Education Session

201 - LEAN Quality: Applying Lean Thinking to Quality Systems & a Case Study: LEAN within Quality Assurance/Quality Control at H. Lundbeck A/S

Get Agenda 9 November 13.30-17.00
ISPE CEUs: 0.25

Tracks: SurvivalProductQuality

This session will present a practical Lean Approach to Quality Systems. This process will examine value-added activities versus waste and overall flow activities. Concepts and examples of successful implementations that have enhanced the compliance of Batch Records, Deviations, Change Controls and OOS will be presented.

This session will also describe a case study of the transformation of H.Lundbeck A/S, QA/QC organization from traditional GMP/quality group to a high performance team within the supply operations. We will discuss how, why, and what was done as well as the benefits of these actions to date. After the presentation we will devote time for a question and answer, and interactive discussion with participants. Topics will include:

  • Understand an approach to apply Lean Thinking to Quality Systems
  • Cultural change and technical solutions
  • Results achieved and how we practice LEAN today
  • Suggestions for how to get started with lean in your QA/QC department

How you will Benefit

At the end of this session, participants will be able to:

  • Understand one way to successfully implement LEAN in administrative and laboratory environments, transforming into a high performance team
  • Address the culture change that this type of transformation brings about
  • Involve and motivate employees in the transition
  • List possible technical solutions
  • Outline savings that can be realized by this change

Who Should Attend

Vice presidents, divisional directors, department heads, and key people working with LEAN and QA/QC

ISPE Communities of Practice (COPs)

C&Q and GCLP

View the ISPE Community of Practice (COP) Guide

Session Leader

  • Grace Chin, Senior VP, BioPharmaceuticals, SNC-Lavalin Pharma Canada

Session Presenters

  • Lene Andersen, Divisional Director, H Lundbeck A/S Denmark
  • Julie-Lea Lipszyc, Compliance & Quality Director, SNC-Lavalin Pharma Canada
  • Mikael Rasmussen, Head of Department, H. Lundbeck A/S Denmark

Annual Meeting Sponsors