2021 - Analytical Instrument Qualification and System Validation

Day 01(10:00 AM - 5:00 PM EDT)
10.00 AM - 10.45 AM - Requirements and approaches for Analytical Instrument Qualification
FDA/EU, PIC/S requirements
Qualification/calibration issues in FDA inspections
USP General Chapter <1058>: Analytical Instrument Qualification
The instrument qualification lifecycle
Prioritizing calibration/qualification activities
10.45 AM - 11.30 AM - Qualification in Practice
User requirement specifications
Installation qualification
Operational qualification
Preparing inspection-ready documentation
11:30 AM - 11:45 AM - Break
11.45 AM - 12.45 PM - Testing and deviation handling
Developing test protocols
Documenting test evidence
Review and approval of test results
Handling deviations
12:45 PM - 1:15 PM - Lunch
1.15 PM - 2.30 PM - Retrospective qualification and Requalification
Qualification of existing systems
Leveraging past experience
Time-based requalification
Event-based requalification
What and how much to test – risk-based approach
2.30 PM - 3.15 PM - Equipment Maintenance and Change control
Preventive maintenance; tasks, documentation
Planned and unplanned changes
Changing hardware, firmware, documentation
Definition and handling of like-for-like changes.
Handling changes made by vendors
3.15 PM - 4.00 PM: Type and extend of qualification for USP Instrument Categories
The approach and benefits of instrument categories
How to identify the correct category: A, B, C
Type and extent of qualification for each category
Required procedures and qualification deliverables
Responsibilities for instrument qualification
4:00 PM - 4:15 PM - Break
4.15 PM - 5.00 PM - Requirements and approaches for GMP Computer Systems
21 CFR Part 211, Part 11, PIC/S, EU Annex 11
Most critical inspection findings
Which systems need to be validated
GAMP 5: A Risk based Approach to Laboratory Computerized Systems
Examples for risk assessment of computer systems
Validation of Laboratory Computer systems
Writing a validation project plan
Integrating GAMP 5 with USP <1058> for instrument and computer system validation
Writing a validation report
Day 02(10:00 AM - 5:00 PM EDT)
10.00 AM - 10.15 AM - Questions and answers from Day 1
10.15 AM - 11.00 AM - Validation and Use of Excel in the QC Laboratory
Designing spreadsheets for compliance
Validation approach for spreadsheets – single and multiple-use spreadsheets
When, what and how much to test?
GAMP 5 recommendations
How to ensure spreadsheet data integrity
11:00 AM - 11:15 AM - Break
11.15 AM – 12.15 PM - Configuration management and change control
The IEEE standard for configuration management
The change control process for planned changes
Unplanned changes
Upgrading software
What to test after changes
How to document changes
12.15 PM – 1.00 PM - Periodic revalidation of chromatography data systems
The approach and practice of periodic review
Using periodic review to reduce frequency of revalidation
Criteria for time-based revalidation
Incidents requiring revalidation
Validation tasks after installing security and other patches
1:00 PM - 1:45 PM - Lunch
1.45 PM - 2.30 PM - Handling raw data and other laboratory records
Definition of raw data: electronic vs. paper
Acquisition and recording of raw data
How to make accurate and complete copies of raw data
Changing records
Archiving of raw data and ready retrieval
2.30 PM - 3.00 PM - Ensuring Integrity and Security of GMP data
Most frequent security and integrity issues
The importance of electronic audit trails
Review of electronic audit trails: who, what, when and how
3:00 PM - 3:15 PM - Break
3:15 PM - 4.30 PM - Auditing Laboratory Computer Systems
Using FDA inspection practice
Importance of data governance policy and controls
Preparing inspection-ready documentation
Responding to typical inspectional/audit observations
4.30 PM - 5.00 PM - Wrap up - Final questions and answers