GMP Education Course

Case studies from      

Boehringer Ingelheim Merck Serono Schott Johnson & Johnson Vetter Baxter

Process Excellence and Six Sigma in the Pharmaceutical Industry With Pre-Course Workshop 9-10 December 2008, Vienna, Austria SPEAKERS: Andreas Birnstiel Baxter, Austria Michael Götzke Vetter Pharma-Fertigung, Germany Dr Alexander Huber Schott Schweiz, Switzerland Marco Lupo Johnson & Johnson, Italy Dr Heiko Rengel Boehringer Ingelheim Pharma, Germany Rolf Staal Process Robustness Network, Germany Dr Sven Wedemeyer Merck, Germany

ECA E UROPEAN COMPLIANCE ACADEMY

IMPORTANT / Change of venue This event will take place in the The Imperial Riding School, A Renaissance Hotel Ungargasse 60 1030 Vienna, Austria Tel +43 1 51518 53, Fax +43 1 51518 6722

HIGHLIGHTS:  Business Process Excellence  Lean and Six Sigma in Technical Operations  Process Improvement  Process Capability and Flawless Execution  Statistical Process Control – a Key Tool for Continuous Validation  Six Sigma and Setting Times  Six Sigma and Analytics

Process Excellence and Six Sigma in the Pharmaceutical Industry 9 - 10 December 2008, Vienna, Austria

Objectives

Programme / Case Studies

This course will give you an overview about the adoption of Six Sigma within the scope of Process Excellence.

Business Process Excellence in the Pharmaceutical Industry – Methodologies and Critical Factors for Success  Balanced Scorecard – Definition and Implementation of strategic targets  Optimization of decision making processes  Lean Production – optimization of the pharmaceutical supply chain  Successful implementation of the BPE initiative – critical factors Dr Heiko Rengel

We were able to win leading experts from renowned pharmaceutical companies who will also illustrate the successful Process Excellence and Six Sigma implementation with case studies. A pre-course workshop will  introduce you to Six Sigma basics and  allow you to train Six Sigma tools. Background When the FDA introduced “cGMP for the 21st century” it also gave the concept of Process Excellence a new significance. The authority recognised that process knowledge in the pharmaceutical industry is in parts much different from other industries. That’s where Six Sigma can contribute to improvements. The concept combines the use of statistical methods with a consequent and structured project management for accomplishing error-free processes and maximum business success. Due to this economic background this concept is also interesting for executive management. In addition to Six Sigma the industry also increasingly employs techniques like Designof-Experiments (DoE) and Statistical Process Control (SPC). Following the same goal – to encourage the industry to get to know their processes better and thus manage them more efficiently – the FDA also started the initiative Process Analytical Technology (PAT) in the course of its new orientation. In the meantime this initiative has also been adopted by the EMEA. Target Group This course targets all persons in pharmaceutical companies who want to get involved in Process Excellence and Six Sigma and who are interested in its practical implementation and in techniques which increase efficiency. Moderator Rolf Staal, Process Robustness Network

Case Study Merck Serono The challenge to deploy Lean & Six Sigma in India or Indonesia  Steering a Lean & Six Sigma program for sites on four continents  Balancing the needs between regional and global sites Dr Sven Wedemeyer Case study GPSG-J&J: Process Capability and Flawless Execution  Understanding processes and managing complexity by advanced methods  Application of advanced methods for process design/ control and for process improvement, and related risk management  Process design/control case study  Process improvement case study Marco Lupo Statistical Process Control - a Key Tool for Continuous Validation  What is SPC  How and where can SPC be implemented in the field of GMP  What tools are helpful  What is Process Robustness  How can you use control charts for early warnings and for monitoring  What is the benefit of SPC (also due to savings) Rolf Staal Case Study Vetter Lean and the Reduction of Setting Times  Analyse techniques of setting times  Involving the concerned employees in designing their new process  Implementation of a new set up strategy Michael Götzke

