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2019 - ASTM 2500: Lessons Learned Through a Decade of Implementation
Date2019-02-04
Deadline2019-02-04
VenuePalo Alto, USA - United States 
KeywordsAstm 2500 standard guideline; Astm e 2500 validation method; Astm 2500 implementation
Topics/Call fo Papers
Regulatory Requirements for a Compliant Validation Program
FDA
EU
ICH Q7
ICH Q8: Pharmaceutical Development
ICH Q9: Quality Risk Management
Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach
What is ASTM 2500
Definition
Concept
Requirements
Differences from traditional validation approach
Real World Examples of ASTM 2500 Implementation
Lessons Learned
FDA
EU
ICH Q7
ICH Q8: Pharmaceutical Development
ICH Q9: Quality Risk Management
Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach
What is ASTM 2500
Definition
Concept
Requirements
Differences from traditional validation approach
Real World Examples of ASTM 2500 Implementation
Lessons Learned
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Last modified: 2019-01-03 15:54:24