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QbD: QUALITY BY DESIGN
Understanding and Implementing the FDA's
Quality by Design Initiative for the Pharmaceutical Industry |
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May 29 - 30, 2008 - Radisson-Warwick Hotel, Philadelphia, PA |
Case Studies and Lessons Learned from Leading Experts:
· Facilitate Innovation and Continuous Improvement Throughout the Product Lifecycle
· Provide Regulatory Flexibility for Specification Setting and Post-approval Changes
· Streamline the Submission and Review Processes
· Use a Risk-Based Approach to Designing Performance Characteristics for the Operation Used for the Manufacture of Drug Products
· Understand the Regulatory Requirements for QbD
Featuring an In-Depth Pre-Conference Workshop:
IMPLEMENTING A QUALITY BY DESIGN (QBD) APPROACH
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CONTAINMENT OF POTENT COMPOUNDS
Implementing Risked-Based Approaches and Ensure Safety
through Strategic Containment Operations and Processes |
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May 29 - 30, 2008, Radisson-Warwick Hotel, Philadelphia, PA |
Lessons Learned from Leading Industry Experts:
· Understand the Requirements for the Containment of Potent Compounds
· Lessons Learned from the Field: Program Development and Implementation Steps
· Retrofitting Existing Equipment and Facilities to Achieve Requirements
· Defining Design Requirements and Achieving Innovative Design Approaches
· Numerous Industry Case Studies on Design, Implementation and Risk Management
Featuring In-Depth Coverage on:
FLEXIBLE CONTAINMENT SYSTEMS
Installation, Validation and Achieving Compliance
Company Representation Includes:
Genzyme
Floura, LLC
Ash Stevens, Inc.
Powder Systems Ltd.
Astrazeneca
Torres Placa Industrial Corporation
Containment Solutions
Roche Colorado Corporation
Hecht Germany
ILC Dover’s Containment Products
SafeBridge Consultants Inc.
Stantec Consulting Services, Inc.
IES Engineers
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2008 PRE-FILLED SYRINGES FORUM
Strategic Development, Inspection, Safety & Regulatory Compliance and
Commercialization of Pre-Filled Syringes
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June 5 - 6, 2008- Sheraton La Jolla Hotel, La Jolla, CA |
Featuring Case Studies and Lessons Learned!
· Development and Commercialization of a Pre-Filled Product
· Evaluating Proper General Trends for Autoinjectors and Pre-Filled Syringes
· Manufacturing and Outsourcing Strategies of Pre-Filled Syringes
· Examining Potential Interaction Between Pre-Filled Syringes and Biopharmaceutical
Products
· Inspecting Pre-Filled Syringes for Both Particulate Matter and for Cosmetic Defects
· Syringe Plunger Movement During Air Shipments
· Suitability for Intended Use Considerations for Pre-filled Syringe Systems
......And much more
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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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