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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

WHY TO ATTEND

Quality metrics update

Data integrity governance

LEAN
quality

ICH Q3D Elemental Impurities

TAKEAWAYS & SPECIAL FEATURES

  • Implementing effective governance processes for data integrity by Lundbeck and former MHRA inspector

  • Addressing deficiencies in cleaning and cross-contamination effectively

  • Successful preparations for expected Annex 1 revisions

  • Next steps in quality metrics

  • Implementation of ICH Q3D Elemental Impurities requirements by Merck

  • Applying LEAN approach to quality by Roche

  • Managing CMOs and suppliers for greater quality by Eli Lilly

  • Best practices for proactive compliance & risk management by Baxter

  • Examples of process simplification & robustness

  • 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

A Group MBB mentored for years by TPS senseis and specialized in process industries Lean transformations, Enrico is supporting the major European Sites by rolling out Network Throughput Improvements &

Learn more about Enrico >

Aren Avadisyan photo
Turkey flag Turkey

Aren Avadisyan

Site 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 >

Joerg Schlingemann photo
Germany flag Germany

Joerg Schlingemann

Director, Head of Quality CMO at Merck

Mauro Giusti photo
Italy flag Italy

Mauro Giusti

Director, Technical Services/Mfg Science and Mfg Sourcing/Vendor Mngt at Eli Lilly

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 www.baxterbiopharmasolutions.com

CO-LOCATED EVENT

28.-29. September 2017, Hannover

Want to know more?

Who should attend

BY POSITION

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

BY INDUSTRY

  • 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

    Speaker

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

    Kinga Király

    Delegate

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

    Fabrizio Pasqua

    Speaker

Facts from 2016

100 +

Participants

35 +

Speakers

Rating 8.6 / 10

on Event Advisor

Sponsor and Partners

Gold Sponsor

Media Partner

Media Partner

Media Partner

Media Partner

Media Partner

Media Partner

Join us in Hannover

Hanover, situated on the River Leine, is the capital and largest city of the German state of Lower Saxony. It is an important commercial and cultural center with a university, music academies, numerous world-class museums, galleries, and theatres. With events such as Oktoberfest Hanover, one of the largest such celebrations in the world, and Hanover Schützenfest, the world's largest marksmen's gathering, it is also an important trade fair and festival center.