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DAY 1, 1 December 2014


Nurturing a high-performance culture: the critical contribution and stability of senior talent

Helen is a key contributor in the success of Lake Region Medical guiding them towards becoming a bronze SHINGO prize winning company

  • Creating a dynamic company - actively encouraging individuals and giving support to apply knowledge in a smarter way and to come up with creative, well-reasoned solutions
  • Attracting the best talent - appealing to a work-force from over 30 different countries
  • Implementing high potential and talent management programmes - develop and grow the most promising management of the future

Helen Barry
HR Director
Lake Region Medical


Launch of Operational Excellence program in March 2014

Frédéric has been a board member for the Swiss Society of Industrial Pharmacists since May 2013, representing the industrial pharmacists as well as supporting and awarding outstanding work in the industry

  • Top down approach with first step: Training (of 80% of Site staff); 8 waste and 5 S deployement
  • Implementation of Visual management on shop floor and Set a management Cockpit across function
  • Value stream Map analysis- identification of main saving potential
  • Set KPI and launch Action plan on main potential saving
  • Track and report saving (reduction of deviation, Improvement of documentation quality; reduction of Throughput Time)

Frédéric Zwahlen
Vice President Supply Chain
Vifor SA

process & performance improvement

Eliminating the end-product batch sterility test of parenteral products and other pharmaceutical dosage forms through filing process assurance

  • Reducing quality assessment to one day to ship product immediately through validation processes
  • Designing quality into the product, monitoring the manufacturing processes, and controlling the quality of intermediates and finished products in real-time to reduce timelines
  • Incorporating PAT into these stages for real-time release of pharmaceutical dosage forms, by preventing the need for end-product batch testing
  • Advancing PAT technology to monitor manufacturing to enable quality control of the intermediates and finished products, allowing for their release in real-time

Guenaelle Piou
Lean Coach

regulatory compliance

Updating systems efficiently with assurances throughout the lifecycle of the product

Michael is the lead for the review and improvement of the Medicine Authority's document storage system and facilities project which contributed to them achieving ISO 9001 certification

  • Breaking the tradition - how to get regulators on board when replacing testing with improved equipment
  • What exactly the regulator wants to see in order to pass the audit first time round
  • Exploring the future of audits from ‘tick-box’ to other measures of effectiveness that ensure quality control and satisfy regulatory demands


Michael Chetcuti
Quality Assessor
Malta Medicines Authority

engineering, facilities & technology

Maintaining exacting particulate levels through validation to ensure quality of product

Matthew has had several publications to his credit in international journals such as the flagship EMBO journal in 2002 to The Journal of Biological Chemistry in 2007, showcasing his compelling research

  • Ensuring clean room is sealed correctly and pressurised properly using the latest technological advances
  • Guaranteeing air quality through in-situ moulded air-ducts to ensure low-particulate levels
  • Validating clean rooms with computer systems meeting the CFR 21 Part 11 to meet the FDA’s accepted data formats and ensure maintenance throughout life of room

Matthew Sanders
Director, Process Architecture Improvement

supply chain integration

Building transparency and traceability into the global supply chain by breaking down silos to reduce costs and improve customer service



  • Incorporating operational excellence into the supply chain from API production or procurement to customer delivery to shorten timelines
  • Optimising costs by synchronising the supply chain and logistical network to create an integrated, all-encompassing manufacturing system
  • Creating a lean supply chain to drive out waste and improve efficiency, to not only reduce costs, but also improve flexibility and productivity to enhance customer and brand satisfaction

Prashant Yadav
William Davidson Institute, Faculty, Ross School of Business, School of Public Health, U-Mich




Gain total control over your extended supply chain through integrated messaging, applications, and data analytics across your network of collaborating and trading partners

  • Frictionless Commerce – Share information and transact seamlessly across your global trading partner network
  • Clear Visibility – Answer key questions; “where are my materials?”, “was my booking confirmed?”,  “when did the product arrive at customer?”
  • Market Driven – Build outside-in flexibility supply that quickly responds to external drivers and disparate demands
  • ERP Agnostic – Get unstuck – a ‘Come-As-You-Are’ approach removes traditional integration and collaboration  barriers
  • Highly Scalable and Secure – Powered by latest generation Infrastructure and Platform as a Service technologies (IaaS and PaaS).  The ‘Network Effect’ maximizes benefits and accelerates value from key supply chain functions


