UPCOMING WEBCASTS  Monday, June 30, 2008
11am - 12pm ET
Risk Management in the Pharmaceutical Industry
Lou Angelucci, Associate Director of Quality Assurance Bristol-Meyers Squibb Pharmaceutical
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In today´s environment and with the advent of the Pharmaceutical Quality in the 21th Century initiative by the FDA as well as the implementation and application of CAPA systems in the Pharmaceutical and Medical Device Industries, Risk and Risk assessment are playing more critical roles in today?s qualification and production environments. This presentation will be an overview of the application of Risk management to Quality Systems, validation and CAPA initiatives. The key aspects of ICH Q9 will be covered as well. With this presentation an example formula used by many to evaluate risk as an attempt to quantify risk will be presented. Other application examples from industry will also be presented.
Thursday, July 10, 2008
12pm - 1pm ET
ASTM E2500 Consensus Standard: An Overview of a New Approach to Validation
Gamal Amer,Ph. D. Principal at Premier Compliance Services, Inc.
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Thursday, July 22, 2008
11am - 12pm ET
Learning from Recent FDA Warning Letters Related to Computer Validation and Part 11: With Clear Recommendations for Corrective and Preventive Actions
Dr. Ludwig Huber, Agilent Technologies.
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The new Part 11 regulation takes quite some time, but inspectors go out and focus inspections on computer systems and electronic-records for compliance with GMPs. Just in 2007/2008, there have more than 20 deviations related to computer system validation and Part 11compliance, some with disastrous consequences for inspected companies. Attend the seminar and learn how to avoid such warning letters.
Tuesday, August 19, 2008
11am – 12 pm ET
Case studies in Quality by Design, QbD, with Design of Experiments, DOE, from Journal Articles Published in Pharmaceutical Technology
Mr. Lynn D. Torbeck,
Principal Consultant, Torbeck and Assoc., Inc.
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 Tuesday September 9, 2008
2pm – 3pm ET
Recent Trends In The Development And Manufacturing Of Fusion Proteins As Therapeutics
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Fusion genes are created by joining two or more genes, each coding for a separate protein. Translation of the fusion genes results in a single polypeptide with the combined functional properties of the original proteins. Recombinant fusion proteins are created artificially by recombinant DNA technology for use in biological research or therapeutics. To participate in an active webcast about recent trends go to:
ARCHIVED WEBCASTS Enhancing Tech Transfer from Development into cGMP Operations
Sponsored By Laureate Pharma
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Available through April 28, 2009 Beyond Theory: How to Implement Changes to USP Chapter <467> Residual Solvents
Tuesday, April 22, 2008
Sponsored by Celsis
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Available through April 22, 2009 |
For questions or more information please contact Jamie Carpenter at
jcarpenter@advanstar.com or call 800-234-4535 |
