2021 - Laboratory Inspection and Auditing

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
Sampling
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
Contents/topics
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
Development
Validation
Transfer
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