GLP Bioanalysis 2005 will lead you through the
complicated task of establishing and operating a lab according to GLP
guidelines. Pitfalls, challenges and solutions will be discussed as well as
specific case studies presented. Experts from the pharmaceutical industry as
well as consultants will provide “step by step” guidance and analysis of
common errors and how to avoid them.
LEARN:
- The
difference between qualification and validation
- Method
validation for Biomarkers
- How
to write SOP's and how to select LIMS for GLP
- How
to be prepared for the audit
It’s complicated - but it can be done!
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Featured
Presentation
Regulatory Compliant Research: An Interdisciplinary Approach
Mr. Patrick DeVillier, Director,
Compliance, A.P. Pharma, Inc.
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APPROACHES
TO Method QUALIFICATION & Validation
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Regulatory Compliant Research: An Interdisciplinary Approach
GLP-Like: Taking GLP Processes to your Lab with Ease
Bioanalytical Method Qualification versus Validation: A Regulatory Clarification
Validation of Automated Methods for Bioanalytical Testing and Biomarker
Discovery
The ELISPOT Evolution- from Pilot Experiment to GLP- Compliant Work Flow
Limitations of the Current Bioanalytical Guidance Document
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dOCUMENTATION
AND 21 CFR 11
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How to Write Effective SOPs
Image Compression and 21 CFR Part 11 Compliance
Mitigating Validation of a Bioanalytical LIMS System
Panel: Implementation Experiences Creating a GLP Image Analysis
Workstream:
Qualifying
from Capture to Final Storage
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Quality Assurance and the GLP Audit
Sponsors, Monitors and Contract Research Organizations
Preparing for Internal and External Audits
Panel:
GLP Compliance Problems and Compliance Solutions
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Speaking
opportunities still available!
Contact Margit Eder,
781-972-5478, meder@healthtech.com
For sponsorship and exhibit information, please contact:
Carol Dinerstein, Manager of Business Development
Phone: 781-972-5471 • E-mail: dinerstein@healthtech.com
