| Day One1st December
2010 |
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| 08:00 |
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Delegate registration and refreshments |
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| 08:30 |
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| 08:35 |
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Restructuring operations to achieve operational excellence – aligning manufacturing, development and quality functions to a common goal |
- Developing a flat and cross-functional process-oriented organization in manufacturing
- Achieving significant reduction in throughput time, and enhancing "right first time" processes
- Defining clearer responsibilities during technology transfer to improve efficiency
- Improving transfer of know-how from development to manufacturing,
- Involving QA earlier in the process to address critical quality issues earlier
Jean-François Guilland,
IQP Head Global BPO,
Novartis Pharma AG
Switzerland
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| 09:10 |
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Integrating manufacturing with development – frontloading process development earlier in the product development process |
Aligning research, development and manufacturing to reduce development times and reduce time to market
- Promoting synergies, optimising communication and cooperating across disciplines with mixed team structures
- Considering process development, up-scalability and cost of goods during early development activities
- Allowing time for improvement with QbD activities and process optimisation before the drug reaches market
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| 09:45 |
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Pre-arranged one-to-one meetings |
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| 11:05 |
| Process intensification |
| Maximising output from current facilities - lessons from continuous manufacturing |
- Implementing lessons from continuous manufacturing in batch processing
- Maximising the output from a batch manufacturing facility without needing to invest in continuous processing
- Developing 'plug and play' technology to enhance flexibility in a multiproduct environment
Rick McCabe,
Senior Manager, Global Manufacturing and Supply,
Pfizer
USA
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| Quality by Design |
| Successful regulatory submissions for QbD - experiences in the CMC Pilot |
- Implementing a science- and risk-based approach to drug-development and manufacturing
- Developing a cross-functional team to successfully implement QbD
- Utilising the FDA's CMC Pilot Program to gain experience in the submission, review, and inspection of a pharmaceutical quality- assessment system
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| Brand protection |
| Anti-counterfeiting strategies from plant to patient |
- Implementing overt and covert track and trace technologies to identify legitimate pharma products
- Overcoming the problem of parallel trade and product re-packaging - taking track and trace technologies closer to the final product
- Understanding the impact of EFPIA serialisation and US e-pedigree initiatives on anti-counterfeiting strategies
- The role of effective distributor and consumer education in preventing the problem of counterfeit drugs
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| 11:45 |
| Operational excellence |
| Improving pharmaceutical product development
and manufacturing |
Impact on cost of drug development
and Cost of Goods Sold of pharmaceuticals
- Reorganising the structure of operations for more effective communication and decision making
- Eradicating non-value activities and improving efficiency of essential functions
- Engaging the workforce to implement changes across the shop floor
- Sustaining changes beyond the first wave of implementation
Dr. Prabir Basu,
Executive Director,
NIPTE
USA
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| Design for Six Sigma |
| Using Design for Six Sigma to achieve Quality by Design
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- Understanding the complementary nature of DfSS and QbD
- Employing a systematic and structured approach to product development to increase process knowledge
- Enhancing QbD tools with lean tools from DfSS to further improve process development
- Improving manufacturing of legacy products with DfSS
- Aligning operational excellence and quality functions with complementary tools and outcomes
Jonathan Walker,
Head, cLEAN® Program and Master Black Belt,
Novo Nordisk Pharmaceuticals
USA
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| Supply chain security |
| Preventing product loss and managing global trading networks - maintaining the integrity of your supply-chain
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- Overcoming global threats to the supply chain when extending operations in to global trading networks
- Effectively monitoring shipments from the manufacturing facility to the point of distribution
- Preparing an effective logistical plan to alleviate stoppages and ensure security at every step of the distribution
- Assessing and managing the risks associated with global operations
- Packaging and tracing technology to prevent counterfeit products entering the legitimate supply chain
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| 12:25 |
| INTERACTIVE WORKSHOP |
| Overcoming the challenges to lean implementation |
