European Pharma Maintenance Masters » Agenda

Chair & Moderation

Fabio Oro, Principal, Kienbaum Management Consultants GmbH

A systematic approach for achieving operational excellence in the
pharmaceutical industry
Dr. Falk Klar, Chief Compliance Officer, IDT Biologika / Germany

• Analysis of starting point regarding resource allocation, determination of interfaces and document structure
• Good processes as multi-segment targeting combining GMP compliance with efficiency and feasibility
• Participation of operators and process-owners in process analysis and configuration to guarantee adherence
• Seven elements of process management: identification of requirements, evaluation, modelling, adjustment, realisation, optimisation
• Breakdown a systematic approach into maintenance activities

Building a Winning Maintenance Strategy with VDM
Mark Haarman, Managing Partner, Mainnovation

• Learn how a maintenance organization can add economic value to the business
• Understand how the maintenance performance can be measured with KPIs and benchmarks
• Discover the latest best practices in maintenance and asset management
• See how other pharmaceutical companies have established impressive business results using VDM

The application of systems design to the development of the concept for the transformation of a biopharmaceutical production facility for 21st century operation and implications for maintenance activities
Dr. Nicholas J Murrell, Head of Engineering, Lonza Biologics Plc/ UK

• Use of systems design approach reduced concept development
• Approach allows the systematic generation of system and user requirements and the testing of all design elements and concepts
• Use of tools such as Pugh Matrixes and Morphological Boxes ensures no potential solution is neglected
• Inclusive approach allows input from all stakeholders from the shop floor to the management team and ensures buy-in

How to shift from reactive to proactive maintenance in 90 days using lean and Six Sigma techniques with BD medical’s 10 Step TPM methodology
Michael Elliott, Instrument Plant Lean Leader / Operations, BD Diagnostics US

• How to create a TPM system using lean and Six Sigma tools and techniques to identify and overcome lost costs, waste, minor stoppages
• Follow a 10 step approach kicked off with a lean kaizen blitz event
• Improve daily throughput, reduce spare parts inventory and costs with well planned and data driven forecasts
• 10 step model - to be robust with being utilized in many areas of FDA and ISO

Operational excellence and value stream mapping in maintenance activities
Séamus Enright, Plant Manager, UCB group Shannon / UK

• First steps for process development and process improvement
• Management of quality and safety compliance.
• Kaizen, Six Sigma and continuous improvement in maintenance activities
• Human Error Prevention and Human Ressource Management in TPM programms
• Validation of maintenance and manufacturing processes and derivation for value stream mapping
• Building a Design for OPEX and TPM in for performance based maintenance

Genzyme's Asset Care Excellence Program (ACE) - Improving asset performance with a TPM approach in a sterile fill finish facility
Lorcan O'Toole, Reliability & Maintenance Lead, Genzyme Ireland Ltd.

• Genzyme Asset Care Excellence Program
• The equipment performance challenges in fill finish manufacture
• Selecting TPM as a route to delivering excellence in equipment performance
• Genzyme Waterford’s methodology and program for TPM implementation
• Benefits of TPM delivered to date
• Challenges of TPM as a maintenance improvement approach

Pfizer’s global reliability programme
Greg Julich, Global Director/Team Leader, Pfizer Global Reliability Programme / USA

• This global programme provides the systematic, coordinated activities and practices
• The programme effectively leverages change management processes to provide the influence, and value proposition for colleagues, supervisors and senior leaders
• Deployed across the Pfizer Network, supporting all divisions and operational units

Right First Time & Human Error Prevention @ UCB Ireland
Séamus Enright, Plant Manager, UCB group Shannon / UK

• How is RFT Measured? Why do we use this measure?
• What impacts RFT? How can we improve it?
• Human error – regulatory perspective /Human error – prevention
• Root cause – beyond human error

Interactive Evening Session:

A systematic and integrated approach for reaching maintenance excellence
Stefan Schäfer, Principal, Kienbaum Management Consultants GmbH

• Maintenance / Asset Management Transformation Factors
• Aligning strategic business requirements to deliver sustainable results
• How to assess Status Quo vs. Maintenance Excellence
• Behavioral Based Change and Sustainability

Increasing the OEE in a Pharmaceutical site through methodologies
implementation and a systematic approach
Frederico França Giunchetti, Head of Engineering, Sandoz do Brasil Industria Farmaceutica Ltda. / Brasil

This study will present a case in the Pharmaceutical industry where, after starting up a new site and understanding its competitiveness inside the Company and the Market, there was the need to redraw its processes regarding:

• Implementing OEE and its analysis from the beginning
• Understanding the root-causes of equipment stoppages
• Rebuilding the maintenance and production planning
• Training Operation and Maintenance teams
• Using the right equipment to the right product through a deep Process Engineering approach.

