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Interphex2007 Pharmaceutical,
Biotechnology, Healthcare Conference
April 24 - 26, 2007
Jacob K. Javits Convention Center, New
York, NY
M29: Regulatory Compliance & Operational Excellence Workshop
Thursday, April 26, 2007 // 9:00AM - 12:30PM
Topic # 1: Regulatory Compliance and Business Excellence Lessons Learned
Workshop Chairman and Seminar Speaker: Costas Chantzis, President of TechnoBusiness Solutions
This seminar will teach the attendees how to identify and remediate the root cause of “low hanging fruit” yet systemic regulatory compliance and business excellence issues by engaging them in tested and proven problem resolution methods through actual case studies.
• Specification of Incoming Materials/Components
o Bubbles and silica’s thickening value property
o Powder’s particle size distribution and dissolution rate
• Supplier’s Quality Control
o Pellet contamination and intermittent extrusion/molding product failures
o Membrane/filter composite manufacturing and sporadic product failure in the hospital
• Equipment Operational Boundaries and Parameters
o The bio-reactor has no critical process parameters since it is a stable operation within its current operating conditions
o The thermoformer’s processing speed and product quality output are highly dependent on the mechanic that set-up this equipment and not on the already validated critical process parameters; setting the equipment blindly to those parameters has caused us lots of problems in the past
• PAT and Failure to Understand the Manufacturing Process
o Surfactant and black specs in the curing oven
o Product lot failures, humidity and process start-up after a manufacturing plant holiday or off day
o Lumps in viscous liquid, screens, homogeneity and product potency
o Molded part has intermittently either micro-cracks or stress/discoloration at the same two locations but everything is in spec.
o Cells of the blister package are boarder-line thin at the bottom especially at start-up
• Completed Failure Investigations w/o Proper Remediation
o Root cause unknown, corrective action not completed but investigation successfully closed
o Repetitive and identical product test failure symptoms w/o escalation to Significant Investigation, etc.
o Foreign finds, lack of components’ reconciliation while various manufacturing processes were producing salable product
o Two thermocouple failures in lyophilizer but equipment continued to manufacture salable product for 1.5 years w/o remediation of the failures.
Topic # 2: Case Studies on How-To Troubleshoot Quickly and Correctly Your Material and/or Process Problems With Analytical Laboratory Expertise/Know-How.
Speaker: John Donohue, Director, Analytical Laboratory Services of TechnoBusiness Solutions
The seminar will present Case Studies of Analytical Methodologies that identified the cause and resolved the problem with a CERTAIN fix, assuring non-recurrence of the problem.
• Results of material and/or process induced failures can include:
o FDA Warnings, 483’s, Consent Decree, etc.
o Product recalls
o Factory shutdowns
o Litigation issues
o Customer complaints
• Resolution of such regulatory compliance of business issues typically requires (i) an assurance that the problem has been solved with a high level of certainty and (ii) both technical knowledge of the material and/or process, and the analytical prowess to know where to look for the Root Cause.
• Problems caused by the Package-Forming Process:
o Nerve gas antidote injector pen barrels were splitting upon ejection from mold. Stress Birefringence Analysis identified the cause and suggested the process changes required for its solution.
• Problems caused by the Sterilization Process:
o Drug delivery systems and packages were undergoing a deterioration of their resistance to breakage as they aged in warehouses. FTIR showed that the cause was the continuing free radical oxidation of the polymer. Proper stabilization to these reactions eliminated most of the oxidation and embrittlement.
• Problems caused by the Material or Material-Process Interaction:
o Bioresorbable arterial implants were being injection molded with bubbles in the product. The synergistic use of FTIR Microscopy, GC/MS, and knowledge of polymer's chemistry proved the cause and assured its non-recurrence.
• Problems caused by Material Suppliers' Errors:
o Plastic, fluid delivery systems were being molded with wrinkled walls and a $100MM/yr factory was about to shutdown. The development of a method for the rapid chemical analysis of large numbers of the supplier's polymer pellets and statistical analysis of the resulting data proved two different populations of pellets with different rates of solidification were inadvertently mixed together causing this problem. A new incoming inspection assured this problem would not recur.
Topic # 3: Data-Driven Methods for Regulatory Compliance and Business Excellence
Speaker: Cliff Campbell, President of CampbellInformatics
Key drivers within 21st century pharmaceutical engineering include:
• Optimized “facilities & equipment” compliance
• Reduced technical errors
• Elimination of unwanted variability
• Reduced costs and timelines
• Lifecycle integration/unification
• Efficiency of data exchange
• Right-First-Time
• Quality-by-Design
In response to the above, the seminar will introduce a data-driven approach to quality engineering, with “documented evidence of compliance” treated as a consequence of good engineering practice, aided and abetted by 21st century modeling techniques.
Using a number of industry and regulatory standards/benchmarks drawn from FDA, ASTM and ISA, the seminar will teach attendees how the Requirements: Design: Test elements of the standard lifecycle can be unified into an integrated whole, eliminating the notorious disconnects associated with the traditional V-model.
Following a conceptual introduction, the seminar will concentrate on case study material, relying heavily on audience participation.
Topic # 4: Case Study - Improving Manufacturing Performance & Cycle Time at DuPont Pharmaceuticals
Speaker: Tom Knight, Chairman and CSO of Invistics
The DuPont Pharmaceutical Company reshaped its organization and systems to improve manufacturing performance and dramatically cut cycle time. This case study presentation will summarize the organization changes and information systems that were implemented. It will concentrate on the Lean and Six Sigma techniques that have cut cycle time and streamlined product flow.
The presentation will give the audience an overview of the techniques and tools used by DuPont Pharmaceuticals to reduce cycle times 50% and lower inventory by $10 million.
These techniques include:
- Organizing products into process-based "Flow Paths"
- Organizing people and support staff into process-based "Focused Factories".
- Changing performance measures to motivate shop floor change and cycle time reductions.
- Implementing Pull scheduling techniques using Constant Work-In Progress (CONWIP).
- Developing an Intranet site that promotes Lean principles and overcomes the weaknesses of Enterprise Resource Planning (ERP).
- Optimizing inventory levels and capacity buffers to minimize inventory and cycle time while maximizing throughput and customer service.
The talk will also present the lessons learned from this case study, including:
- How to apply Lean concepts in a high mix, low volume manufacturing environment
- How to reduce cycle time by 50% or more in a high-mix, low volume manufacturing environment
- How to leverage existing IT investments to improve manufacturing performance
- How to motivate organization change to reach improved cycle time, throughput, and delivery performance.
Attendees will learn:
How to reduce cycle time by 50% or more in a high-mix manufacturing environment.
How to leverage existing IT investments to improve manufacturing performance.
How to motivate organization change to reduce cycle time.
How to implement pull scheduling in a high-mix, low volume environment.
How to optimize inventory levels and capacity buffers in the face of variability.
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