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2021 - Laboratory Inspection and Auditing



Venue, USA - United States USA - United States

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


Topics/Call fo Papers

Day 01(10:00 AM - 5:00 PM EDT)
10:00 AM -11:00 AM
GMP regulations for quality control operations
US 21 CFR 211, 21 CFR 11
Key EU GMP chapters and annexes
GMP controls over the analytical process
Sample preparation and analysis
Results calculation and reporting
11:00 AM -11:15 AM Break
11:15 AM -1:15 PM
Commonly-used analytical techniques
Wet chemical methods
Instrumental methods
Pharmacopoeias and ICH
Regulatory status
Control of standards, reagents and consumables
Reference standards types/acceptability
Control of reagents
Critical consumables (e.g. chromatography columns)
1:15 PM -1:45 PM Lunch
1:45 PM -3:15 PM
Lifecycle managements of analytical methods
Verification of compendial methods
System suitability tests
Post-approval changes
Analytical instrument qualification
Classification of analytical instruments
Risk-based qualification
3:15 PM - 3:30 PM Break
3:30 PM - 4:30 PM
Data integrity
Overview of regulatory guidance
Data governance policy
Control of electronic data systems
Stability studies
Storage conditions
Managing excursions
Requirements for reference and retention samples

Last modified: 2021-07-19 04:26:32