Case Study Schott Involving People in Process Improvement – The Most Important Factor  What are the major cultural and financial benefits  The change in commitment and involvement of employees  Case Study Schott: Involving people in creating and implementing business process excellence programmes Dr Alexander Huber Case Study Baxter Six Sigma and Analytics – Requirements, Application, Benefits and Examples  The Role of Analytics in Process Optimization - Contribution of Analytical Methods for the Total Process Variation  Six Sigma Tools for the Optimization of Analytical Methods  Application of the DMAIC Process and Six Sigma Tools in Technical Problem Solving Projects Andreas Birnstiel Pre-Course Workshop on 9 December Six Sigma in the Pharmaceutical Industry During this pre-course workshop Six Sigma will be explained and discussed in detail. The sequence for improvement DMAIC, the organisation, the roles, the risks and success factors will be covered and discussed with the participants: Six Sigma – What´s that?  Six Sigma – what it is  DMAIC the sequence for improvement  Six Sigma Infrastructure in small and large organizations  The roles and responsibilities of CEOs, plant managers, process owners  The training aspects for Black Belts, Management, champions,  Master Black Belt  Black Belt  Green Belt  Six Sigma Tools  Customization for and aspects of the participants Rolf Staal, Process Robustness Network, former head of Industrial Excellence Aventis

Speakers Andreas Birnstiel Baxter AG, Austria

Andreas Birnstiel is SixSigma BlackBelt and LEAN Instructor at Baxter BioScience, Vienna, a manufacturer of protein based pharmaceuticals and vaccines. Before changing his profession into the direction of coaching and leading improvement projects, he gained more than 5 years experience as manager of different quality control units at Baxter. He started his career in the area of environmental analytics at Merck KGaA in Darmstadt, Germany.

Michael Götzke Vetter Pharma-Fertigungs GmbH & Co. KG, Ravensburg, Germany

Michael Götzke finalised his studies of Mechanical Engineering in 1985 with the degree Dipl. Ing. (FH). He started his career in the automotive industry holding several positions. Amongst others he was responsible for the implementation of a continuous improvement process. In 1993 he became a consultant advising the pharmaceutical, chemical, automotive and semiconductor industries. He joined Vetter Pharma Fertigung GmbH & Co. KG in 2003 as Head of Process Support and Member of the Core Team for the implementation of Six Sigma at Vetter. Since 2006 he is a Master Black Belt and responsible for the Permanent Process Optimization (PPO) Programme.

Dr Alexander Huber, MBA Schott Schweiz AG, St Gallen, Switzerland

Alexander Huber holds a diploma in Biotechnology from the Swiss National Institute of Technology (ETH), Zürich and a PhD in molecular neuropharmacology from the same institution. He also did a part time MBA at the ETH. He started his career in the pharmaceutical industry as a postdoctoral fellow in the research department of F. Hoffmann-La Roche Ltd in Basel, Switzerland in 2002. He changed into a performance management position at the parenteral production department in 2003 where he was responsible for all kinds of GMP compliant process optimizations and risk management. From 2006 until October 2007 he is plant manager for lyophilized products in the same department. In October 2007 he changes to a new position as Head of Production, sterile syringes at Schott Switzerland Ltd.

Marco Lupo GPSG, Johnson & Johnson, Italy

Marco Lupo holds a Master Degree in Chemical Engineering, and achieved the Johnson&Johnson Master Black Belt certification in 2006, after five years experience in Engineering and Improvement Methodologies (Six Sigma, Design of Excellence, Lean), in Medical Device and Pharmaceutical manufacturing. Since 2007 he is working on advanced improvement methods, first in the Cross-Platform Process Mgmt & Methods Group, GPSG EMEA, and then on Pharmaceutical Technology Services, GTO, GPSG.

Dr Heiko Rengel, MBA Boehringer Ingelheim Pharma GmbH&Co KG, Ingelheim, Germany

After gaining experience in various functions in R&D and Operations, Heiko Rengel is currently responsible project manager of the Business Process Excellence Initiative within the German Manufacturing Pharma Division.

Rolf Staal Process Robustness Network, Niedernhausen, Germany

After 11 years as Process Improving Engineer in the US, Mr. Staal worked as Director Process Excellence at Aventis Pharma AG. He developed a method for measuring and improving process robustness whose index is now used for implementing the strategy. To improve processes he also introduced Six Sigma worldwide. In addition to quality and process improvements this also resulted in a general cultural change and cost savings of 20 Million Euro. Since 2004 Mr Staal works as an independent consultant.

Dr Frank Wedemeyer Merck KGaA, Darmstadt, Germany

Dr Wedemeyer studied Process Engineering at the TU Clausthal and received his PhD from the same university. He joined Merck in 1999 and headed different position (e.g. Assistant Plant Manger in the solids manufacturing department). Dr Wedemeyer started his Black Belt education in 2005. Since that time he is performing Six Sigma projects in solids manufacturing and additionally is involved in the integration of Lean & Six Sigma into Merck Pharma Production.

