10:00 AM - 03:00 PM
DAY 1

Lecture 1 :
- Requirements and approaches for Analytical Instrument Qualification
- Going through the qualification phases

Lecture 2 :
- Testing and deviation handling
- Retrospective qualification and Requalification

Lecture 3 :
- Equipment Maintenance and Change control
- Type and extend of qualification for USP Instrument Categories

Lecture 4 :
- Requirements and approaches for Laboratory Computer Systems
- Examples for risk assessment of computer systems

10:00 AM - 03:00 PM
DAY 2

Lecture 5 :
- Validation of Laboratory Computer systems
- Preparing inspection ready validation documentation

Lecture 6 :
- Validation and Use of Excel in the QC Laboratory
- How to ensure spreadsheet and data integrity

Lecture 7 :
- Periodic review and revalidation of chromatographic data system
- Handling raw data and other laboratory records
- Ensuring Integrity and Security of Laboratory (Raw) data

Lecture 8 :
- Auditing Laboratory Computer Systems and records for FDA Compliance
- Learn how to avoid or respond to FDA 483s and warning letters