Waters

-Overview of international guidances for data integrity -Insight into PIC/S guidances -Challenges of managing documentation

• What constitutes data integrity? • Selecting the right applications and training for GxP environments • Audit preparedness

• Disaster recovery and business continuity plans are crucial for companies. • Most laboratories are not confident in their recovery and continuity plans. • When seeking solutions for system failures, consider regulatory guidelines.

• How to achieve efficient and high-throughput separations of proteins • Optimizing column technology can enhance RPLC

Traditionally mass detection instruments have been for the mass spec experts and not played a major role in the majority of chromatography labs. With the advent of smaller, more accessible mass detectors, the potential of mass data is coming more and more within the reach of the chromatographer. With this webcast we look to see how the landscape of the chromatography lab is changing and how the value of mass data can be realized by the chromatographer.

Uncertainty in chromatographic method development and quantitative experiments often arises. RADAR can detect uncertainty, discover co-eluting compounds, collect full scan MS data and monitor the background matrix, enabling fast method development.

The Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (jointly referred to as PIC/S) provide good manufacturing practice (GMP) guidance for the lifecycle of a product. The scope of this executive summary is to provide a brief high-level overview of GMP, the impact of PIC/S, and compliance with the PIC/S document PE 009-12 “Guide to Good Manufacturing Practice for Medicinal Products Annexes“ Annex 11 Computerized Systems.