Social Event in Vienna On Tuesday, 9 December 2008 you are cordially invited to a social event! This will be an excellent opportunity to share your own experiences with colleagues from other companies in a relaxed atmosphere.

Easy Registration Form:  Reservation CONCEPT HEIDELBERG P.O. Box 10 17 64 69007 Heidelberg Germany

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Reservation Form: + 49 6221 84 44 34

Internet: @ e-mail: [email protected]  www.gmp-compliance.org

Date Pre-Course Workshop Tuesday, 9 December 2008, 09.00 – 12.00 h (Registration and coffee 08.30 – 09.00 h) Education Course Tuesday, 9 December 2008, 13.30 – 17.30 h (Registration and coffee 13.00 – 13.30 h) Wednesday, 10 December 2008, 09.00 – 16.30 h Venue IMPORTANT / Change of venue The Imperial Riding School, A Renaissance Hotel This event will Ungargasse 60 take place in the The Imperial 1030 Vienna Riding School, A Renaissance Hotel Ungargasse 60 Austria 1030 Tel +43Vienna, 1 51518 Austria 53 Tel +43 +43 11 51518 51518 6722 53, Fax +43 1 51518 6722 Fax Fees Course only Non-ECA Members € 1,490.- per delegate plus VAT ECA Members € 1,341.- per delegate plus VAT EU GMP Inspectorates € 745.- per delegate plus VAT APIC Members € 1,415.- per delegate plus VAT (does not include ECA membership) Course and Pre-Course Workshop Non-ECA Members € 1,890.- per delegate plus VAT ECA Members € 1,701.- per delegate plus VAT EU GMP Inspectorates € 945.- per delegate plus VAT APIC Members € 1,795.- per delegate plus VAT (does not include ECA membership) The fee is payable in advance after receipt of invoice and includes documentation, dinner on the first day, lunch on the second day (and on the first day for the pre-course workshop participants) and all refreshments. VAT is reclaimable. Conference language The official conference language will be English. Accommodation CONCEPT has reserved a limited number of rooms in the conference hotel. You will receive a room reservation form when you have registered for the course. Please use this form for your room reservation or be sure to mention code “VA 5699 ECA Course” to receive the specially negotiated rate for the duration of your stay. Reservation should be made directly with the hotel not later than 10 November 2008. Early reservation is recommended. Registration Via the attached reservation form, by e-mail or by fax message. Or you register online at www.gmp-compliance.org.

Organisation and Contact CONCEPT HEIDELBERG P.O. Box 10 17 64 D-69007 Heidelberg Germany Phone +49 (0) 62 21/84 44-0 Fax +49 (0) 62 21/84 44 34 E-mail: [email protected] www.concept-heidelberg.de For questions regarding content: Sven Pommeranz (Operations Director) at +49-62 21 / 84 44 47, or per e-mail at [email protected]. For questions regarding reservation, hotel, organisation etc.: Ms Susanne Ludwig (Organisation Manager) at +49-62 21 / 84 44 44, or per e-mail at [email protected]. What Is ECA? The European Compliance Academy (ECA) is an independent educational organisation chaired by a Scientific Advisory Board with members of the pharmaceutical industry and regulatory authorities. The ECA will provide support to the Pharmaceutical Industry and Regulators to promote the move towards a harmonised set of GMP and regulatory guidelines by providing information and interpretation of new or updated guidances. What Are the Benefits of ECA? First benefit: During the membership, you enjoy a 10 % discount on the regular participation fee of any European Conference organised by ECA in cooperation with CONCEPT HEIDELBERG. Second benefit: The GMP Guideline Manager Software with a large number of guidelines, e.g. EC Directives, FDA Guidelines, ICH Guidelines, will be forwarded to you when you are using your membership for a conference registration. How Do You Become a Member of ECA? By participating in one of the European Compliance Conferences or Courses marked with ECA, you will automatically become a member of ECA for two years – free of charge. Conferences and Education Courses organised by ECA will be realised in co-operation with CONCEPT HEIDELBERG. More information about ECA can be obtained on the Website http:// www.gmp-compliance.org

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D-69007 Heidelberg GERMANY



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Process Excellence and Six Sigma in the Pharmaceutical Industry 9-10 December 2008, Vienna, Austria

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