of regulatory requirements and compliance with the GMP requirements of the EU or FDA are crucial.

The ECA Academy's live online training "Change Control – News Aspects and Best Practices" on October 6/7, 2020, will cover all relevant aspects for the implementation and improvement of change control systems. The focus will be on the entire change control process and the formal categorization of product-related changes in accordance with regulatory requirements.

Experienced experts address subject matter experts in the areas of production, quality control and quality assurance and offer the opportunity to learn about the practical implementation in case studies...

Product Life-Cycle Management and Guideline ICH Q12 Lifecycle Management will be addressed.

Dr. Martin Melzer, Principal Consultant of gempex GmbH, will support the event on the basis of profound professional competence and broad practical expertise with three lectures and a case study contribution:

  • Change Control Management - General Points to Consider
    How to manage it, who’s involved and when does it apply

  • Change Control in the Context of Product Lifecycle Management
    featuring ICH Q 12

  • Case Studies and Examples
    of various changes

Further information on the program and registration is available on the website of the organizer concept Heidelberg.

If you have any questions about Change Management, Dr. Martin Melzer will be happy to answer them personally. Please contact him via:
info@gempex.com