2012 Conference Program
Program - Day One
Challenges, Opportunities, and Choices Facing Pharmaceutical Manufacturers in an Age of Transition
- Offering insights into the internal and external forces impacting the pharmaceutical manufacturing community
- Revealing and reviewing emerging trends in strategic decision-making as the industry transforms itself
- How are emerging markets shaping the future of pharma manufacturing? What role will establishing markets continue to play?
- Where does manufacturing excellence and quality management fit into the new trajectory of pharmaceutical companies? What more still needs to be done?
Michael Kamarck
President, Merck BioVentures & Senior Vice President, Vaccines and Biologics Manufacturing
Merck
The 2011 Facility of the Year Awards Overall Winner
- Outlining the decision-making process that led to the creation of a flexible, large-scale mammalian cell culture-based production facility
- Highlighting some of the planning, implementation, and training programs that built and validated a new plant on an aggressive timetable
- Illustrating the contributions state-of-the-art automation and a fully-integrated Process Control System (PCS) offer to plant operations
- Discussing how this facility’s versatility fits into the changing realities of pharmaceutical manufacturing
Lessons Learned from an Industry-wide Study on What Works, What Doesn't, and Why
- Illustrating the trends discovered during a study of 160 pharma manufacturing plants from 2004 to 2011: Where are outsourcing, lean programs, Continuous Improvement, OpEx, and other initiatives consistently failing to meet their goals?
- Moving beyond 'Reduction of Complexity' as the final goal to better understand and control the unreducible complexities inherent in global pharmaceutical manufacturing
- Highlighting the importance of a management and workforce cultural shift towards continuous improvement as the key to success in all improvement initiatives
Technology Transfer: Bridging Process Development and Manufacturing
Led by Aegis Analytical Corp
- Ensuring fast progression of pre-manufacturing processes through clinical trials, regulatory submissions, and start-up of full-scale commercial operations
- Understanding how enabling technology can achieve the goals of "Quality by Design" and "Design for Manufacturing"
- Outlining how interactive access to all the data types (continuous, replicate, discrete, events, keywords, text) from all data sources can improve manufacturing outcomes
Meeting Regulatory and Compliance Requirements in Your Operation's Manufacturing Processes
Led by Compliance Insight
- Anticipating what FDA inspections are seeking through conducting your own internal inspections
- Offering key steps and best practices to improve your validation program
- Ensuring timely approval of FDA submissions: What does the extra mile look like?
Overcoming Operational and Logistical Challenges of Maintaining an Uninterrupted Finished Goods Supply During Product Transfers and Plant Closures
Led by Ropack
- Offering key practices to maintain an uninterrupted supply chain in a changing environment
- Controlling transition periods: Planning, data collection, and implementation policies that reduce risk and prevent scope creep
- Working with partner organizations: Real-world examples of communication and clear areas of responsibility producing positive outcomes on time and on budget
Demonstrating how progressive pharmaceutical companies are finding shelter within their own factories
- Discussing the austere “New Normal” in the economy and what it means for pharmaceutical manufacturers in 2012
- Illustrating how “Old Normal” technology solutions are missing the target
- Offering workforce “back to basics” – the old/new approach to igniting workplace productivity
CASE STUDY: Operational Excellence: Learning from Successful Operations
How Lessons Learned from Baxter’s 2008 Shingo Award-Winning Facility are Contributing to Enhance OpEx Initiatives in Other Locations
- Highlighting some of the programming that led the manufacturing plant in Cartago, Costa Rica to win the 2008 Shingo Award for Operational Excellence
- Discussing some of the universal challenges of pharmaceutical manufacturing. Of the solutions, which are based on tools and which are based on people? Which are required to assure sustainability in the long term?
- Applying best practices and lessons learned at the Cartago plant to other operations: What can be replicated and what will require its own personality?
Consolidation of QbD and PAT into a Real-Time Continuous Process
- Illustrating how QbD and PAT reinforce one another
- Developing risk- and science-based real-time process controls
- Demonstrating parameters and critical points in pharma manufacturing
Qualifying and Establishing a Network of Vendors for Manufacturing Services
- Identifying the key capabilities and best practices your organization requires of a potential partner
- Evaluating strategies to identify, evaluate and secure vendors in the clinical supply manufacturing space
- Creating cost-savings and improving reliability through the development of an effective network of vetted and qualified partner organizations
Bernard Huyghe
Senior Director, External Supply - Pharmaceutical Sciences, Biotherapeutics & Vaccines Outsourcing
Pfizer
Integrating Change Management Practices into Business Excellence Programs
- Developing an appreciation for the “people” pieces of projects
- Incorporating change management tools into business excellence programs
- Understanding the importance of timing around change management training
- Helping staff understand their roles and responsibilities to ensure the success of a project
Achieving Success in Technology Transfers
- Offering best practices in tech transfer from lab to pilot and from pilot to commercial production
- Opening up lines of communication between all stakeholders
- Avoiding costly delays through a continuous transfer of knowledge and technology
- Defining and confirming success before, during, and after a transfer
Dr. Lamar Alani
Vice President Pharmaceutical Products and Technology Development
Alcon Laboratories
Protecting your IP internally and externally: Key tools and tactics that secure your information without impacting your productivity
- Reducing risk through identifying the strengths and weaknesses of your potential business partner
- Developing a clear understanding of what both parties require to ensure long-term mutually beneficial success
- Monitoring and contributing towards your partner’s performance
Continuous Manufacturing in Pharma: Making Fully Integrated Systems a Reality
Technologies, Operational Impacts, Trends & Drivers
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- Addressing the benefits of continuous processes and the importance of investing
- What facility designs and upgrades are needed for the successful deployment of continuous manufacturing?
