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2012 Conference Programme
Technology Day | day
one | day two
Programme - Focus Day26th November 2012
Effective Strategies in Ensuring Tech Transfer is Done Right First Time
Deploying a strategy that avoids unnecessary time and costly burdens
- Establishing the best practices for ensuring successful transfer
- Taking a holistic approach to all tech transfer scenarios
- Preparing for forecasted challenges to eliminate any additional costs
- Establishing the boundaries between development and tech transfer from the start - Avoiding having to take steps backwards
Building Value through Your Suppliers
- Ensuring only the best talent when selecting a vendor
- Minimizing the number of vendor collaborations to boost efficiency & productivity
- Establishing any vendor weaknesses and working with them to find an effective remedy
- Utilising leading monitoring systems in remaining on top of third party efficiency
New online technology for high sensitivity broad dynamic range assays of complex in-process material
- Utilising PAT to improve recovery, ensure final product quality and yield, and to achieve business objectives
- Achieving real-time LC analysis of complex inprocess samples in the production environment
- Efficient design of an effective QbD strategy in manufacturing
Lean-designed Tech Transfer Services
Extending lean principles to include the tech transfer process
- Generating a worthy and deployable lean transfer process
- Ensuring buy-in by those involved on both sides of the tech transfer
- Sustaining lean goals post-transfer and extending this to the manufacturing process
Balancing R&D Creativity with Lean Streamlining
- Prioritising team engagement & understanding
- Realising that lean in R&D can mimic but cannot not mirror manufacturing principles
- Maximising process understanding and mapping to limit waste, time & cost
Making use of OEE in Pharmaceutical Manufacturing
Reaching the efficiency levels seen in other process-orientated industries
- Improving efficiency, availability and performance of the manufacturing process
- Reducing downtime and manufacturing costs whilst improving time-to-market
- Optimising the use of the available equipment in boosting sustainability whilst being more cost-effective
Extending Lean Principles Beyond Manufacturing and into the Entire Value Stream
- What aspects of lean manufacturing are immediately transferable?
- Highlighting those aspects that demand conversion - Enhancing communication between the manufacturer and supply chain team
- Deploying lean principles throughout the Big Five - Development, Procurement, Manufacturing, Warehousing, Transportation
Increasing OEE Throughout Manufacturing Operations
- 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
Lean Supply Chain Management
- Restructuring the overall operation strategy and key processes
- Ensuring streamlining of flow between manufacturing & transportation
- Key strategies in maximising relationships with your suppliers
Technology Day | day
one | day two
Programme - Day One27th November 2012
How can the manufacturer prepare to meet the ever more stringent regulations being published?
- The Falsified Medicines Directive - Ensuring harmonised, pan-European safety and control measures are met
- Developments in Pharmacovigilance - Modernizing existing systems to meet the quality control and patient safety parameters
- What measures are in place by the Regulators to boost the harmonisation of legislative action across the continent?
Breaking the mould to promote a paradigm shift in how operations can grow your business
- Leveraging operational excellence initiatives in driving business growth
- Analysing the true technical principles behind a shift in excellence
- Understanding how the technicalities of OpEx influence business productivity
- Calculating integral analysis of your operations
- Creating the ‘Walls of the Innovation Funnel’ in driving new products to market
- Interactive Exercise: Addressing the nine tough questions that enable Operational Excellence
Striking a Balance between People Engagement & the Lean Toolkit
Case Study
- Abandoning the 'top to bottom'-type model - Evaluating what level of understanding is needed throughout the hierarchy
- Assuring buy-in from those deploying the programme & deep understanding from those executing it concurrently
- Managing the complexity of lean to streamline its sustainability whilst maintaining technical detail
- Flexibility in Lean - Assessing the natural inclinations of your personnel & adapting the model accordingly, taking mentality into consideration
Adopting an Holistic & Integrated approach to QbD Implementation
- Involving manufacturing input in product and process design in early phase development
- Patient-centric QbD - Designing the manufacturing process according to the needs of both the product and patient
- Generating site-specific risk assessments
- Deploying an effective quality control and monitoring strategy
- Integrating QbD with existing quality management systems
Clarifying the Industry's Definition of Tech Transfer in Strengthening Standardisation
Understanding the industry's expectations of tech transfer
- Realising the difference between tangible technology transfer and human knowledge tech transfer
- Best practices in translating intangible technology to transferable data
- Engaging key discussions in knowledge management & sharing
- Ensuring human 'technology' is titrated between levels - Facts, knowledge & experience
- Tackling an ageing workforce - Why does Grandad always know more?
