Training Doyens

OVERVIEW Part 1 QMS is the catch phrase for accreditation and is the backbone of ISO/IEC Standard 17025: The Quality System Manual (QSM) is the bible in a QMS environment because, much like its predecessor, Good Laboratory Practice (GLP), it contains the policies that the laboratory is expected to follow to achieve quality results. It is in fact only the “what to do” component of a QMS. What is also needed are the “how to do it” or procedures and methods and finally the controls or evidence that it was done properly. This is the 1st of two webinars on this topic and focuses on complying with themanagement requirements of the standard. Part 2 Many laboratories regard Quality Assurance, Quality Assessment and Quality Control as independent activities, others use the terms interchangeably, e.g. QA/QC. This demonstrates a lack of appreciation of the differences between Assurance, Assessment and Control, as well as the interrelationships, particularly between QA and QC. This has...

OVERVIEW Instrumental liquid chromatography is ananalysis widely used to determine purity, the impurities, and the degradationproducts of pharmaceuticals . The focus of most validation work is on the methodology, the standard operating procedure (SOP). But validation of the instrumentation and other associated items of column, solvents, and other reagents and chemicals is also an area of focus in an audit. Validation of HPLC/UPLC methodologies WHY SHOULD YOU ATTEND In order to meet US EPA or FDA requirements, a method must meet many stringent requirements. The more important of these for specific analytical methods are method validation and instrument validation. Not do so, is a non-compliance in which any data is not usable or reportable. AREAS COVERED Instrument validation The pumping system The column The detection system The Data System Monitoring for Quality WHO WILL BENEFIT Chemists and laboratory assistants who perform HPLC or UPLC analyses under G...