Robert Nientker
Senior Sales Executive

process & performance improvement

Integrating Lean and Six Sigma into all aspects of daily activities to improve efficiency by altering description emphasis

Deirdre has played a pivotal role in ensuring the successful implementation of APEX (Amgen Process Excellence) regime which is now being rolled out across other sites to replicate this process improvement globally

  • Transforming a programme to a culture by amending wording to reflect the day-in, day-out efficient routine
  • Re-branding improvement programmes as need-based systems where a lacking is identified and tools deployed in the most efficient manner
  • Developing a work-force that are capable of acting proficiently, using Lean and Six Sigma, but are unaware of this complete integration

Deirdre Cooney
Director Operational Excellence

regulatory compliance

Achieving incorporated QbD principles through a combination of innovative, robust process analytics, model-predictive control and flexible automation

Dr Bhoop has earned over 203 publications during his career and his renowned works have been cited over 2200 times

  • Fully engaging with IT stakeholders and data quality from the offset as full QbD starts from a comprehensive control strategy of raw materials and cell banks
  • Reducing timelines through an integrated centralised data management concept so drugs pass through the FDA filing processes significantly faster
  • Understanding the business case for a QbD drug – examining the longer term financial savings

Dr Bhupinder Singh Bhoop
Dean Faculty of Pharmaceutical Sciences
Education Institution

engineering, facilities & technology

Taking a risk-based approach to cross-contamination by overcoming the technological equipment challenges to manufacture without product exposure and meet the new EU GMP Chapters 3 and 5 guidelines

Xellia Logo

  • Preventing API cross-contamination in finished products through specialised air handling equipment and processing equipment that ensure required exposure control by identifying reliable suppliers
  • Overcoming and determining process risk through process proximity analysis and separating manufacturing areas into zones assigned a colour and number to allow for easy identification
  • Identifying the greatest potential source of containment by measuring manufacturing scale, frequency of production and dosing regime on a regular basis to reduce risk of cross-contamination
  • Developing a successful and robust cleaning validation programme from raw materials to final product flow to prevent contamination and pass audits

supply chain integration

Optimising complexity in supply chain decisions by implementing complex adaptive system (CAS) modelling to counteract the increasing product pipeline


  • Quantifying supply chain complexity to stop reacting intuitively and develop tools and methods in order to make complexity-optimised decisions
  • Interpreting the supply chain as a CAS, with a large number of interacting and evolving agents who adapt and learn, in order to solve complexity dilemmas
  • Creating a forecasting-improvement initiative to tie timings and frequency to decision needs to reduce costs by up to 10%

Marcel De Grutter
Business Technology Head Operation/QC - Established Pharmaceutical Division IT
Abbott Laboratories
The Netherlands


How Lundbeck encouraged and inspired the organisation and gradually transformed it to a Lean culture 

Christian has helped drive Lundbeck towards winning a SHINGO silver medallion with his lean transformation initiative

  • How leadership development was utilised to build the Lean culture and the right leadership behaviour
  • How Lundbeck drive the principles of operational excellence in to the organisation and the minds and harts of the employees
  • Lundbeck was recognized with a SHINGO Silver Medallion in 2012 as the first European company and the first pharmaceutical company globally.

Christian Houborg
Vice President, Service and Technical Operations and Lean


DAY 2, 2 December 2014


Breakfast Briefing


Predicting the regulatory landscape over the next five years

Dr Chidwick is a key advisory committee member at the European Medicines Agency (EMEA) for guideline drafting and for the European Directorate for the Quality of Medicines (EDQM)

  • Will the trend for increasing regulations continue despite rising costs?
  • Overcoming the challenges of rising costs and increased regulations to remain competitive
  • Developing a robust communication strategy between pharma companies and regulatory bodies

Dr Keith Chidwick
Pharmaceutical Assessor

keynote-think tank

Uniting management mind-sets for external success by taking a holistic approach to business

(An interactive panel discussion focusing on thought provoking challenges being led by the speaker. Opportunity to have the audience involved by posing challenges or tasks to be completed as a group)