- Updates on patent filing - FDA support in various scenarios
- Discussing how QA/QC are impacted by continuous manufacturing
- Offering a data-driven case study of continuous manufacturing in action
CASE STUDY: Risk-MaPP Applied to Real-World Operations
Implementing ISPE Risk-Based Manufacturing of Pharmaceutical Products to comply with ICH Q9 Guidelines
- Highlighting Teva's experience across a number of different facilities in Canada
- Discussing the challenges and obstacles faced by assessment teams
- Demonstrating the decision-making process while revising existing practices like cleaning validation and gowning
- Monitoring and maintaining risk-based processes moving forward
Operational Excellence for Pharmaceutical Manufacturers
- Organizing roles an operation to ensure a sustainable cultural transformation
- Building relationships between the principles, systems, tools, and participants of OpEx
- Highlighting examples of OpEx working in case studies from around the world
Best Practices in QA/QC to Meet ICH Q8, Q9, and Q10 Guidelines
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- Evaluating the contributions of QbD, Risk-MaPP, and other structured approaches to quality management
- Anticipating the requirements of regulatory agencies: Opportunities to improve documentation, validation, and internal auditing and inspections to drive QA and reduce liability
- Reviewing solutions to universal industry challenges based on real-world examples
Program - Day Two
- Understanding how leading companies are breaking typical operations' paradigms
- Driving change beyond historical organizational and functional boundaries
- Highlighting examples of specific initiatives showing how companies have taken on these challenges
CASE STUDY: Working with the Brazilian Government to Build Strong and Successful Operations in a Rapidly Growing Economy
- Offering key takeaways to creating and maintaining good relationships with local regulators
- Debating the pros and cons of operating in Brazil directly versus outsourcing to contract manufacturing organizations
- Highlighting examples of successful product launches and clinical trials in Brazil: What are the common best practices?
- What does the future hold for pharmaceutical manufacturing in Brazil?
- Offering sourcing strategies to enhance supply chain security
- Creating robust systems to provide feedback on supply chain health and risk
- Using continuous improvements along the supply chain to generate and improve cost recovery
Analytical Considerations in Manufacturing Process Validation
Working Solutions to Take QbD from Concept to Reality
Pharma Disruptors - Implications for Outsourcing & Supply Chain
Cost of Goods Reduction: Controlling Expenditure & Maximizing Efficiency
- Offering new approaches to controlling costs throughout the manufacturing process
- Illustrating the positive impact efficiencies and improved methodology has had on drug development and manufacturing
- Discussing best practices and lessons learned in real-world situations. What are the key takeaways?
Creating the Facility of the Future
- Imagining a flexible, more-efficient production center
- Illustrating how new technologies impact facility design
- Comparing some of the current options available to pharma manufacturers
- Developing decision-making tools for long-term production planning
Maximizing the Mutual Benefits of a Business Relationship Through Information Sharing
- Creating transparency between your organization and its contractors, suppliers, and vendors
- Connecting MRP, quality, and lab management systems together to enhance accountability, drive performance, and build win-win outcomes
- Eliminating redundancies through the pools of resources with your partners
- Debating the pros and cons of formally defining open communications in contractual agreements
Preparing and Empowering Laboratories for Sustained Growth
Led by Waters
- How can new technologies be utilized to meet increased demand by customers?
- Developing a growth strategy for your laboratories based upon increased efficiencies
- Maintaining consistent and compliant workflows while expanding capacity
GMP Vendor Oversight: Compliance Strategies
Led by CIS
- Creating an effective audit plan
- Understanding the pros and cons of global versus domestic auditors
- Developing risk-based compliance
- Risk evaluation and developing a post-quality plan
Exploring the Latest Advancements in Clean Air Solutions for the Pharmaceutical Industry
Led by Camfil Farr
- Detailing the atmospheric requirements of pharma manufacturers
- Discussing options in air filtration and dust collection systems
- Evaluating life cycle costs, energy conservation options, and total cost of ownership analysis for air cleaning assets
- Offering real examples from large pharmaceutical plants
- Discussing whether the pharma industry can build a solid emerging market supply chain and cater to people in developing markets
- Analyzing the experience of companies like DELL, which have developed world class supply chains for their products. What were their solutions to universal challenges?
- Exploring opportunities to manage global supply chains to achieve significant reductions in overall operating cost while also accelerating time to market
Maximizing Positive Outcomes Through Manufacturing Compliance and Quality
- Discussing the role of leadership in the implementation of a continuous improvement program
- Developing and engaging the workforce
- Illustrating tools, tactics, techniques, and technologies that make a positive impact
- Highlighting examples of specific initiatives at a number of manufacturing sites: What worked? What failed? What separated the former from the latter?
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