Application of new technology from a GAMP perspective

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1 INVITATION ISPE GAMP Nordic Conference Application of new technology from a GAMP perspective Copenhagen 20 March 2014 at 09:00-16:30 The venue will be held at Novo Nordisk s new Domicile Building NN-1, Krogshojvej 48, Bagsvaerd, Denmark:

2 What is it all about? The strongly regulated environment of the pharmaceutical industry poses major challenges for the enterprises in this sector. Each additional day on the way to the approval and launch of a drug or medicine involves high costs. In spite of enormous time and efficiency pressure a consistently high product quality must be ensured. National and global regulations must be complied with and approvalrelevant documentation obligations met vis-à-vis the competent authorities. The pharmaceutical industry is also challenged with outsourcing of data and integrating business solutions in a more and more complex environment. Solutions as cloud poses a high risk if not handled correct and furthermore makes testing more complicated. In order to guarantee this, transparent, intelligent and streamlined validation and qualification processes are required in all stages of engineering and operation. The presentations will guide you through specification, testing and validation with use of cases and relevant experience from our panel of experienced speakers. Material from the conference will be sent out after the conference per , including the article from Pharmaceutical Engineering: Cloud Computing in a GxP Enviroment: The Promise, the Reality and the Path to Clarity Who should attend? Process Engineers, Automation engineers, Quality Engineers and Project Managers, working with the subjects.

3 AGENDA Time Subject Speaker 09:00 10:00 Registration with coffee and breakfast sandwich Networking 10:00 10:20 Welcome and Opening Peter W. Christensen, Novo Nordisk Chairman GAMP Nordic 10: Security and Assurance in the Cloud Data integrity protection of data Torben Voigt Olsen, Lundbeck 11:00 11:45 SAP test Case from China Leif Poulsen, NNE Pharmaplan 11:45 12:30 Lunch Networking 12:30 13:15 Master Data Management Case from NovoZymes 13:15 14:00 Meeting Future Challenges for Pharmaceutical Plants Today! Claus Møldrup, Novozymes Kirstin Rolver + Thomas Anderson, Siemens 14:00 14:20 Coffee break Networking 14:20 15:10 System integration or How I Learned to Stop Worrying and love IT. 15:10 15:55 GAMP SIG Presentation and Work on GxP and Cloud Solutions Kim Kiehn, i2r Anders Vidstrup, NNIT 15:55 16:10 What is Going On in the GAMP community 16:10 16:30 Summary & Closing Comments Anders Brummerstedt, CPIP/ Chairman of ISPE Nordic Peter Werner Christensen Chairman GAMP Nordic

4 Torben Voigt Olsen (CISA, CISM, CISSP) Information Security Specialist, H. Lundbeck A/S, Denmark Torben has more than 10 years of experience with IT and information security. Before joining Lundbeck in 2011 he spent 7 years as a security consultant focusing on security policies, network security and risk assessments. Since joining Lundbeck as an Information Security Specialist in the Corporate Information Security Section he has been involved in number of IT projects involving cloud services and mobile devices. Torben is a member of ISACA and (ISC) 2. Kim Kiehn Senior Consultant at i2r Ost, Electrical Engineer with a broad knowledge of equipment, processes and IT systems in the pharmaceutical industry. He has end user experience from various IT projects, upgrades and new solutions as an employ in Novo Nordisk, and through consultancy work in projects with different level of complexity. Kirstin Rolver joined Siemens a little over two years ago as the Nordic Manager focusing on the Pharmaceutical Industry. During her long career in the IT industry she has negotiated deals with pharmaceutical companies like AZ, Pfizer, Leo Pharma. Her focus is on bridging the gap between business and technical disciplines, gaining business value from the utilization of tools and solutions and maximizing benefits by making data work. Anders Vidstrup is Senior IT Quality SME at NNIT with quality aspects of Computer Related Systems. Over the last 11 years he has been involved in qualification of PCS systems in a large plant for API-production and Factor VII facility (Facility of the Year). He works with principles for qualification of spreadsheets and has had the overall QA responsibility for the infrastructure in Novo Nordisk A/S include handling of security patches and qualify infrastructure components. In GAMP he is a part of the SIG group Testing of GxP Critical Systems. For the new GAMP5 provide input, e.g. the test appendix. He is a part of the SIG related to Infrastructure and Cloud Solutions Leif Poulsen, Senior Specialist, PhD, Automation & IT, NNE Pharmaplan Leif holds a Masters and PhD degrees within Process Engineering and is certified as a professional Enterprise Architect according to the TOGAF 9 standards. At NNE Pharmaplan, Leif is responsible for development of technology, methods and competences within Automation & IT and work as a senior business consultant for customers worldwide. He is an expert on business analysis and conceptual design of Automation and IT solutions including how to deploy such solutions effectively in a GxP regulated organization. Leif is member of the ISA SP88 Batch Control Committee, the ISA SP95 Enterprise Control System Integration Committee and the GAMP Forum (ISPE). Thomas Anderson has a M.Sc. in Electrical Engineering and has worked as an engineer, project manger as well as a department manager delivering engineering solutions to regulated industries such as nuclear, energy and Pharmaceutical. He previously worked for Pharmadule, ABB, Vattenfall, and PlantVision. His industry knowledge and cross discipline approach is instrumental in assisting customers exploiting the use of tools and solutions.

5 Anders Brummerstedt, CPIP and Chair of ISPE NORDIC, has 28 years of experience within engineering and management of projects and people in diverse technical fields. He joined Novo Nordisk in 1996, and has since then worked primarily with quality issues and the use of computer systems and automation in pharmaceutical production. He is currently a Senior Project Manager and Specialist with PEC in Denmark. Throughout his career Anders has worked with many of the primary production processes spanning from API to finished pharmaceuticals, medical devices and quality. Prior to his work in the Novo Group, Anders was a project and line manager working with IT systems in various businesses. Anders holds a Master of Science in Engineering (1986) from the Technical University of Denmark and a Graduate Diploma (Bachelor) in Business Administration from Copenhagen Business School (1992). Anders earned his CPIP in Peter Werner Christensen, Chair of ISPE GAMP NORDIC has an intense personal desire for true quality and value adding activities. He has a solid experience in strategic management and persistent to create results in combination with a deep knowledge and experience with true leadership and culture changes. He has an in-depth knowledge and understanding of the whole pharmaceutical industry from the recent 13 years in Novo Nordisk and know the challenges for value adding activities within all pharmaceutical engineering areas. Peter has international experience through project execution and actively intense volunteer committee work within relevant areas, i.e. ISPE and GAMP, and is often invited to speak internationally within the field of Pharmaceutical Engineering, with lectures given around the world, including China, US and Europe.

6 Registration: Event: Application of New Technology from a GAMP Perspective Date: 20 March 2014, 09:00 16:30 Location: Novo Nordisk, Bygn NN1, Krogshojvej Bagsvaerd, Copenhagen Please register at: before 7th March 2014 Seminar fee ISPE Member Non Member Industry 380/DKK /DKK *) Academia/Regulatory/ 110/DKK /DKK *) Young Professionals 110/DKK /DKK *) Students 75/DKK /DKK 750 *) Table Top Exhibition 500/DKK 3750 **) 500/DKK 3750 **) *) Includes a one year membership in ISPE with all membership benefits please visit ispe.org **) Participation in seminar not included The number of participants is limited. Seats are allocated on a first come, first served principal. For questions on registration please contact: B.O. Conference Service, Bengt Österlund; or Questions regarding the event can be raised to: Peter Werner Christensen:

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