Identifying and applying innovative tools to maximise the quality and efficiency of your manufacturing process

• Evaluating the solutions that guarantee lower expenditure, premium quality and shorter lead-times
• Reviewing how successfully Lean and Six Sigma have been applied in pharmaceutical and bio manufacturing environments
• Assessing the impact of outsourcing on quality and productivity standards
• Driving and maintaining quality when working across a diverse product portfolio

Greg Watts, Manufacturing Improvement Manager
PROCESS INDUSTRIES CENTRE FOR MANUFACTURING EXCELLENCE (PICME)

Integrating knowledge management with process understanding, Quality by Design and PAT

• Applying PAT, GMP, QBD guidelines and determining where they fit in your production plans
• Determining the potential of knowledge management models and how they can be leveraged to drive operational success
• Pinpointing where the major challenges lie in implementing QBD and PAT starting from the R&D practical framework
• Evaluating the important differences between traditional and Quality by Design (QBD) development environments

Jean-Marie Geoffroy, Director, Pharmaceutical Development
TAP PHARMACEUTICALS

Tackling the major challenges of implementing PAT into your existing infrastructure for improved quality results

• Evaluating the best ways to introduce PAT into your facility
• Choosing the best infrastructure to accommodate PAT integration
• Effectively planning which facilities are best to prioritize PAT and then how to phase it in to the rest of your facilities
• How to use PAT to release Lean thinking

Tom Cochrane, Business Process Development Manager
NAPP PHARMACEUTICALS

Developing a flawless integrated quality risk management strategy to eliminate the threat of emerging vulnerabilities

• Re-designing your risk management approach with emphasis on the root stages to better offset weaknesses
• Identifying the key applications of advanced methods for process design/control and for process improvement
• Effectively communicating your risk management plan to partners to ensure seamless quality controls
• Experiences of process design and control and process improvement

Marco Lupo, Advanced Methods, Process & Methods Manager GPSG EMEA
JOHNSON & JOHNSON ITALY

Applying risk management and quality control standards that are specific to biopharmaceutical products

• Understanding the complexities of quality control when manufacturing bio products and fermentation
• Determining the quality constraints of high volume bio manufacturing
• What aspects of the risk management process need to be enhanced?
• Evaluating novel technological approaches to drive quality and efficiency
• Applying Lean and Six Sigma in bulk biopharmaceutical production

Cynthia Wooge, Manager, Process Development
SAFC PHARMA

Striking the balance between quality and efficiency when manufacturing a diverse product portfolio

• Standardising quality objectives across different manufacturing processes
• Making the most of technology to help streamline multiple production facilities with different chemical compounds and quality standards
• Up skilling your workforce to ensure quality standards are maintained in a multi-production facility
• Utilising key tools such as metrics and trending of quality data to monitor the success of your systems

Mathew Cherian, Senior Technical Director
PATHEON PHARMACEUTICAL SERVICES

Effectively linking your manufacturing process improvement with the wider supply chain

• What do PAT, QBD and Lean Six Sigma mean in R&D?
• Is PAT really Lean?
• Aligning the unique quality and design elements from R&D to your manufacturing process design
• Determining the differences in manufacturing excellence to R&D
• How to ensure your operational excellence and quality control systems from R&D to manufacturing continue to function effectively

Rachel Brody, Principal Scientist, Process Analytical Technology
PFIZER GLOBAL

Quality and productivity control zone – roundtable discussion and debates

Take this chance to come together to discuss and debate the latest issues around quality control and Lean process implementation to enhance the productivity and excellence of your facility. This roundtable will gather the key speakers and topics of the day and allow you to put crucial questions to the speaker on the roundtable of your choice. Roundtable discussion sessions cover:

• Regulatory issues and their impact on your facility
• Implementing robust risk management tools
• The unique challenges for biopharmaceutical manufacturing
• Designing and implementing Lean Six Sigma
• Achieving successful data integration
• Using outsourcing as a tool for improved quality control and operational efficiency

Implementing Six Sigma and Lean manufacturing in a complex and constantly changing supply chain

• Identifying the key factors that have inhibited the full success of Lean Six Sigma implementation
• Determining key infrastructure requirements to ensure successful Lean Six Sigma implementation
• Combining Lean Six Sigma with PAT to maximise quality and efficiency
• Building flexibility into your structures to support fluctuations in production

Dr. Fadel Hamed, Head of Operational Excellence
GENENTECH, INC.

Maintaining your compliance standards through strategic integration of Lean Six Sigma

• Understanding your compliance standards and its cost impact on your facilities
• How to best make use of your facilities to further quality and productivity by integrating Lean Six Sigma with compliance
• Integrating the supplier development process into the business process excellence scheme
• Identifying the most effective compliance process and understanding how it relates to compliance standards

Dr Siegfried Schmitt, Principal Consultant
PAREXEL CONSULTING

Extending your quality and efficiency standards to your outsourcing partners

• Establishing the rate of growth in contract manufacturing and its implications for quality control
• Examining how CMOs are pro-actively driving quality and performance standards in their facilities
• Harmonising your production targets to improve reliability
• How to further extend your standards when working with third party alliances

Dr Ranjana Pathak, Vice President Quality Assurance
ENDO PHARMACEUTICALS

Best practices for improving lead time of technology transfer to contract manufacturing organization

• Identifying key barriers to effective relationship management and quality control
• Determining optimal KPIs and monitoring systems for managing partner performance
• Communicating and transferring your key end project goals to maintain quality and operational excellence

Dr. Nkere Ebube, Director, Technical Operations
ALPHARMA PHARMACEUTICALS

Facilitating rapid skills and technology transfer to outsourcing partners to maintain quality and efficiency

• Evaluating the most cost effective methods of achieving rapid transfer e.g. virtual plants
• What processes and skills transfer are necessary to ensure operational excellence?
• Ensuring the most effective technology transfer process to guarantee stability and high product quality

Cristina Vale, Senior Process Engineer
AVECIA

Panel session: Minimising risk and maximising manufacturing quality when outsourcing abroad

• Key factors to consider when selecting partners abroad
• Benchmarking quality and regulatory standards between Europe and emerging markets
• Adopting appropriate monitoring systems to achieve quality and efficiency from emerging market partners
• Lessons learnt from emerging market case studies to date

Panellists include:
Jacques Navellou, Senior Director External Manufacturing
SANOFI PASTEUR

Dr. Nkere Ebube, Director, Technical Operations
ALPHARMA PHARMACEUTICALS

Dr. Ranjana Pathak, Vice President Quality Assurance
ENDO PHARMACEUTICALS

The importance of Six Sigma implementation in a strong expansion phase

• Why Six Sigma really can help in an expansion phase
• The Schott Six-Sigma concept
• A case study from a supplier of the pharmaceutical industry

Dr. Alexander Huber, Head of Production
SCHOTT SCHWEIZ AG

Improving process productivity and quality input through the motivation of people in pharmaceutical and bio manufacturing facilities

• How to effectively improve process productivity by reducing cycle times of releases and bottlenecks in QC and testing
• Utilising key tools such as metrics and trending of quality data to monitor the success of your process and increase quality output
• Clarifying the key role people play in delivering productivity and quality within the facility
• The best approaches to increasing staff motivation and decreasing frustration with complex systems and processes

Massimo Appiotti, Partner
VALEOCON MANAGEMENT CONSULTING