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Analytical Instrument Qualification and System Validation  

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Seminar Summary:

This will provide attendees the regulatory background and guidance through the complete process from planning and writing requirement specifications to vendor assessment, installation and operational qualification and ongoing testing during routine use. (see full course description)


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Training Course Syllabus:

Analytical Instrument Qualification and System Validation: 2- day In-person Seminar

Course Description:

Analytical equipment should be qualified and computer systems should be validated to demonstrate suitability for the intended use. Electronic records must comply with FDA Part 11 and EU/PICS GMP Annex 11 requirements to ensure data integrity, security and availability. Recent EU and FDA inspection documents prove that qualification, validation and electronic laboratory are records are on target of inspectors. The large number of warning letters issued to laboratories also demonstrate that they struggle with either understanding or implementing the regulations.

This 2-day course provides the regulatory background and guides attendees through the complete equipment qualification, calibration and computer system validation processes from planning to reporting. It also helps to fully understand Part 11 and Annex 11 requirements to ensure and document integrity and other requirements for electronic records and signatures.

The course not only ensures a full understanding of the regulations and guidelines for equipment and records but also provides templates and examples to develop inspection ready documentation. Interactive exercises will be dispersed into and between the presentations. About 50% of the total time will be dedicated to practical sessions. Here attendees work in small groups on case studies and prepare the answers using prepared fill-in templates. After the course a large variety of tools such as SOPs, validation examples and checklists will be readily available on a dedicated website that can be used to easily implement what they have learned in the course.

Learning Objectives:

Attendees will:
Learn about the regulatory background and requirements for equipment qualification according to USP <1058> and computer system validation according to GAMP Guides
Be able to explain the difference between equipment calibration, qualification and system validation
Learn which equipment/systems need to be qualified or validated
Be able to allocate equipment and systems to USP <1058> and GAMP categories and to design and execute qualification/validation protocols accordingly
Understand the logic and principles of instrument qualification and system validation from planning to reporting
Be able to explain your company’s qualification and validation strategies
Understand how to archive raw data from hybrid systems: electronic vs. paper
Be able to define and demonstrate Part 11 compliance functionality to auditors and inspectors
Be able to develop inspection ready documentation during on-going routine operation
Learn how to ensure, document and audit integrity of raw data and other records

Course Outline:

Day One (8:30 AM - 5:00 PM)

08.30 AM - 09.00 AM: Registration

09.00 AM: Session Start

09.00 - 09.45: Requirements and approaches for Analytical Instrument Qualification

FDA/EU, PIC/S requirements
Qualification/calibration issues in FDA inspections
USP Chapter <1058>: current and proposed changes
The instrument qualification lifecycle
Planning for cost-effective calibration/qualification

09.45 - 10.30 (*): Going through the qualification phases

Writing requirement specifications
Installation and installation qualification
Testing for initial operational qualification
Leveraging system suitability testing for on-going performance qualification
Preparing inspection ready documentation

10:30 - 11:00: Break

11.00 - 11.45 (*): Testing and deviation handling

Developing generic test protocols
Documenting test evidence
Going through an example test protocol
Review and approval of test results
Handling deviations

11.45 - 12.30: Retrospective qualification and Requalification

Qualification of existing systems
Leveraging past experience
Time based requalification
Event based requalification
What and how much to test

12:30 - 13:30: Lunch

13.30 - 14.15 (*): 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

14.15 -15.00 (*): 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

15:00 - 15:30: Break

15.30 - 16.15 (*): Requirements and approaches for Laboratory Computer Systems

FDA Part 211, Part 11, PIC/S Annex 11
Most critical inspection findings
Which systems need to be validated
Learning from the new GAMP® guide: “A Risk based Approach to Laboratory Computerized Systems”
Examples for risk assessment of computer systems

16.15 - 17.00 (*): Validation of Laboratory Computer systems

Writing a validation project plan
Going through a complete laboratory computer system validation from beginning to end
Integrating the GAMP® guide with USP <1058> for integrated instrument and system validation
Writing a validation report as a mirror to the plan
Preparing inspection ready validation documentation

Day Two (8:30 AM - 4:30 PM)

08.30 - 09.00: Review of day

Questions and answers from Day 1
Main conclusions and action items

09.00 - 10.00 (*): Validation and Use of Excel in the QC Laboratory

Designing spreadsheets for compliance
Validation approach for spreadsheet applications
When, what and how much to test?
Recommendations from GAMP®5 for testing native Excel functions
How to ensure spreadsheet and data integrity

10:00 - 10:30: Break

10.30 - 11.15 (*): Configuration management and Change control

The IEEE model for configuration management and change control
The change control process for planned and unplanned changes
Versioning of software and computer systems
What to test after changes
How to document changes

11.15 - 12.00 (*): Periodic review and revalidation of chromatographic data system

The approach and practice of periodic review
Using periodic review to reduce frequency of revalidation
Criteria for time based revalidation
Incident requiring revalidation
Validation tasks after installing security and other patches

12:00 - 13:00: Lunch

13.00 - 13.45 (*): 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 of data and other records
Archiving of raw data and ready retrieval

13.45 - 14.30: Ensuring Integrity and Security of Laboratory (Raw) data

Most frequent security and integrity issues: going through recent 483's, EIRs and warning letters
The importance of electronic audit trail to document data integrity
Review of electronic audit trail: who, what, when and how
Examples how to ensure and document data integrity

14:30 - 15:00: Break

15:00 - 16.15 (*): Auditing Laboratory Computer Systems and records for FDA Compliance

Using FDA Inspections as model for laboratory audits
Going through a typical FDA computer system inspection
Preparing inspection ready documentation
Responding to typical inspectional/audit deviations
Learn how to avoid or respond to FDA 483s and warning letters

16.15 - 16.30: Wrap up – Final questions and answers

Seminar Summary:

This will provide attendees the regulatory background and guidance through the complete process from planning and writing requirement specifications to vendor assessment, installation and operational qualification and ongoing testing during routine use. (see full course description)

print this agenda print agenda for the Analytical Instrument Qualification and System Validation training seminar

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