2021 - Recordkeeping and Documentation in a GLP Laboratory (US FDA, US EPA and OSHA Focus)

Day 01(9:30 AM to 5:30 PM EST)
Session 1 (90 Mins)
Recordkeeping and Archiving – Who, what, when, where, why, and how these are performed – an Overview.
Session 2 (90 Mins)
Who is responsible – what are the roles?
Session 3 (90 Mins)
What things must be recorded and archived?
Why is this important? The Role of Records and Documents in Compliance and Operations
Session 4 (90 Mins)
Where are specific things recorded and archived?
The How to keep records, the Logging System, Offsite versus Onsite Archiving.
Day 02(9:30 AM to 5:30 PM EST)
Session 5 (90 Mins)
Basic laboratory operations - Facilities maintenance records
Sample entrance and records, Sample handling and storage, Chain of custody
Session 6 (90 Mins)
Sample preparation records
Weighing, volumetric glassware, labeling
Sample solution handling and records
Session 7 (90 Mins)
Stability testing! Logbooks for preparation of standards, reagents, and buffers.
Instrument repair and maintenance logbooks, calibration logbooks
Session 8 (90 Mins)
Prevention through the Use of Control Charts, Nelson's Rules as a Statistical Basic for such Monitoring
Troubleshooting and Prevention Efforts
Safety as a Compliance Issue