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| Contact |
IPA Canada:
International Pharmaceutical Academy
420 Highway #7 East, Box 82022
Richmond Hill, Ontario
Canada L4B 3K0
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| Description |
Program Highlights
Introduction/Quality Systems
Regulatory Requirements and FDA Directives
ICH Q7,Q2(R1) and other Guidelines
USP <1058> Qualification
Measurement Resolution and Errors
Calibration Standardization and Validation
Calibration Master Doc
Calibration Management
Laboratory Systems
Product Lifecycle Concept
Responsibilities of Vendors and Users
IQ/OQ/PQ and PM
Validation and Qualification Strategies; Risk Assessment Approach
ICH Q9/ SO/ASTM guidance
Documentation Strategies; Master Validation Plan and Protocols
Development of Protocol (Case Study)
Examples of OQ and PQ
Examples of OQ, PQ: Some Select Protocols
HPLC Systems
Dissolution Apparatus
TOC, LC-MS and others
PQ vs. System Suitability
Training Requirements
Group Exercise
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