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PRE-FILLED SYRINGES FORUM 2010
Strategic Development, Inspection, Safety & Regulatory Compliance and Commercialization of Pre-Filled Syringes |
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March 4-5, 2010, Radisson Warwick Hotel, Philadelphia, PA |
Key Learning Objectives:
· Materials, design & construction of pre-filled syringes
· Safety considerations & requirements
· Numerous development case studies
· Manufacturing & filling solutions
· Regulation & inspection of pre-filled syringes
· Future materials for pre-filled syringe components
Including Special Coverage On:
· Syringe Plunger Movement · Stopper Movements
· Development Case Studies · Bubble-Free Filling
· Manufacturing Solutions · Syringe Manufacturing
· Visual Inspection · Extractables & Leachables
· Container Closures · Combination Products
Conference includes several exhibitors and product displays. Contact Kim Hubbard at 217-355-7322 for more information!
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Register by March 1st and receive a $300 discount! |
EXTRACTABLES AND LEACHABLES
Strategies to Ensure Safety and Compliance in the Packaging and Processing of Drugs and Biologics |
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May 3-4, 2010, Radisson Fishermans Wharf, San Francisco, CA |
Featuring Case Studies and Lessons Learned from Industry Experts!
Examine Case Studies and Best Practices for Extractables and Leachables
Manage Extractables and Leachables Resulting from Packaging Materials, Closures and Excipients
Review Toxicology Considerations and Risk Mitigation Strategies
Trace Level Compound Indentification and Extractables and Leachables from Disposable/Single Use Systems
In-Depth Pre-Conference Workshop:
Aligning Safety Assessment and Product Development Activities to Reduce the Risks Associated with Extractables and Leachables: A Case Study Review
Dennis Jenke, Ph.D, Principal Scientist, Physical and Chemical Sciences, Baxter Technology Resources
Featuring Representation From:
Baxter Healthcare Inc.
Baxter Technology Resources
Becton Dickinson
Boehringer Ingelheim Pharmaceuticals, Inc.
Human Genome Sciences
Hyprotek, Inc.
Material Needs Consulting, LLC
Pall Life Sciences
Pfizer, Inc.
Pharmalytica Services
TOXIKON
West Monarch Analytical Laboratories
NOW ACCEPTING POSTER PRESENTATIONS. Please contact khubbard@pharmaedresources.com
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View Brochure I Register
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Register by January 31st and receive a $300 discount! |
QUALITY BY DESIGN (QbD)
A hands-on two day workshop covering the key components of QbD concepts, implementation and product risk mitigation. |
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March 4-5, 2010 - Radisson-Warwick Hotel, Philadelphia, PA |
Key Learning Objectives:
·Understand Risk-Based GMP Compliance and FDA, ICH and ASTM Approaches
·Review Strategies for Defining Risk, Risk Factors and Risk Prioritization
·Understand the Basic Fundamentals and Approach of QbD
·Use QbD to Mitigate Product Risk in Engineering Drug Manufacturing Operations
·Understand the Connection Between QbD and Process Analytical Technology (PAT)
·Implement the Concept of Continuous Improvement
Including Multiple Interactive Exercises and Case Study Examples!
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Testimonials
"This event was the best I've attended in years!"
"Great speakers, great facilitation -- a 10!"
"We look forward to your next event.
It was a very positive learning experience!" |
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