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Computerised Systems in Analytical Laboratories
20 November 2018
It is the aim of this Conference to discuss the different applications of LIMS, ELN, LES, SDMS, PLM, ERP, etc. and to show how LIMS can be implemented in today’s QC and R&D environment. Technical issues will also be addressed, e.g. how to integrate “old” systems into current Lab IT.
This year the current data integrity challenges in analytical labs will especially be addressed: which are the actual regulatory expectations (WHO, MHRA and FDA) and what are the expectations of a GMP inspector.
Practical Data Integrity and Audit Trail Reviews will be other focus areas of this course. A paperless laboratory case study will show how close analytical labs can get there today.
The paperless laboratory has been a dream in QC and R&D for a number of years. It offers the possibility to improve and accelerate the analytical processes in the laboratory on one hand, and to save money and costs on the other hand.
But the integrity and security of laboratory data, records, results, and information is fundamental for running a successful GMP regulated QC laboratory. This applies for the classic analytical lab as well as for microbiology or other labs both, for in-house labs or contract labs.
To develop a secure, stable and “validable” laboratory information management system (LIMS) - maybe even compatible with an already existing system - is a real challenge for LIMS suppliers. And the successful implementation and validation of a LIMS in compliance with GAMP and GMP requirements (EU Annex 11, US 21 CFR Part 11, PIC/S, etc.) is a huge challenge for all pharmaceutical QC and R&D departments.
Topics that will be addressed are:
- Regulatory Requirements.
- Integration of “old” Systems into current Lab IT
- Case Study: Paperless Laboratory
- Data Integrity for “Dummies” OR Practical Data Integrity
- Audit Trail Review
- Ensuring Data Integrity throughout the Supply Chain
- Integrating Devices and Systems in QC (and Production) to enable Data Driven Decisions
This conference is aimed at the following attendees:
- Laboratory personnel working in GMP laboratories in the pharmaceutical industry, contract research organisations, contract manufacturing organisations and API manufacturers
- Employees involved in the implementation and use of LIMS
- Quality Assurance /Quality Control (Quality Manager, Quality Systems Project Leader, Laboratory Head, QA Director)
- Lab Information Management
- ELN and LIMS Project Leader
- IT, Informatics and Support
- LIMS Suppliers
Alternative Microbiological Methods: AstraZeneca's, GSK's, Johnson&Johnson's, MSD's and Roche's Global Implementation Roadmap
Miriam Guest, Astra Zeneca / Philip Breugelmann, JnJ / Dr Sven M. Deutschmann, Roche
- Introduction & Overview
- Alternative Microbial Enumeration Method(s)
- Alternative Sterility Test(s)
- Alternative ID-Test(s)
Dr Frank Sielaff, GMP Inspector Regional Authority Darmstadt
- Overview of the regulatory framework
- Computerised systems in the context of lab data integrity
- What are the expectations of inspectors?
The Real Problem - Integration of Existing Instruments to Lab Systems
Andreas Steinle, Roche
- Integration layer – A key for efficient data management
- Data availability for data scientists and for all systems (no point to point)
- Faster decisions and changes with an agile approach for legacy systems
- High scalability from a small satellite laboratory to a global company
- High flexibility at lower costs for business
- Independency from the (big) vendors
- Integration of existing lab standards (e.g. AniML) and upcoming standards (e.g. SiLA 2, Allotrope)
- Easier integration of future challenges (e.g. IoT, machine learning and cloud)
Case Study: Paperless Laboratory
Florian Göhner, Vetter Pharma Fertigung
- Introduction: a Paperless Laboratory Project in the context of Industry 4.0
- How to set-up, initiate and control a Paperless Lab Project in QC environment
- The sentiment barometer: An introduction on how to keep the good mood by project marketing
- Integration of lab instruments in existing and to-be IT environments and data-sharing between IT systems
- The process of the future: analyze, harmonize and standardize QC Lab Processes
Data Integrity for “Dummies” OR Practical Data Integrity
Rob Hahnraths, Bayer
- How to document SMART User Requirements Specifications
- Practical „Fit for Intended Purpose“ by example
- How to develop and understand Risk Assessments
- Empower Migration Do and Dont‘s
Audit Trail Review
Tejs Kyhl, ALK-Abelló
- Electronic audit trails are one of the key components in achieving compliance with regulatory expectations for data integrity. But are you using them?
- Understand the regulatory requirements for audit trail review
- Know when to perform audit trail reviews in the QC laboratory
- Learn the added benefits of knowing your audit trail
- Simplify audit trail reviews by searching your audit trail and know what to look for
Ensuring Data Integrity throughout the Supply Chain
Dr Danilo Neri, PQE
- Regulatory authorities became focused more and more on Data Integrity and regulated companies are required to strictly ensure Data Integrity throughout the data lifecycle
- Overarching Data Governance to be established through a Corporate Data Integrity Program and to be addressed and monitored at each site
- Implementation of guidance documentation to ensure the compliance for each GxP records either created by the company or acquired by a supplier (e.g. CMO, Contract Testing Laboratory, CRO).
- Regular risk reviews of supply chains and outsourced activity to evaluate the extent of data integrity controls required
- Enhanced Supplier Qualification process to ensure the reliability of the GxP Data provided to the regulated company
- Verification strategy to assess the current practices for regulated electronic and paper records
- Monitoring of the level of Data Integrity compliance through supplier oversight and follow up
Integrating Devices and Systems in QC (and Production) to enable Data Driven Decisions
Sinead Cowman, Lonza
- How to connect devices and systems to derive value from the data they generate and error proof your workflows and processes based on Client examples
- Technical and business process considerations for interfaces
- Understanding raw data and determining what data belongs in what system
- Data Integrity compliance
- Review by exception
Dr Markus Dathe
F. Hoffmann-La Roche, Switzerland
Sinead Cowman, Lonza Slough
EU Business Development Manager – Informatics.
Florian Göhner, Vetter Pharma Fertigung, Germany
Rob Hahnraths, Bayer, Germany
IT Consultant - QA & Validation Services at Bayer. Co-lead of the GAMP® DACH Audit Trail review working group.
Tejs Kyhl, ALK-Abelló, Denmark
Senior Chemist, Laboratory Automation Development. Heads a team of specialist within data integrity and computerized systems validation in the QC laboratories.
Dr Danilo Neri, PQE, Italy
Validation Project Manager with expertise on Computer System Validation.
Dr Frank Sielaff, Regional Authority Darmstadt, Germany
GMP-Inspector with focus on Inspection of drug manufacturers and laboratories in Germany and countries outside of the EU.
Andreas Steinle, Roche Diagnostics, Germany
Manager Digital Solutions in Pharma Technical Development Europe.