  • Streamlining the organisational structure and therefore management structure to maximise organisational effectiveness
  • Revolutionising operational planning, development and implementation for higher investment return
  • Developing a world-class manufacturing process by re-strategising management for flexibility and responsiveness

Carsten Thorngreen
Director, Pre-Assembly Production in Device Manufacturing & Sourcing
Novo Nordisk

Morten Søvndahl Johannessen
Lean Partner, Pre-Assembly Production in Device Manufacturing & Sourcing
Novo Nordisk

Tim Schwarting
Program/Project Manager, Device Manufacturing & Development, LSS Black Belt
Novo Nordisk

process & performance improvement

Building a culture of continuous improvement by rethinking operational excellence as an incremental, every-day, every-person process for incremental improvements at every stage

Victor’s formidable leadership qualities has enabled him to transform company culture to create thriving businesses

  • Creating sustainable improvement by increasing collaboration and partnerships between operations and quality to build a quality assurance presence on the shop floor, ensuring compliance
  • Visualising flow of Gemba walk to employees for identification of normal and abnormal flow to increase right-first-time performance in batch records
  • Up-skilling shop floor personnel in their understanding and performance of cGMP/compliance through coaching and mentoring so QA personnel and operations staff work as partners

Victor Torres
Global Engineering Director

regulatory compliance

Improving business and manufacturing performance by incorporating Six Sigma, Lean and Kaizen from the initial facility design

  • Using Six Sigma as a data-centred process improvement strategy to build quality into processes to avoid complications
  • Transforming ‘good’ product quality of 3.5 sigma to ‘virtual perfection’ of 5.5 sigma by incorporating Lean as a fundamental strategy, not an added programme
  • Utilising Kaizen to accelerate growth and reduce costs by quickly implementing and making changes to specific processes with defects

Inna Ben-anat
Director, Global QbD Strategy and Product Robustness

engineering, facilities & technology

A step-by-step guide to ensure that procured equipment meets qualifications and regulatory demands

  • Developing a Supplier Quality Standard Agreement to outline requirements from suppliers to ensure defect prevention and the continuous developments of quality into products
  • Specifying the requirements of a comprehensive quality system to ensure the supplier has measurable and accountable quality objectives
  • Outlining expectations on suppliers to develop and maintain a management system to assure consistent conformance of their products to denoted quality and cost requirements

Mike Isles
Executive Director
European Alliance for Access to Safer Medicines

supply chain integration

Developing a complete serialisation programme that incorporates both local and global standards to ensure full supply chain ownership

Erik has proven success in profitability improvement through cost reduction, streamlining business processes and innovation and business-growth strategies

  • Guaranteeing global track and trace compliance for secure access to market growth and product integrity through cloud based network platforms
  • Introducing serialisation into the supply chain right first time by identifying the correct production line equipment supplier with specialised technology and capabilities through adaptability assessments
  • Managing the wide global variation and unpredictability by approaching serialisation requirements as a business strategy that incorporates packaging, IT, brand protection and supply chain operations

Erik Dam
Global Supply Strategies


Identifying facility bottlenecks within production

  • Highlighting the equipment/machinery that is holding back the facility's operations
  • Showcasing any equipment that has excess capacity that can be efficiently utilised



Operational Excellence + Simulations: Bringing Predictive Analysis to Biotech


  • Using Operational Excellence as a starting point for simulations
  • Using real data from your plant historians to build predictive simulations
  • How simulations can help increase throughput by 30% or more with little or no capital investment?
  • Case studies with, and without, a simulation model to show the benefit to manufacturers

panel discussion
process & performance improvement

panel discussion
regulatory compliance

Panellists include:

Ciprian is passionate about optimising process techniques and delivering open innovation strategies throughout the entire supply chain

Ciprian Florea
Global Head, Innovation, TechOps
Novartis Consumer Health

panel discussion
engineering, facilities & technology

process & performance improvement

Creating a trusted, credible and respected organisation through employee surveys and activity programmes

  • Developing strategies that build employee engagement into day-to-day business operations and workplace culture to ensure long-term results
  • Creating employee feedback systems to drive high workplace satisfaction and increase productivity while delivering cost-efficiencies
  • Improving workforce productivity by managing talent and retaining top performers while controlling labour costs through low staff-turnover

