2012 Conference Program
Program - Day One
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
Maximizing Positive Outcomes Through Manufacturing Compliance and Quality
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- 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?
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
Research Findings from Aberdeen Research and a Practical Roadmap for Success
- What targeted Continuous Improvement is worth if sustained
- The practical realities for mid-sized companies embarking on the Continuous Improvement journey
- The communications barrier & how it can kill success
- How workforce development & a technology framework combined can deliver improvement results at pace
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?
Working Solutions to Take QbD from Concept to Reality
- Making Quality by Design a part of early decision-making during product development
- Anticipating and avoiding common challenges during technology transfer
- Improving process robustness : QbD as a positive force in commercial production
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
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
Electronic Enterprise Quality Management Systems: Protecting Customers, Maintaining Compliance, and Positively Impacting the Bottom Line
Led by Sparta Systems
- For too long Quality Assurance has been viewed as a cost center and a necessary evil in the life sciences marketplace: Quality processes have been siloed in disconnected systems with little management visibility and oversight of issues. In this session delegates will:
- Explore bringing related processes together on a global basis
- Integrate systems to create transparency and effective and timely decision-making
- Examine how improved quality creates not only safer products, but also creating efficiencies and measurable cost savings
Exploring the Latest Advancements in Clean Air Solutions for the Pharmaceutical Industry
Led by Camfil Farr Air Pollution Control (APC)
- 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
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
CASE STUDY: A Practical Approach to Implementing ICH Q10 – Pharmaceutical Quality Systems
- Quality Objectives and Key Performance Indicators: Applying process performance metrics to the planning and implementation of PQS
- Continuous Improvement Plan/Report: leveraging Quality groups’ goals to monitor and sustain continuous, targeted improvement
- Management Review: Quality reporting structure and building a quality-minded culture
- Best practices and lessons learned: Making the theory work in a real-world setting
- Internal partners’ education: Others must know why…Quality is not just a nuisance
- Industry-driven Quality principles: Becoming industry leaders again
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. Laman Alani
Vice President Pharmaceutical Products and Technology Development
Alcon Laboratories
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
- The business drivers for how we manufacture vaccines in the future
- The role of process and analytical development in transforming the future manufacturing
- Evolution towards mechanistic understanding
- Manufacturing flexibility and strategy for lifecycle management
- Innovation and its ability to bring transformational change
Parimal R. Desai, Ph.D.
Executive Director, Vaccines Manufacturing Science and Commercialization
Merck
- Understanding the global operating environment from an IP and wider regulatory perspective
- Highlighting countries and regulators with the best and worst enforcement of IP protection laws
- Protecting your IP internally and externally: Key tools and tactics that secure your information without impacting your productivity
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?
Line Performance Optimization: A Focused Approach for Improving Output, Reducing Cost and Ensuring Compliance
Led by Life Cycle Engineering, Inc.
- Applying select reliability engineering and lean tools to solve chronic performance issues
- Creating value stream maps necessary to focus problem solving
- Performing failure analysis to identify equipment and operating risk
- Developing proactive control strategies to mitigate failure modes
- Leveraging Change Management methods and tools to engage employees and ensure sustainability
- Implementing visual management and develop key reporting metrics to drive the right behaviors
Collaborative Communication Platforms Maximize Production Control, Analysis and Productivity
Led by COPA-DATA USA Corp.
- Creating a collaborative production environment that communicates with business IT
- Moving your production models from individual machines to holistic processes
- Enabling existing infrastructure for the next generation of pharmaceutical production
- Monitoring, documenting, and electronically archiving performance and production data
Pharmaceutical Labelling: Clear, Concise, and Correct the First Time, Every Time
Led by Global Visions Inc.
- Reviewing real-world pharmaceutical labeling errors. Why did they occur?
- Discussing different technologies available in printing, labeling, and proofing
- Walking through workflow and artwork management solutions
- Highlighting Business best practices that secure the end to end
Luncheon Led By Tata Consulting Services
Supply Chain Challenges and Strategy for Serialization
Luncheon Led By Kepner-Tregoe
Topic to Be Announced
Luncheon Led By Mar Cor Purification
Topic to Be Announced
Luncheon Led By Metrics Inc.
Topic to Be Announced
Using New Communications Tools to Balance Supply and Demand Decisions in Pharmaceutical Manufacturing Supply Chains
Led by Kinaxis
- Integrating supply chain management and sales and operations planning functions together through a cloud solution
- Bringing stakeholders from every link of the supply chain together to pool information, share resources, and respond in real-time to emerging challenges
- Demonstrating the new tools in action based upon real-world case studies
GMP Vendor Oversight: Compliance Strategies
- 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
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
The Small and Virtual Company Perspective in Contract Manufacturing
- Identifying the best CMO for your production requirements
- Negotiating a mutually agreeable and beneficial business relationship
- Establishing the roles and responsibilities of all stakeholders
- Creating a mechanism for oversight and open communication
- Cultivating a collaborative culture that works towards shared goals
CASE STUDY: Successfully Implementing Manufacturing Execution Systems
Successfully Implementing Manufacturing Execution Systems
- An overview of Janssen Supply Chains fully integrated MES solution, currently being deployed across the network. One of the primary objectives is to implement a paperless manufacturing environment, using MES in combination with enterprise historian and other key systems. The presentation will focus on how Janssen has achieved their goals and also look at the data that is enabling them to move to full review by exception and automatic release. Issues to be discussed will include:
- Easily developing and maintaining manufacturing processes
- Deploying systems to allow for manufacturing to be executed in a paperless production environment
- Ensuring flawless process control in high-risk environments
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
Strategies to Build Versatility and Security into Supply Chains
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- Identifying and mitigating potential bottlenecks in the supply chain
- Creating a feedback system based on metrics to monitor supply chain health and performance
- Improving manufacturing capacity by aligning supply chain factors with demand management and forecasting
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