LIMS System Validation and Compliance Issues For Regulated Labs
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Speaker : DR PHIL WILLIAMS
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When : Wednesday, July 31, 2024
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Time : 01 : 00 PM EST
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Phil Williams has a BA Hons. Degree and PhD in Chemistry, plus he also has UK Qualified Teacher status. He is an independent LIMS consultant with over 38 years of experience in LIMS, Lab automation and materials characterization. He has worked with ICI, AstraZeneca, HEL and Mettler Toledo. He is semi-retired, but specializes in LIMS marketing mainly through his 30,000 LinkedIn connections. He started up LIMS4U in 2009 and is currently helping both a UK and an USA company.
The webinar covers the validation of the Laboratory Information Management System (LIMS) which can be essential for regulatory compliance.
The webinar will cover over a dozen key steps in achieving compliance. The process includes defining operational requirements in a User Requirements Specification (URS), assessing supplier quality systems, and developing Functional Specifications (FS).
Risk assessment guides validation efforts outlined in a Validation Plan (VP), tracking progress through a project plan. Installation Qualification (IQ) ensures proper LIMS installation, followed by system configuration and Operation Qualification (OQ) to confirm functionality. Performance Qualification (PQ) tests real-world performance, often concurrently with OQ for configured solutions.
Traceability matrices ensure regulatory compliance, supported by risk-based change control procedures. User training and updated procedures are integral, along with IT agreements for data backup and disaster recovery.
The Final Validation (FV) report summarizes activities, notes exceptions, and obtains customer sign-off, ensuring the LIMS is ready for use.
Areas Covered
- Why LIMS needs validation?
- Regulatory requirements
- Steps needed to comply
- The cost of getting it wrong
Who Should Attend
- Laboratory Manager/Director
- Laboratory Analyst
- Research Analyst
- Biostatistician
- Chemist
- Bioinformatician
- Medical Laboratory Scientist
- Quality Control Analyst
Why Should You Attend
- Strict controls and procedures in LIMS are required throughout development and operation due to global regulatory mandates. Examples include 21 CFR Part 11, CLIA, EU GDPR, FSMA, GCP, GLP, HACCP, HIPAA, ISBER Best Practices, ISO 15189, ISO 20387 & ISO/IEC 17025.
- Ensuring adherence to industry standards and best practices.
- How to manage internal and external documents with revision tracking?
- Including automation and streaming quality assurance plus quality control processes with traceability.
- Helping to enforces adherence to Standard Operating Procedures (SOPs) to reduce procedural errors.
- How LIMS can help with the tracking of samples, training records, and calibration procedures, management reports etc?
- The consequences of errors in any industry can be severe. In pharmaceuticals, where the repercussions are particularly grave due to their impact on human health, mistakes can lead to significant consequences.
Topic Background
In regulated industries, validating Laboratory Information Management Systems (LIMS) is vital to show compliance with GxP regulations.
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$199.00
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