Formulating a Winning Strategy in Reaching Operational Excellence
- Supporting all levels of the organisation during a lean transformation
- Best practices in implementing and sustaining vital cultural change
- Incorporating existing core principles and systems with lean values and culture
- Determining key challenges areas and resolving them efficiently
Reducing Risk Throughout your Supply Chain
Utilizing a Process Intelligence Platform that spans organizations and geographies
- Realizing supply chain benefits of QbD tech transfer to reduce risk within & between organizations
- Utilizing process intelligence platforms to provide self-service data access, aggregation, contextualization & analytics
- Reporting capabilities to span local and geographically remote process development, quality assurance and manufacturing operations
The Need for Lean Models in Optimising the Tech Transfer Process
- Effectively incorporating lean principles into new & existing tech transfer protocols
- Facilitating the flow of scientific knowledge
- Reducing costs, risks and time related to tech transfer
- Sustaining quality in a more effective and productive manner with lean
Leaflets, Labels & More: Partners in Logistics
- Understanding how vendors can manage inventory
- Implementing a 'just in time' strategy
- Utilising Electronic Data Interchange (EDI) for orders and invoices
- Sharing best practices in completing your projects
Benchmarking & Continuous Improvement of Quality Systems
Measuring and optimizing compliance and performance of quality systems in an intelligent way
- Exploring the fundamentals, methodology & concept of Quality Intelligence
- Presenting the diagnostic tool (Q- MoD) that captures regulatory requirements and industry guidelines
- Considering best practices in risk management, lean, agile practices, World Class Manufacturing & other best-in-class sources
- Client case study - Illustrating the QI-methodology on a quality operations topic
- Demonstrating assessment performance & a real deployed diagnostic
Led by Horvath & Partners
Christian Daxböck
Principal, Head of Business Segment, Supply Chain Management
Horváth & Partner Management Consulting GmbH Germany
Christoph Ebensperger
Principal, Head of Business Segment Life Sciences
Horváth & Partner Management Consulting GmbH Germany
Titrating Excellence throughout the Organisation
Case Study - Finding the right level of lean at each level of the organisation
- IT & analytical testing to gather concrete data of lean benefits at each level
- Ensuring that, at the start of each lean journey, a specific process or division will truly benefit
- Truly understanding the psyche of each level and pinpointing what the barriers to change are
- Establishing models to forecast long-term success
- Deploying the most effective training schedules and content for each level
Structuring Quality System Improvements using QFD Strategies
- Realising the true potential of QFD as a functional precursor to QbD implementation
- Prioritising the reduction of process complexity in highlighting discrepancies
- Simplifying to the root cause vs additional process instalment
- Characterizing key processes and business outcomes for comparison with predetermined benchmarks
- Evaluating what areas should be targeted as a matter of priority in rolling out the most promising outcomes
- Generating key implementation & improvement strategies moving forward
Best Practices in Converting an Inhouse Facility into a Successful CM Venture
- Exploring the benefits & challenges of insourcing
- Efficiently utilizing facility capacity & equipment
- Process design & development
- Regulatory considerations in design space and insourcing
- Implications of insourcing on existing inhouse manufacturing
Pitching your Existing Operational Excellence Programme against that of the US army
Promoting strategic alignment, performance improvement, and innovation throughout global operations
- The US Army at a Glance – Key facts & figures of size, people, facilities & global presence
- Generating a deployment plan for transformational change – ‘As is’ vs ‘To be’
- Facilitating lasting change in governance, business process mapping & shop floor culture using CPI/LSS initiatives
- Deploying the CPI/LSS programme throughout the strategic, operational & tactical levels
- Selecting the extent of lean & recognising the main areas of focus at each subsequent level to promote lasting change
- Ensuring enduring Army competency through the maturity model via CPI/LSS performance & end-to-end process management
Kirk Nicholas
Director, Lean Six Sigma Programme, Office of Process Improvement, Office of Business Transformation
US Army USA
Product Quality & Safety – Preparing your Organisation for Product Recall & Outbreaks
Protecting consumer health & product image through effective generation of recall and worst case scenario strategies
- Exploring clear processes & decision-making plans to limit delays in targeting the problem
- Identifying the extent of an issue rapidly and ensuring effective solutions are to hand
- Generating & deploying pre-determined recall plans and incident teams in limiting production downtime
- Effectively notifying regulatory authorities, retailers & consumers
- Mitigating product safety & quality incidents from going viral in a digital age
- Promoting the exchange of relevant information in a timely manner to the right audience in maintaining brand integrity
The Best IT Systems in Supporting a Productive Manufacturing Framework