By using some tools from TPM (Total Productive Maintenance), implementing a losses tree structure for the main equipment and rebalancing the products in the lines considering capacities and flexibility, the Manufacturing and Packaging lines came up from around 20% to 50% of OEE in less than 24 mont

Leverage production automation through a knowledge based workforce
Robert Harrison, Industry Manager Pharmaceutical, COPA-DATA GmbH / Germany

• Simplify OEE generation and bring analysis to all levels of production processes. Make precise decisions on direct feedback in real-time to gain tighter process performance
• Make your systems deterministic to ensure business goals & targets are met
• Processing data to bring information to people in the format they need it
• Realize global communication within your facility through independence. You choose the ‘Best in Class technology’, connect to it and leverage information to bring business and production processes closer
• Use a configured system to reduce novelty & risk, therefore reducing the validation burden. Creating innovation in the world of regulatory compliance

Working Group 1
How to increase OEE & operational excellence
Dr. Joachim Reineck, Head of Manufacturing, Merz Group Services / Germany

• Best practices for managing OPEX
• KPI’s & Success factors and obstacles
• Lessons learned & Future Trends

Working Group 2
Using Manufacturing Execution Systems (MES) to improve operational efficiency
Andrew Whytock, Industry Manager, MES Centre of Excellence for Life Science, Siemens AG

• Reducing the gap between ERP systems and control/automation systems
• Using electronic batch recording for improving Right First Time, reducing cost and improving efficency
• Unifying manufacturing data to monitor performance and quality (OEE, SCADA, Historian)
• Business focussed case studies and project reviews

Working Group 3
Human Error Prevention & Root Cause Management in Pharmaceutical Operations
Dr. Ingrid Bause, Head Quality Engineering, Compliance Quality, Novartis Behring/ Deutschland/ Germany

• Understand human errors (facts and potential causes)
• Understand the importance from a regulatory and business point of view
• How to manage human error deviations
• How to support human reliability
• Root Cause Management to prevent and reduce deviations, i.e. identify effective CAPAs
• Human Error Prevention at Novartis

Working Group 4
Maintenance Cost Control Management
Fabrice Brion, Directeur, I-care sprl / France

• Facing opposite challenges: reduce maintenance cost and increase machinery availability
• Predictive and proactive maintenance as a solution to achieve targets and KPI’s
• Implementation of technologies to allow decrease unplanned downtime
• Shorten planned downtime by focusing resources on necessary actions

OEE – Tool for continuous efficiency improvement of packaging lines
Dr. Christian Jurisch, Principal Engineer, Head of Technical Services Pharma, Global Pharmaceutical Supply Group (GPSG), Johnson & Johnson / Switzerland

• Efficient capturing of equipment status changes (downtimes, setups, format changes)
• Tool for data analysis (OEE cockpits, dashboards)
• Organisation of the efficiency teams
• Excecution of improvement activities

Implementing Maintenance Excellence across the AZ facility maintenance teams in AZ UK Sites to deliver increased value to AZ, and reduce overall costs
Gary Butler, Director of Facilities Engineering Europe, AstraZeneca / UK

• Strategy for maintenance excellence
• Outsourcing philosophy and implementation
• Bringing Project Delivery and Maintenance together
• Successes and lessons learned

Risk Based Maintenance & RCM in a large capital project
Ferruccio Migliorini, Senior Manager Engineering /Maintenance HSE, Eli Lilly Italia SpA
Gianni Macchi, Maintenance Process Team Leader, Eli Lilly Italia SpA

• Front end loading and quality by design in a large capital project
• Risk based approach to C&Q and Maintenance program development
• Operational readiness, OEE & KPI`s
• One year later: Data, KPI´s & Evaluation regarding efficiency and ROI of the project

Auditing and qualifying suppliers and vendors: An effective risk based approach
Dr. Chandrashekar Nimkar, Head, Technical CompetencyCenter P.O. Sandoz Baug, Sandoz Private Limited/India

• Regulatory background and industry references and standards
• Selection of vendors/suppliers/service providers
• Audits – a risk-based approach to determine the requirements and levels of the assessments
• Approval of supplier/vendors: Quality agreement/contracts

Preparation and handling of FDA-inspections with focus on embedding of processes in an overall maintenance strategy and test tool interval dynamisation
Dr. Ralf Smounig, Director QA, ROCHE Diagnostics Graz GmbH

• How to handle FDA, ISO audits and authority inspections with focus on overall maintenance strategy
• Test tool as a full scale compliance back bone
• Test tool interval dynamisation on risk based approach
• Business excellence (EFQM) in overall maintenance concepts