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
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