World Drug Manufacturing Summit 2010

Increasing innovation and reducing costs across global operations.


Berlin, Germany
30th November – 2nd December 2010


pre-event | day one | day two

Focus Day30th November 2010
13:00
Delegate registration
13:30
COGS FOCUS DAY
Achieving COGS reduction for legacy products
Implementing second generation process improvements
  • Redeveloping the manufacturing processes to reduce COGS and revitalise old products in new markets
  • Product lifecycle management and the role of new formulations on COGS - impacts on manufacturing
  • Remaining competitive against generic products - developing strategies to reduce COGS and maintain profitability on key products
 
TECHNOLOGY TRANSFER FOCUS DAY
Implementing operational excellence methodologies in technology transfer
Streamlining the technology transfer process - improving efficiency and reducing costs
  • Developing an efficient process in the pilot plant
  • Effective data management to ensure facilitate the scale-up and technology transfer process
  • Developing a multi-functional team to manage all aspects of the technology transfer
 
14:05
INTERACTIVE WORKSHOP
Uncovering unrealised benefits of an MES system - achieving COGS reduction
  • Maximising performance of MES to reduce purchasing costs, logistics costs and cycle-time
  • Minimising material and time wastage by manufacturing right-first-time
  • Utilising a MES to reduce material costs, inventory and the overheads required to manage these
  • The impact of improved efficiences on COGS
 
INTERACTIVE WORKSHOP
The contract manufacturers perspective on efficient technology transfer
  • Regulatory and compliance issues in tecchnology transfer - achieving cGMP
  • The importance of communication and accountability
  • CMO requirements for technical information from the customer - what makes a good technical package?
 
15:35
Refreshments
15:50
Process economics for COGS reduction
Understanding the contribution of key manufacturing functions to COGS
  • Considering COGS during the process development phase
  • Developing a cross-functional team to develop an integrated approach to COGS reduction
  • Impact of generics on COGS - remaining competitive in a tightening healthcare environment
 
Achieving efficient technology transfer into contract manufacturing operations
  • Developing a detailed technology transfer report assessing the current state of the technical knowledge
  • The role of pilot plants in effective technology transfer - ensuring transfer is a success on a small scale
  • Setting clear objectives and ensuring effective communication between the project managers on both sides of the transfer
  • Overcoming distance and cultural barriers when transferring technology to global locations
 
18:30
Chairman's closing remarks

pre-event | day one | day two

Day One1st December 2010
08:00
Delegate registration and refreshments
08:30
Chairman's introduction
08:35
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
09:10
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
09:45
Pre-arranged one-to-one meetings
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
 
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
 
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
 
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
 
Design for Six Sigma
Using Design for Six Sigma to achieve Quality by Design
  • 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
 
Supply chain security
Preventing product loss and managing global trading networks - maintaining the integrity of your supply-chain
  • 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
 
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
 
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
 
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
 
13:25
Networking luncheon
14:30
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
15:00
Pre-arranged one-to-one meetings
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
 
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
 
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
 
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
 
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?
 
Cold chain
Developing a compliant and cost-effective cold chain
  • 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
 
18:00
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?
18:35
Drink's reception

pre-event | day one | day two

Day Two2nd December 2010
08:00
Morning refreshments
08:40
Chairman's introduction
08:45
Retaining the employee skill base and ensuring employee engagement during changes in manufacturing operations
Avoiding loss of expertise and retaining a critical skill base
  • Identifying critical functions and key workers
  • Encouraging employee loyalty through effective communication and a culture of transparency
  • Dealing with changes in the workforce due to mergers and acquisitions - identifying and retaining talent
  • Developing employee commitment through effective personal development
09:20
Sustainable manufacturing strategies for COGS reduction
Reducing costs with energy management and sustainable technologies
  • Minimising the environmental footprint by increasing efficiency and controlling the use of resources
  • Involving the workforce in the green process - extending changes into everyday operations
  • Moving towards the use of less hazardous materials to minimise the environmental impact of manufacturing operations
  • Delivering bottom-line benefits whilst enhancing CSR and improving relationships within the community
10:05
INTERACTIVE WORKSHOP
Veolia Workshop
Veolia