Roni Dattani
SixSigma Black Belt Lead
CSL Behring

regulatory compliance

Guaranteeing validation robustness throughout the manufacturing process through a repeatable system to ensure compliancy requirements

Thurloch is a fountain of knowledge in the world of quality management with over 30 years’ experience in the pharmaceutical industry

  • Measuring and evaluating process stability and process capability in order to meet regulatory requirements and guarantee quality
  • Meeting the GAMP guidelines for computer validation and 21 CFR Part 11 for electronic records to ensure integrity and reliability of records
  • Building validation as part of the complete life cycle of a computer system in order to satisfy Annex 11 of the European GMP directive

Thurloch O'Criodain
Global Lead Quality Steward

supply chain integration

Lowering process costs and improving supplier integration through improved efficiency of supply chain management


  • Developing visibility across partners and obtaining efficiencies through end to end process and network optimization
  • Understand main drivers and key challenges during the redesign of complex supply chains
  • Using supply chain as a source of competitive advantage

Murillo Xavier
Strategic Development, Industry Standard Servers (ISS) Supply chain


  • Prioritising team engagement and understanding

Realising that lean in R&D can mimic but cannot not mirror manufacturing principles

Maximising process understanding and mapping to limit waste, time and cost



  • Using new packaging technologies to counteract drug counterfeiting
  • Implementing new technologies to meet anti-counterfeiting regulations


  • Tracking records effectively to execute life science projects
  • Successfully linking process technology and complex facilities to integrate solutions.

process & performance improvement

Reducing variation by 60% and improving average OEE by nearly 20 points within 16 weeks

Carsten has revamped the working structure at Novo Nordisk by increasing the production capacity through the introduction of lean processes

  • Integrating performance management, leadership behaviour development and workforce development with lean principles to improve final assembly performance
  • Reintegration of the Performance Improvement Cycle through bottom-up confirmation and top-down prioritisation
  • Creating value from failure: how to assess an unsuccessful update to gain value from the learning cycle

Carsten Thorngreen
Director, Pre-Assembly Production in Device Manufacturing & Sourcing
Novo Nordisk

Morten Søvndahl Johannessen
Lean Partner, Pre-Assembly Production in Device Manufacturing & Sourcing
Novo Nordisk

Tim Schwarting
Program/Project Manager, Device Manufacturing & Development, LSS Black Belt
Novo Nordisk

engineering, facilities & technology

Ensuring engineering facilities meet the required standards for containment equipment, room cleanliness and perimeter monitoring to reduce risk of cross-contamination

  • Categorising drug substances according to their potency using occupational exposure limits and bands, in order to implement a thorough risk assessment
  • Increasing the efficiency of manufacturing highly-potent APIs to reduce timelines by incorporating the latest engineering technologies
  • Protecting employees and the product through extra containment barriers, including personal protective equipment and proper training on operation and maintenance of isolation equipment

supply chain integration

Managing the product code data centrally to minimise the risk of counterfeiting by ensuring product security electronically, integrating CFR 21 Part 11

Ryan is the 2012 Award winner for Pharma Supply Chain Officer of the Year at 6th Express, Logistics and Supply Chain Conclave (ELSC)

  • Ensuring one product code across the whole life-cycle of the drug internally and externally by managing the data centrally to reduce risks in counterfeiting
  • Improving productivity and efficiency through automation by minimising the maintenance and retention of paper documentation
  • Increasing speed of identification and removal of counterfeit and recalled drugs by implementing a track and trace system using a data matrix

Ryan Viegas
VP supply Chain


DAY 3, 3 December 2014


Driving continuous improvement though the company vision to build a highly engaged and adaptable workforce


  • Integrating VSMs into the CII process to create a scheduled pipeline of products that reduces costs
  • Employing the CII process to map the extended supply chain, from tier two raw material suppliers, through to primary and secondary distribution centres
  • Making the customer central by running a customer connection programme on site

Franck Demarest

keynote-think tank

Assessing the trend for product volume to reduce whilst number of products increases

(An interactive panel discussion focusing on thought provoking challenges being led by the speaker. Opportunity to have the audience involved by posing challenges or tasks to be completed as a group)

  • Addressing the increasing pipeline in order to maintain profitability long-term
  • Balancing the increasing costly quality requirements with decreasing margins
  • Delivering the complexity in the supply chain caused by the change in model

process & performance improvement

Consolidating the right combination of tools to enhance processing systems and deliver high quality products under intense time constraints

