Quality Risk Management & Process Validation in the Product Life Cycle

28 September 2016

Link the science and quality risk-based approach to the global quality system, monitor continuously quality and data integrity to stay compliant and consistently deliver required quality.

This marcus evans conference will help delegates implementing a quality risk management approach into their existing quality systems, understanding how to assess and evaluate risks in their companies and with their Third party partners. They will also gain insights from various companies with the development of continuous process verification, approaching the management of data and preventing potential pitfalls in its implementation.

"Meet Expectations of New FDA and Revised EU GMP Annex 15 on Process Validation To Assure Excellence in Quality"

Keynote Presentation

From Change Request to Change Implementation

During a product’s lifecycle, many changes might occur in the production, labeling (usage) and quality of the drug. For every change the impact on quality, safety and efficacy needs to be evaluated. This requires a change control process. Change control processes are complex and require standards and systems for tracking and tracing changes in development and applied. This presentation is to clarify dependencies and how it can be facilitated by proper functionality of tools.


  • Multi-disciplinary activities
  • Transparency and conformity
  • Process standards and semantics

Speaker: Hans van Bruggen, Senior Regulatory Affairs Scientist - eCTDconsultancy B.V. The Netherlands on behalf of Amplexor Life Sciences

Key Topics

  • Discuss regulatory expectation on quality compliance approaches
  • Define an efficient QRM system and tools across global quality system
  • Design efficient process to assure quality control
  • Correctly handle third-party within QRM processes
  • Apply efficient continuous process verification to monitor the system


Novotel Berlin Am Tiergarten
Str. des 17. Juni 106-108
10623 Berlin