12 - 13 February, 2019 | Meliá, Berlin, Germany

Jan Van Moll


Director of Quality and Regulatory
Philips


1:00 PM Ensure Product Quality by Implementing Effective Root Cause Analysis Techniques

Bad product quality can haunt companies long after release. Root cause analysis (RCA) on product quality issues is an indispensable step to avoid and prevent these from recurring. Unfortunately the medical device industry is struggling to conduct successful RCA both on product products as well as process issues. Though being crucial to processes like CAPAs, companies fail to unlock the full potential of RCA techniques by limiting themselves to the usage of ‘quick and easy’ techniques only. This workshop session is aimed at providing the primary training necessary to produce adequate problem statements, and demonstrate the power of several successful, but rarely used RCA techniques. This interactive workshop will challenge the participant to re-evaluate their RCA approaches in their own domain by completing hands-on group exercises, complimented with real-life RCA case studies from the regulated device industries.
 
Session Objectives:
  • Apply successful RCA tools and write effective problem statements by taking part in interactive group activities
  • Understand the importance of adequate problem statements to RCA
  • Gain hands-on experience writing effective problem statements
  • Boost your product quality by applying powerful RCA techniques
  • Explore the importance of proper RCA with respect to CAPA and successful problem solving

4:25 PM Recognise Factors that Influence the Introduction and Non-Detection of Software Defects

  • Identify the factors that influence the introduction and non-detection of software defects by hearing real-life case studies
  • Don’t waste time: gather insights on how to prevent and efficiently detect defects in your software
  • Utilise potential solutions with proven success in enduring device quality and reliability


Check out the incredible speaker line-up to see who will be joining Jan.

Download The Latest Agenda