Past Event

Analytical Instrument Qualification and System Validation (COM)

14–15 September 2017
Boston, MA, United States

Analytical Instrument Qualification and System Validation (COM)

Thu, Sep 14, 2017, 8:30 AM –
Fri, Sep 15, 2017, 4:30 PM EDT

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

Who Will Benefit:

    IT/IS managers and system administrators
    QA managers and personnel
    Laboratory managers and supervisors
    Validation specialists
    Software developers
    Regulatory affairs
    Training departments
    Documentation departments

Companies and departments

    Pharmaceutical development and Quality control laboratories
    Quality control laboratories of API manufacturers
    Contract laboratories

Day 01(8:30 AM - 5:00 PM)

    8:30 – 9:00 AM: Registration
    9:00 AM: Session Start Time
    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 02(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


Dr. Ludwig Huber
Director and Chief Editor, LabCompliance

Dr. Ludwig Huber is Director and Chief Editor of, the global on-line resource for validation and compliance issues for laboratories . Mr. Huber is an expert for FDA and equivalent international compliance and for ISO/IEC 17025 laboratory accreditation. He is also the Chairman, presenter and panel discussion member at US-FDA industry training sessions and conferences.

He served as a team member of PDA's task forces "21 CFR Part 11", of US-FDA internal documents, and of the GAMP� special interest group on laboratory equipment. In addition, he was awarded as Presenter of the Year of the Institute for Validation and Technology. He is the author of the books “Validation and Qualification in Analytical Laboratories, and "Validation of Computerized Analytical and Networked Systems", Interpharm Press.

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  • Dr. Ludwig Huber Director and Chief Editor, LabComplianceFind out more

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