- Identifiyng opportunities and prioritising implementation of lean projects
- Understanding ROI of the lean initiative
- Quantifying the systemic impact on the value stream
- Sustaining improvements after Kaizen
- Creating a cultural change and getting the “buy-in” for success
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| INTERACTIVE WORKSHOP |
| Manufacturing 'Right First Time' through effective implementation of PAT |
- Real time analysis of quality - improving process understanding
- Eliminating the need for post-process testing
- Reducing product wastage from off-spec production
- Effectively storing and analysing data to enhance processes
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| INTERACTIVE WORKSHOP |
| Pharmaceutical packaging and labelling |
- Innovative packaging solutions for brand protection and product security
- Creating the optimum level of product safety and stability
- Preventing product recalls by utilising quality materials and meeting packaging regulations
- Controlling packaging costs by identifying the appropriate material
- Developing sustainable pacakging
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| 13:25 |
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| 14:30 |
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Outward looking pharma – lessons for pharma manufacturers from other industries |
- Integrating techniques used in automotive and advanced manufacturing industries in to the pharma manufacturing plant
- Understanding the similarities of pharma manufacturing with other industries in order to identify synergies and improve processes
- Developing ‘just in time’ procedures - becoming a demand driven industry
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| 15:00 |
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Pre-arranged one-to-one meetings |
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| 16:45 |
| Lean six sigma |
| Achieving a sustainable cultural change, engaging the shop floor |
- Overcoming cultural barriers to change - understanding the employee mindset and effectively communicating the need to change
- Encouraging employee feedback and input in to the change process to ensure commitment to the project
- Managing lay-offs and the effects on employee morale
- Ensuring transparency during the change process to build trust and improve morale
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| Real time release |
| Implementing effective monitoring systems to remove the need for end of line testing |
- Moving towards Continuous Quality Verification for real-time release of an end product without final quality testing
- Ensuring effective collaboration between process development, manufacturing and quality functions to implement an effective monitoring system
- Utilising PAT and QbD to achieve real time release
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| Supply chain management |
| Implementing a successful supply chain management system to manage inventory and reduce time to market |
- Integrating demand-supply planning, monitoring and response
- Achieving dramatic inventory reductions to reduce cash tied up in stock
- Improve forecasting in a demand driven supply chain
- Aligning demand plans, supply plans and all business functions to achieve desired operations performance
- Reducing risk across the supply chain
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| 17:25 |
| Pull manufacturing |
| Implementing a pull-based system in manufacturing operations |
- Reducing waste and optimising efficiency across the plant
- Managing a lean transformation resulting in an increase in efficiency and lead time reduction
- Creating a pull-system in manufacturing operations - meeting customer demand and reducing waste
- Optimising efficiency whilst creating a sustainable change and overcoming resistance on the shop floor
Stefano Carella,
Master Black Belt,
Merck Sharp & Dohme
Italy
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| Continuous manufacturing |
| Developing a continuous manufacturing process for secondary manufacturing |
- Meeting regulatory requirements for QbD with continuous manufacturing
- Applying lessons learned from API continuous manufacturing to secondary processing
- Understanding the business case for investment in continuous manufacturing
- What can pharma learn from other industries with regards to continuous processing?
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| Cold chain |
| Developing a compliant and cost-effective cold chain
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- Preventing temperature-sensitive product loss
- Implementing technologies for monitoring and tracking temperatures
- Preventing cold chain deviation right in to the last miles of distribution
- Managing cold chain integrity in third party distributors
- Ensuring regulatory compliance and preventing product loss with efficient logistical processes
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| 18:00 |
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Speaker Panel Discussion: Does a lean six sigma programme guarantee Quality by Design? |
Are LSS and QbD complementary or separate issues?
- Does implementing QbD automatically result in a lean culture?
- Who should contribute to the implementation of LSS and QbD - should it actually be carried out by the same people?
- Is QbD simply a scientifically based version of operational excellence?
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| 18:35 |
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