Regulatory observations are clearly demonstrating the safety concerns about unexpected peaks, or unknown components discovered in related substance analyses, which are typically performed using chromatographic techniques. However, they may also appear in other chromatography based tests not designed or validated to quantify related substances. Ignoring or suppressing detection of abnormal peaks, even if they do not trigger typical ICH Q3 specification limits, can instigate significant health concerns, as we learnt from the unexpected appearance of nitrosamines in drug products. In this webinar we will illustrate the lessons learnt from the nitrosamine incident, and other impurity related observations, to suggest best practices for dealing with abnormal, unusual, unexpected or unknown peaks in chromatographic analyses.
Heather Longden - After a number of years in training, supporting and selling Waters Software, Heather's current role is as a specialist in compliance to e-record regulations, acting as a resource to the global informatics community at Waters and the users of all Waters informatics products.This involves helping design the compliance into our informatics products and services, attending and presenting at specialist conferences, keeping up to date on the latest interpretations and amendments to the regulations and disseminating this information to the Waters field and corporate organizations.As well as for internal education, Heather is also often called on to present on the latest Data Integrity observations to users of UNIFI, NuGenesis and Empower. Along with Waters Professional Services experts, Heather offers advice to users how to design Standard Operating Procedures and configure the applications to take advantage of the technical controls built into the applications. Heather is also active in the ISPE GAMP Community of Practice and the ISPE New England Chapter where she is called on as an expert in Data Integrity, specifically around the chromatographic analysis.