European Seminar Programme
cGMP Industry Processes and New Productivity Initiatives
- Learn key critical-path data management pressure points in late stage drug development and manufacturing areas
- Understand how paper-based processes cause productivity and compliance challenges in cGMP environments
- Gain insights into compliance and productivity requirements for optimized QC lab operations
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Method Conversion to an all Electronic Systems Approach
- Learn how to present existing analytical test methods and SOP's in digital formats for complete documentation automation
- Learn the key differences between "research" electronic notebooks and GMP electronic notebooks
- Learn how to integrate all lab instruments directly into the digital test method
- Understand current 21 CFR Part 11 Issues and the "paperless lab" - data and metadata requirements
- Gain insights into the interoperability of data in the QC environment - ELNs, LIMS, ERP, CDS system integration issues and answers
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CASE STUDY: Example Metrics in the Pharmaceutical Industry
- See example industry deployments of a method-centric GMP ELN and its impact on automating compliance
- Gain an understanding of deployment time frames, productivity gains and IT architectures for cGMP operations
- Learn how "cGMP Informatics" can impact product release cycle times and manpower requirements
- NEW Agenda Topic - Learn how VelQuest's SmartLab system is integrated with Autoscribe, Ltd. LIMS Stability System for compliant protocal design, lab execution and data management in stability testing operations.
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