Case Study
- Diagnostic evaluation of facility excellence - Highlighting gaps in manufacturing productivity
- Establishing what areas are challenged and within what order they need to be remedied
- Structuring similar faulted sites into networks and ensuring that the challenges are tackled, under control and solutions made as effective as possible
- Releasing lean into these faulty areas slowly and in a controlled manner to prevent short-term issues and ensure long-term success
Technology Day | day
one | day two
Programme - Day Two28th November 2012
Finding a Common Language between Regulators across the Continent
Maria Arfwedson
Director and Head, Pharmaceutics & Biotechnology
Medical Products Agency (MPA) Sweden
Overcoming the challenges of surviving in a generics environment - Lessons to be learnt
- Realising governmental pressures of utilising only the cheapest manufacturing processes
- Evaluating every potential risk to quality when turning to cheaper processes
- Determining what is negotiable in product quality so costs can be reduced in the short-term
- Generating a longer-term strategy to ensure quality parameters continue to be met whilst maintaining cheaper operations
The Shingo Model in Driving & Assessing Transformational Change
- Understanding the difference between lean tools, lean management systems, and lean principals
- How striving to understand lean principals can transform your corporate culture
- Implementing lean manufacturing practices into the organisation
- Improving core business processes
- Using the Shingo Prize Model as a benchmark for success
Understanding the Serialisation Legislation - Where are we Now and What is to be Expected?
Case Study: Preparing your Manufacturing Operations for Emerging Legislation
- Understanding the discussion strategy between the industry and the EU commission - Input & response
- Clarifying the technical details of the legislation to date and filing industry data, concerns and queries
- Generating a strategy without full legislative information & requirements - Preparing for the unknown
- Concerning China - Realising the additional requirements of the East & preparing your global suppliers
- Case Study USA - E-pedigree pilot strategy
- Case Study Germany - E-pedigree pilot strategy
Dr Hans-Walter Hoehl
VP Global Strategy & Projects, Pharmaceutical Production
Bayer HealthCare Germany
Introducing New Technologies to Accommodate the Personalised Therapy Trend
Case Study
- Utilizing strict process engineering strategies to generate a process plan to efficiently manufacture personalised products
- Incorporating these strategies into start up plants to reach a production baseline
- Introducing process improvements in existing sites to reduce exceptions and streamline process flow
- Advancing automation in facility design and process development
- Overcoming the challenges linked with complex personalised scheduling
What is the Next Level of Operational Excellence?
Defining Concrete ROI on your Lean Projects
What are the Engineering Realities of Lean Start-up & Maintenance?
Determining Key Considerations of Greenfield & Existing Facility Design & Upgrade
IT & Automation in Strategic Planning
Managing your CMO Relationships
OpEx - Exploring why good analytics is better than good theory
- Understanding the tippling point at which stabilization and level flow becomes more important than longer runs
- How can supply chain behaviours impact cost drivers and conversion costs and service?
- How can you rightsize inventory and why is right sizing better than reduction?
- How business imperative influences appropriate choice of value platform : Comparative reflections on Pharmaceutical, Generics, Biopharma, Medical Technology, Big Drink, Private Equity and Healthcare distribution
Supply Chain Quality & Integrity
Drug Anti–counterfeiting and Pharmaceutical Supply Chain Integrity
- Verification, Authentication, ePedigree and Tracking & Tracing
- Implementing an integrated mass-serialisation and pedigree application
- Sharing serialised product data across the supply chain
- Overcoming the risks of counterfeit and diverted drugs entering the drug distribution supply chain
- Improving supply chain and brand integrity
- Combining serialisation and pedigree management in a single, integrated application delivering regulatory compliance and business value
Facility Design and Upgrades
Transforming How the Pharma Industry Approaches Drug Manufacturing
- Delivering speed and capital efficiency with control and long-term solutions
- Integrating and simplifying facility operations and systems
- Designing sustainability into the facility to reduce water and energy usage
- Eliminating the need for CIP/SIP rooms and infrastructure
- Flexible solutions in promoting multi-product manufacturing
Moving beyond Conceptual Thinking in Getting the Most from your OpEx Programme
Case Study
- Prioritising leadership engagement in supporting OpEx success
- Applying a focussed approach to train company leaders – Identifying how best to strengthen your staff, facility & overall operations
- Adopting a fully integrated strategy – Building shop floor initiatives into OpEx at the leadership level
- Highlighting what the shop floor really needs from you as a leader
- Generating a broader OpEx map for the shop floor roll-out
Understanding the RTRT 2012 Guidelines & its Implications on API & Finished Product Manufacturing
- What are the benefits of RTR over a traditional end-product testing strategy?
