Some of the hot topics
Analytical instruments and computerised systems operating in regulated laboratories must be fit for intended use. This is achieved by using a combination of analytical instrument
qualification (AIQ) and computerised system validation (CSV). In the current regulatory environment instruments and systems must ensure data integrity and therefore technical controls must be enabled to ensure this as well as being included within the scope of a CSV project. Regulations, either current interpretations of existing ones or following the issuance of updated ones, allow for risk-based approaches but many laboratories either do not consider this or are held back by ultra conservative quality assurance departments. This course is intended to take a practical and risk-based approach to integrated AIQ and CSV. Instead of automating the status quo any laboratory process should be mapped and redesigned for electronic working by removing spreadsheets and paper printouts. To achieve this requires the implementation of applications that are technically compliant. To reduce the amount of work in a CSV project we will consider:
• Effective interpretation of applicable regulations and guidance
• How to leverage supplier development and testing into the project
• Understand the key principles ofthe FDAs newComputer SystemsAssurance initiative to CSV.
• Effective use of risk assessment to focus testing
• Impact of IaaS (Infrastructure as a Service) and SaaS (Software as a Service) on CSV projects for larger laboratory informatics applications such as ELNs, CDS and LIMS.
• Effective risk-based change control from operating system patches to application upgrades
Get to know the Trainer
Bob McDowall is an analytical chemist with nearly 50 years of experience, including 15 years working in the pharmaceutical industry, followed by 28 years working for the industry as a consultant. He has 35 years’ experience in computerized systems mainly within involving analytical systems and laboratory informatics. He is the 1997 LIMS Awardee from the LIMS Institute presented for advances and training in the subject. Bob was a co-author of the revision of USP <1058> on Analytical Instrument Qualification that integrated instrument qualification and computerised system validation that was updated in 2017. Bob has also been involved with the validation of computerized systems for over 30 years and is the author of Validation of Chromatography Data Systems, 2nd Edition published in 2017. His latest book is Data Integrity and Data Governance: Practical Implementation for Regulated Laboratories was published in 2019 by the Royal Society of Chemistry. He is a member of the GAMP Data Integrity Special Interest Group, contributing to the Records and Data Integrity Guide in 2017 and two Good Practice Guides on Data Integrity Key Concepts and Data Integrity by Design. Bob is also the author of the “Questions of Quality” and “Focus on Quality” columns in LCGC Europe and Spectroscopy magazines, respectively. He is in continual demand to speak at the most prestigious events on risk management and internal audit.
Feel free to suggest the topics that you would like to learn about at
our Risk-Based Validation of Laboratory Computerised System In-house Training.
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Who should attend?
• Laboratorymanagers, supervisorsandanalytical scientists responsibleforinstruments and systems
• Computer validation personnel
• Quality assurance
• IT staff responsible for regulated computerised system
