Analytical Instrument Systems Qualification and Validation Course (October 27-28, 2022) – | Nation/World


“Analytical Instrument Qualification and System Validation” training has been added to the offering.

This 2-day course guides participants through the processes of equipment qualification, calibration and computer system validation, from planning to reporting. It also explains regulatory requirements in these areas, including EU and US GMPs, as well as data integrity guidance documents from national and international regulators.

The course not only ensures a comprehensive understanding of equipment and recording regulations and guidelines, but helps participants develop a risk-based approach to compliance. Interactive exercises will be scattered within and between the presentations.

Learning objectives:

  • Learn more about the regulatory context and the requirements for the qualification of equipment according to USP and validation of computer systems according to GAMP 5
  • Be able to explain the difference between equipment calibration, qualification and system validation
  • Find out which equipment/systems need to be qualified or validated
  • Be able to allocate equipment and systems to USP categories and GAMP 5 and 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 develop a qualification and validation strategy
  • Understand how to archive raw data from hybrid systems: electronic vs paper
  • Be able to define and demonstrate regulatory compliance to auditors and inspectors
  • Be able to develop inspection-ready documentation
  • Learn how to ensure, document and audit the integrity of GMP records

Who should attend:

  • IT/IS managers and system administrators
  • QA managers and staff
  • Laboratory managers and supervisors
  • Analysts
  • Validation specialists
  • Software developers
  • Regulatory Affairs
  • Training departments
  • Documentary services
  • Advisors

Main topics covered:

Day 01 (10:00 a.m. – 5:00 p.m. EDT)

10:00 a.m. – 10:45 a.m. – Requirements and approaches for the qualification of analytical instruments

  • FDA/EU, PIC/S requirements
  • Qualification/calibration issues in FDA inspections
  • USP General Chapter : Qualification of analytical instruments
  • The Instrument Qualification Lifecycle
  • Prioritization of calibration/qualification activities

10:45 a.m. – 11:30 a.m. – Qualification in practice

  • Specification of user requirements
  • Installation qualification
  • Operational qualification
  • Preparation of documentation ready for inspection

11:30 a.m. – 11:45 a.m. – Break

11:45 a.m. – 12:45 p.m. – Tests and management of deviations

  • Development of test protocols
  • Document test evidence
  • Review and approval of test results
  • Gaps treatment

12:45 p.m. – 1:15 p.m. – Lunch

1:15 p.m. – 2:30 p.m. – Retrospective Qualification and Requalification

  • Qualification of existing systems
  • Leverage past experience
  • Time-Based Requalification
  • Event requalification
  • What and how much to test – risk-based approach

2:30 p.m. – 3:15 p.m. – Equipment maintenance and change control

  • Preventive maintenance; tasks, documentation
  • Planned and unplanned changes
  • Modification of hardware, firmware, documentation
  • Identical change definition and management.
  • Management of changes made by suppliers

3:15 – 4:00 p.m.: Type and extent of qualification for USP instrument categories

  • The approach and benefits of instrument classes
  • 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 p.m. – 4:15 p.m. – Break

4:15 – 5:00 p.m. – Requirements and approaches for GMP IT systems

  • 21 CFR Part 211, Part 11, PIC/S, EU Annex 11
  • Most critical inspection results
  • Which systems need to be validated
  • GAMP 5: A risk-based approach for computerized laboratory systems
  • Examples of IT systems risk assessment
  • Validation of laboratory computer systems
  • Writing a validation project plan
  • Integration of GAMP 5 with USP for the validation of instruments and computer systems
  • Writing a validation report

Day 02 (10:00 a.m. – 5:00 p.m. EDT)

10:00 a.m. – 10:15 a.m. – Day 1 Questions and Answers

10:15 a.m. – 11:00 a.m. – Validation and use of Excel in the QC lab

  • Designing spreadsheets for compliance
  • Validation approach for spreadsheets – single-use and multi-use spreadsheets
  • When, what and how much to test?
  • GAMP 5 Recommendations

How to Ensure Spreadsheet Data Integrity

11:00 a.m. – 11:15 a.m. – Break

11:15 a.m. – 12:15 p.m. – Configuration management and change control

  • The IEEE standard for configuration management
  • The change control process for planned changes
  • Unplanned changes
  • Update software
  • What to test after the changes
  • How to document changes

12:15 – 1:00 p.m. – Periodic revalidation of chromatographic data systems

  • The approach and practice of periodic review
  • Using Periodic Reviews to Reduce Revalidation Frequency
  • Time-Based Revalidation Criteria
  • Incidents requiring revalidation
  • Validation tasks after installing security and other patches

1:00 p.m. – 1:45 p.m. – Lunch

1:45 p.m. – 2:30 p.m. – Processing of raw data and other laboratory records

  • Definition of raw data: electronic vs. paper
  • Acquisition and recording of raw data
  • How to make exact and complete copies of raw data
  • Editing records
  • Archiving of raw data and immediate recovery

2:30 p.m. – 3:00 p.m. – Ensuring the integrity and security of GMP data

  • Most common security and integrity issues
  • The Importance of Electronic Audit Trails
  • Reviewing electronic audit trails: who, what, when and how

3:00 p.m. – 3:15 p.m. – Break

3:15 p.m. – 4:30 p.m. – Audit of the Laboratory’s IT Systems

  • Using FDA Inspection Practices
  • Importance of Data Governance Policy and Controls
  • Preparation of documentation ready for inspection
  • Respond to typical inspection/audit observations

4:30 – 5:00 p.m. – Recap – Final questions and answers


Mark Powell


Royal Society of Chemistry

Dr. Mark Powell is a Fellow of the Royal Society of Chemistry (RSC) with over thirty years of experience as an analytical chemist. Mark served as Honorary Treasurer of the RSC’s Analytics Division and led a Continuing Professional Development Task Force until July 2016 when his tenure ended. Between 2003 and 2013, he was Analytical Development Manager, then Scientific Manager, of a UK-based contract research organization specializing in early oral drug development. During this period, he was responsible for method validation, verification and transfer activities, as well as the qualification of laboratory instruments and computerized data systems. In 2013 he established Mark Powell Scientific Limited, which provides training and consultancy services to pharmaceutical companies. Mark has since enjoyed working with companies of all sizes around the world on a variety of training and consultancy assignments, and recently co-authored a white paper on pharmaceutical data integrity for laboratory supplies company VWR. .

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Laura Wood, Senior Press Officer

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SOURCE: Research and Markets

Copyright BusinessWire 2022.

PUBLISHED: 09/26/2022 09:49 / DISK: 09/26/2022 09:49

Copyright BusinessWire 2022.

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