2 Day Virtual Analytical Instrument Qualification and System Validation Course: August 16-17, 2022 – Yahoo Finance
DUBLIN, Aug. 2, 2022 /PRNewswire/ — Final days to register for the “Analytical Instrument Qualification and System Validation” training course that has been added to ResearchAndMarkets.com’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
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
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
Key Topics Covered:
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
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
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
Speakers:
Mark Powell
Fellow
Royal Society of Chemistry
Dr Mark Powell is a Fellow of the Royal Society of Chemistry (RSC) with over thirty years’ experience as an analytical chemist. Mark was Honorary Treasurer of the RSC’s Analytical Division and led a working group on continuing professional development until July 2016, when his term of office ended. Between 2003 and 2013, he was the Analytical Development Manager, and later Scientific Manager, of a UK-based contract research organization which specialized in early-stage oral drug development.
During this time, 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 set up 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 has recently co-authored a White Paper on Pharmaceutical Data Integrity for the laboratory supply company VWR.
For more information about this training visit https://www.researchandmarkets.com/r/81q441
Media Contact:
Research and Markets
Laura Wood, Senior Manager
press@researchandmarkets.com
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