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13th Annual
Quality in Pharma & Biotech
28. September - 29. September 2017, Hannover

Regulators' view on data integrity governance

Baxter's award winning case study in Halle


Data integrity


ICH Q3D Elemental Impurities


  • Implementing effective governance processes for data integrity by Lundbeck

  • Teva's strategy for introducing electronic data review of chromatography data

  • Baxter's approach to constantly improve site audit readiness

  • Roche's strategy for applying a lean production system methodology to a global quality function

  • Implementation of ICH Q3D Elemental Impurities requirements by Merck

  • Combining quality with efficiency & building robustness

  • Tips for managing  supplier's and CMO's quality & reliability

  • Site visit

    to Baxter facility in Halle Westfalen

  • Inspector's perspective

  • Workshop

  • Quality, OPEX and Manufacturing experts

    All under one roof

  • Round-tables

    with CMOs and suppliers

  • Dilemma debate

    lean vs quality

Meet the speakers

Enrico Tavella photo
Austria flag Austria

Enrico Tavella

Pipeline Liaison Quality Lead at Shire

In this role Enrico acts as GMP Clinical QA Liaison Lead for Shire´s internal GMP production sites, supports the harmonization of global clinical products release, drives the implementation of robust

Learn more about Enrico >

Aren Avadisyan photo
Turkey flag Turkey

Aren Avadisyan

Country Quality Head at Sanofi

Aren has over 16 years experience in the pharmaceutical industry, working as Country Quality Head in Sanofi Turkey . His experience includes Distribution, Quality and HSE management, project managemen

Learn more about Aren >

Sean Laffan photo
Ireland flag Ireland

Sean Laffan

Associate Director Global Quality at Teva

Associate Director Global Quality Sean Laffan has an Honours Degree in Applied Chemistry and a MBA, both from Waterford Institute of Technology, Ireland. He started his career as an analyst in Ciba-

Learn more about Sean >

Joerg Schlingemann photo
Germany flag Germany

Joerg Schlingemann

Director, Head of Quality CMO at Merck

Joerg is currently responsible for CMO Quality Management at Merck KgaA in Darmstadt, Germany. He started his professional career as a research scientist at Olink Bioscience in 2005 and later at Q

Learn more about Joerg >

Site visit to Baxter in Halle, Winner of the 2016 Facility of Year Award (FOYA) in the category of Operational Excellence

Baxter’s BioPharma Solutions
business supports leading pharmaceutical companies in meeting their commercialization objectives by providing scientific expertise, sterile manufacturing solutions, parenteral delivery systems and customized support services needed to meet the unique challenges that parenteral products face.

The company’s oncology manufacturing facility expansion in Halle, Germany is a winner of the 2016 Facility of the Year Award (FOYA) in the category of Operational Excellence.

Baxter’s Halle facility team was recognized for undertaking a challenging project to add additional capacity to service the CMO market of parenteral oncology products, while avoiding impact on current operations and customers.

For more information, please visit


28.-29. September 2017, Hannover

Want to know more?

Who should attend


SVPs, VPs, Heads, Directors of:

- Quality assurance

- Quality control

- QPs

- Quality risk management

- Quality compliance

- GMP compliance

- External quality

- Quality & regulatory affairs

- Quality audits

- GMP inspectors

- External manufacturing

- Quality process excellence


  • Pharma & Biotech companies
  • CMOs
  • Suppliers
  • Competent authorities
  • Service & solution providers

What do the attendees say

  • "Very excited after this 1st experience as a speaker. Special interest in Health Authorities inputs and experienced peers."

    Fabien Monjanel


  • "The event was really useful to learn more about the quality requirements, difficulties and solutions in pharma industry."

    Kinga Király


  • "Good overall contribution. Nice presentations and interaction."

    Fabrizio Pasqua


Facts from 2016

100 +


35 +


Rating 8.6 / 10

on Event Advisor

Sponsors and Partners

Gold Sponsor

Gold Sponsor

Gold Sponsor

Media Partner

Media Partner

Media Partner

Media Partner

Media Partner

Join us in Hannover

Radisson Blu Hotel

EXPO Plaza 5

D-30539 Hannover


Tel: +49 (0)511 38383-3500

Visit hotel website.