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2020 - Laboratory Inspection and Auditing



VenuePhiladelphia, PA, USA - United States USA - United States

KeywordsLab safety audit checklist; Quality control of drugs; Laboratory inspection


Topics/Call fo Papers

US and EU GMPs relating to quality control operations
Appropriate GMP controls at each step in the analytical process
Information provided by different analytical techniques
Pharmacopoeias – contents, structure and regulatory significance
Significance of ICH guidance
Quality requirements for reference standards and reagents
What are critical consumables and how should they be controlled?
Control of analytical methods over their lifecycle
Appropriate qualification of analytical instruments
Data integrity – current expectations
Control of stability studies
Requirements for reference and retention samples

Last modified: 2020-04-04 00:14:01