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Validation and Qualification
in Analytical Laboratories
CGXP-10
CD-based training program
A convenient and efficient training and reference guide
accessible at any time at your desk, the CD comprises:
- Useful documents
for easy and convenient implementation: SOPs/Templates/Examples/Gap
Analyses/Checklists.
- FDA Regulations
and guidelines related to Good Lab/Manufacturing Practices,
equipment qualification, method validation and 21 CFR
Part 11. These predicate rules help to understand FDA's
current thinking. Includes guidelines specific to analytical
laboratories.
- FDA Warning
Letters/Establishment Inspection Reports (EIR) and/or
483 inspectional observations related to laboratory
procedures and equipment - with keywords for easy searching.
Learn from and avoid the mistakes others have made.
- Documents from
agencies in Europe related to equipment qualification
Validation
of Computerized Analytical and Networked Systems
CGXP-20
CD-based training program
A comprehensive collection of valuable resources provide
easy self-paced learning: - Introductory overview -
Standard Operating Procedures - Gap Analyses and Checklists
- FDA 'Predicate Rules' - Templates and Examples -
FDA Guidelines on Computer Validation - FDA Warning
Letters, Establishment Inspection Reports - EU GMP
Directives - ICH and NIST Guidelines
FDA
Inspections - Best Practices
CGXP-30
CD-based training program
This primer provides an excellent understanding of
FDA regulations, inspection practices, the consequences
of deviations, and how to respond to warning letters.
- FDA Regulations and Guidelines - Making the Best
out of FDA Inspections - Preparing for FDA Compliance
- Sequential FDA Actions for non-compliance - Example
SOPs - Real Enforcement Examples - FDA Regulations
and Guidelines - FDA Warning Letters and Inspection
Observations - Science and Risk-based Inspection Approaches
Includes SOPs for: - Risk assessment, people qualification/training
and change control - Preparation, conduct and follow
up of FDA inspections - Laboratory failure investigation
- Qualification of Equipment
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