AstraZeneca logo

Marcel presently holds an honorary research fellow role in the Pharmacy School at the University of Manchester

  • Deploying effective systems to accelerate drug development processes to support clinical programmes and commercial supply chains in operations under the severe pressures of compressed timelines
  • Exploring the latest advancements in the pharmaceutical development field which have the potential to expedite the delivery of robust products and processes, whilst enabling rapid commercialisation
  • Reviewing examples of innovation in predictive science, automation, process analytical technology and advanced manufacturing technologies with reference to applications in drug development programmes

Marcel de Matas
Principle Scientist Product Design & Innovation

regulatory compliance

Using trending data from in process control and developing the most effective metric systems for quality improvement throughout operations

  • Effectively linking  process data to product quality
  • What is the industry standard for quality key performance indicators?
  • Effectively standardising quality KPIs throughout operations
  • Satisfying regulatory demands by implementing more specifications and testing methods
  • Successfully implementing unique quality concepts during sampling
  • Performing root cause analysis and performing effective trouble shooting

Dr. Gernot Scharf
Head QA
F. Hoffmann-La Roche AG

engineering, facilities & technology

Examining the benefits of Cilag’s System Based Ownership Concept (SBOC), including reduced accidents without a costs and insufficient separate EHS group

  • Interpreting Johnson & Johnson’s Management Action Awareness Reporting System into separate system owners for each EHS aspect, to execute the system across a workforce of 12,000
  • Developing a matrix organisational system so EHS penetrates into the full organisation, spreading responsibility across the shop floor to lower accident rates by x%
  • Incorporating EHS as an aspect of daily jobs, using SBOC, to successfully benchmark results and pass audits

supply chain integration

From planning, evaluation and execution - identifying potentially adverse process issues early to ensure success proactively

Julian Amey is the co-Author of a recent study from January 2011 into Supply Chain Management organisations in the process industries

  • Identifying the correct suppliers to match business needs and integrate vendor into management structure to ensure alignment of long-term objectives
  • Eliminating risk through a mitigation plan that identifies and defines critical process parameters and critical quality attributes

Julian Amey
Principal Fellow & Acting Director of Professional & Executive Programmes, Warwick Manufacturing Group
University of Warwick


Supplier & partner relationship management

  • Efficiently measuring & communicating performance expectations and results
  • Prioritising mutually agreed-upin standards over internal biases
  • Ensuring a heightened understanding of performance & potntial improvements


How can pharma manufacturers meet regulators putative demands amidst price pressures, regulatory changes and healthcare reforms?

  • Understanding the most significant regulatory trends  impacting production
  • Improving statistical data analysis and understanding to prepare for increasingly skilled regulatory questions and deeper technical investigations
  • How are the most successful pharma companies dealing with price pressures, low cost production vs. innovation and total cost reduction of patient treatments?


Understanding the root-causes of equipment stoppages

  • Rebuilding maintenance and production planning
  • Training Operations and Maintenance teams
  • Using the right equipment with the right product using a deep process engineering approach
  • Implementing OEE and its analysis from the beginning

Ensuring streamlining of flow between manufacturing and transportation

  • Effectively planning sales and operations
  • Forecasting demand and planning for this efficiently
  • Using the supplychain software schedule transportation
  • Restructuring the overall operation strategy and key processes

panel discussion
process & performance improvement

panel discussion
regulatory compliance

Panellists include:

Jochen has been directly involved in the new development project at Novartis Vaccines with the opening of the new Marburg site in June 2014

Jochen Reutter
Site Head and Managing Director

panel discussion
engineering, facilities & technology

panel discussion
supply chain integration


What is the future of the use of data and technology in the pharmaceutical industry?

Joaquín is responsible for helping to introduce a supplier management portal on the Decisyon 360 platform helping company procurement managers improve supply chain reliability, quality and reduce risk

  • Shop-floor data metrics – the impact of hand-held devices at the manufacturing stage
  • Connecting patients to the manufacturers in order to assess supply and demand in real-time
  • Exploring the potential impacts this will have on the pharma manufacturing industry

Joaquín Santos Benito
Senior Director External Supply Integration