- What are the production specifications of RTRT?
- Winning strategies in applying RTRT to existing processes
- Extending RTRT to the production of biologicals
- Following documentation guidelines in remaining compliant
Maria Arfwedson
Director and Head, Pharmaceutics & Biotechnology
Medical Products Agency (MPA) Sweden
Establishing Continuous Manufacturing in Pharmaceuticals
Exploring the “ultra-lean” way of manufacturing – Considerations from development and production
- Continuous manufacturing technologies and engineering efforts
- Overcoming the task of implementation
- Efficient process development within the continuous manufacturing paradigm
- Understanding the benefits of continuous manufacturing within R&D and commercial manufacturing
- Process control, QC- and Release concepts
- Understanding the regulatory aspects
Do Holistic Lean Models Really Work in a Globalised Arena?
Holistic vs Agnostic deployment
- Post-holistic lean deployment - Has a 'big picture' strategy generated the desired results?
- Highlighting the key differences between global facilities that generate challenges to holism
- Evaluating key requirements and adapting lean models down to a facility basis
- Recognising where holistic measures can be afforded and where a more agnostic approach must be adopted
Deploying PAT Systems to Support RTR Testing Pre-approval
Case Study: Reducing manufacturing timelines, whilst boosting product quality & validation
- Installing & maintaining PAT systems throughout manufacturing
- Utilizing near-infrared spectroscopy (NIRS) to rapidly penetrate batches & collect product data for analysis & validation
- Analysing overall time & resource savings vs traditional high-performance liquid chromatography (HPLC) technologies
- Submitting & justifying market applications to global regulators and overcoming key hurdles in approval
- Improving QbD deployment & maintenance
- Massively reducing down-time post-approval in cases of product recall
How is Technology being used to Deliver on Manufacturing Strategies?
Case Study
- Understanding past strategies of tackling data vulnerability – Application-based approaches
- Securing risk assessment, parallel to the move to a more automated system
- Evaluating how risk & security have changed following automation & integration
- What data is critical? Can it be corrupted between the shop floor and management?
- Generating global technology tools & applying them to boost business
Technical Operations in Streamlining Vaccine Production
Case Study
- Re-defining what the customer-orientated focus of each manufacturing process should be
- Tackling the challenge of high discard and deviation rates in vaccine production
- Embedding technologies with operations in reducing error and waste
- Adapting the Toyota Six Sigma model to vaccine production
- Effectively utilising resources to reduce timelines, boost production and boost cost efficiency
Developing a Risk Based Approach to Quality Management
- Adapting quality management systems in avoiding & responding to product recalls
- Reviewing quality, safety and regulatory procedures across the product portfolio
- Implementing failure mode & effects analysis (FMEA) to develop an integrated risk management programme
- Meeting the changing ICH Q guidelines
Developing a Matrix-based Supply Chain Organisation
- Enhancing productivity, quality and throughput
- Shifting supply chain paradigms: from bottom and service level focus to holistic business contribution and partnering
- Integrating the supply chain with R&D and commercial functions to improve decision making and quality
- Expanding into new territories via extended distribution models
- Enabling growth through sourcing in external innovation
Translating Lean Principles from Manufacturing to Innovative & more Technical Development Stages
- Best practices in integrating operational excellence into the highly technical R&D environment
- Bringing standardization methodologies into R&D - A short-term hindrance with long-term benefits
- Reducing timelines & inefficiencies in boosting development success
- Enhancing manufacturing efficiencies with a leaner product from the start
- Ensuring cultural buy-in and principle maintenance
Uncovering and Correcting Lost Green Opportunities in Manufacturing
Fully understanding operational inefficiencies
- 'Green' personnel visits to the facility floor to monitor operations and processes first hand
- Enhancing product and process knowledge amongst all personnel to increase waste awareness
- Collating data to improve processes and cut operation costs across the facility
- Further collation of facility data in the generation of a global sustainability strategy
Saving on capital spending whilst improving process efficiency and productivity
- Adopting a holistic approach to investing in existing facility enhancements
- Combating rising costs of manufacturing with COG reduction
- Building COG reduction into the development of the 'facility of the future'
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