 
INTERACTIVE WORKSHOP
Horvath & Partners Workshop

 
INTERACTIVE WORKSHOP
Orbsen Consulting Workshop

 
11:05
Refreshments
11:30
Energy management
Implementing an effective energy management programme – achieving significant cost reductions
  • Finding hidden energy usage to identify opportunities for significant cost reductions
  • Installing effective energy monitoring systems to maintain energy reduction and spot ‘leaks’
  • Utilising renewable energy sources to further reduce costs
  • Controlling energy consumption to reduce operating costs and maximise profits
 
FMEA
Managing process risk through application of FMEA
  • Developing more robust processes and eliminating the need for corrective action
  • Reducing the cost of quality - effectively detecting and preventing product failures
 
Strategic sourcing
Continuously improving and re-evaluating purchasing activities to reduce costs and ensure security of supply
  • Developing a risk based approach to supplier identification and engagement
  • Monitoring supplier quality and reliability to ensure consistency in manufacturing operations
  • Identifying suppliers based on value and reliability - balancing cost and quality
 
12:10
INTERACTIVE WORKSHOP
Facility management strategies - maximising plant availability
  • Achieving greater efficiency and optimising operating processes
  • Ensuring reliability of plant equipment
  • Energy management systems to reduce overheads
  • Deveolping a facility for rapid and low-cost development and manufacture of complex products
 
INTERACTIVE WORKSHOP
On-demand data access across pharma manufacturing – connecting global operations
  • Developing full process understanding for efficient pharmaceutical production
  • Implementing a fully integrated IT solution to achieve operational excellence
  • Moving from paper based documentation to electronic batch records
  • Implementing a cross-site, cross-company solution for data management
  • Allowing manufacturing teams to collaborate effectively through effective data management
 
INTERACTIVE WORKSHOP
Global contract manufacturing strategies – risks and rewards of out-sourcing to Asia
  • Developing a high quality custom manufacturing plant in Asia
  • Meeting customer demands for superior quality products and services
  • Investing in the latest technologies to offer cutting edge services to customers
  • Overcoming the cultural and distance barriers to maintain effective relationships with global companies
 
13:10
Themed luncheon discussions
14:30
Overall equipment effectiveness
Achieving OEE in pharma packaging lines
  • Improving efficiency, availability and performance of the packaging line - impact on the entire manufacturing process
  • Reducing downtime and manufacturing cost whilst improving time-to-market
  • Making the best use of the equipment and reducing costs
 
Global operations
Manufacturing in Asia - build vs. buy decisions
  • Developing a presence in emerging markets with manufacturing facilities in Asia
  • The advantages and disadvantages of inheriting manufacturing facilities through acquisition of a local company
  • Understanding cultural and regulatory influences on manufacturers in Asia
 
Contract manufacturing
CMO relationships – identifying reliable partners, managing technology transfer and maintaining effective relationships
  • Implementing a project team with representatives from both parties to successfully manage the relationship
  • Setting targets and monitoring productivity to ensure success
  • Managing the technology transfer process from both sides
  • Overcoming the cultural and distance barriers to maintain effective relationships with global companies
 
15:10
Asset management
Improving asset performance with total productive maintenance
  • Defining ideal work process for maintenance and assessing the current situation, in order to implement change
  • Identifying strengths and weaknesses and setting up a maintenance improvement plan
  • Standardising maintenance methodology for key equipment and implementing this across multiple sites
  • Ensuring quality, safety and compliance whilst reducing costs through an effective maintenance programme
 
Potent drug manufacturing
Facility design for potent drug manufacturing
  • Developing specialised containment solutions for potent drug manufacturing
  • Undertaking a risk assessment of product quality, operator safety and environmental impact
  • Automation systems to reduce operator exposure
 
Contract manufacturing
Inspection of contract manufacturing partners – ensuring quality in external manufacturing operations
  • Developing effective working relationships with external manufacturing partners to allow assessment of their processes
  • Ensuring external manufacturing standards meet in house expectations
  • Overcoming cultural differences in global partnerships
  • Managing the quality across the supply chain when production occurs across multiple sites
 
15:50
Flexible manufacturing - maximising plant utilisation through multi-product production
  • Responding to broader portfolios to overcome revenue losses from patent expiries and generic competition
  • Rigorous but quick cleaning regimens to reduce plant downtime but prevent contamination
  • Utilising closed systems and process automation to prevent cross-contamination
  • Restricting the flow of equipment and personnel in and out of each area – developing module based plants
16:25
Chairman's closing remarks
16:30
Close of conference

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