Two Day Course: Analytical Instrument Qualification and System Validation (Burlingame CA, United States – February 6-7, 2020) –

DUBLIN--(BUSINESS WIRE)--The "Analytical Instrument Qualification and System Validation" conference has been added to's offering.

This 2-day course guides attendees through equipment qualification, calibration and computer system validation processes 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 regulatory bodies.

Analytical equipment should be qualified, and computer systems should be validated to demonstrate suitability for their intended use. To be acceptable to regulatory authorities, electronic records must comply with 21 CFR Part 11, Annex 11 to EU GMPs and more recent data integrity guidance.

Recent EU and FDA reports demonstrate that qualification, validation and electronic records are priority areas for inspection. The large number of FDA warning letters and the frequency of EU enforcement action in these areas demonstrate that companies sometimes struggle to understand or implement the regulations.

The course not only ensures a full understanding of the regulations and guidelines for equipment and records but helps attendees to develop a risk-based approach to compliance. Interactive exercises will be dispersed into and between the presentations.

Learning Objectives:

  • Learn about the regulatory background and requirements for equipment qualification according to USP <1058> and computer system validation according to GAMP 5
  • 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 5 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 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 personnel
  • Laboratory managers and supervisors
  • Analysts
  • Validation specialists
  • Software developers
  • Regulatory affairs
  • Training departments
  • Documentation departments
  • Consultants



08.30 AM - 09.00 AM - Registration

09.00 AM - Session Start

09.00 AM - 09.45 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

09.45 AM - 10.30 AM - Qualification in Practice
User requirement specifications
Installation qualification
Operational qualification
Preparing inspection-ready documentation

10:30 AM - 11:00 AM - Break

11.00 AM - 11.45 AM - Testing and deviation handling
Developing test protocols
Documenting test evidence
Review and approval of test results
Handling deviations

11.45 AM - 12.30 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

12:30 PM - 13:30 PM - Lunch

13.30 PM - 14.15 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

14.15 PM - 15.00 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

15:00 PM - 15:30 PM - Break

15.30 PM - 16.15 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

16.15 PM - 17.00 PM - 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


08.30 AM - 09.00 AM - Questions and answers from Day 1

09.00 AM - 10.00 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

10:00 AM - 10:30 AM - Break

10.30 AM - 11.15 AM - 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

11.15 AM - 12.00 Noon - 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

12:00 Noon - 13:00 PM - Lunch

13.00 PM - 13.45 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

13.45 PM - 14.30 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

14:30 PM - 15:00 PM - Break

15:00 PM - 16.15 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

16.15 PM - 16.30 PM - Wrap up - Final questions and answers

For more information about this conference visit

Laura Wood, Senior Press Manager
For E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900