09:00 AM - 03:00 PM

Lecture 1:
- Recordkeeping and Archiving – Who, what, when, where, why, and how these are performed – an Overview.

Lecture 2:
- Who is responsible – what are the roles?

Lecture 3:
- What things must be recorded and archived?
- Why is this important? The Role of Records and Documents in Compliance and Operations

Lecture 4:
- Where are specific things recorded and archived?
- The How to keep records, the Logging System, Offsite versus Onsite Archiving.

09:00 AM - 03:00 PM
Day 2

Lecture 5:
- Basic laboratory operations - Facilities maintenance records
- Sample entrance and records, Sample handling and storage, Chain of custody

Lecture 6:
- Sample preparation records
- Weighing, volumetric glassware, labeling
- Sample solution handling and records

Lecture 7:
- Stability testing! Logbooks for preparation of standards, reagents, and buffers.
- Instrument repair and maintenance logbooks, calibration logbooks

Lecture 8:
- 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