Purchase any WEBINAR and get
10% Off
CODE: SAVE10
T&C applicable, please referFAQ
Validity : 15th Apr'24 to 25th Apr'24
System Suitability, Allowable Adjustments and Data Quality
- System Suitability as the start of the Quality Assurance Framework supporting chromatographic data reliability
- Discuss the factors that impact System Suitability and the relation of System Suitability to Instrument Qualification
- Key elements of a Quality Assurance Framework
- Selection of appropriate System Suitability parameters and the relationship of each parameter to support product quality
- Extension of System Suitability across a sequence
- Application & limitations of Allowable Adjustments
- Application of System Suitability in methods with multiple analytes
- Approaches to investigation of System Suitability failures
Overview of the webinar
This webinar provides a concise overview of the role of System Suitability testing to establish and maintain the reliability of chromatographic data quality. Rather than simply being a trivial but necessary barrier to generating chromatographic data, this webinar provides an overview explaining the essential role of a well-designed System Suitability in allowing the assurance of the continuing quality and reliability of the data generated by the chromatographic system. This webinar discusses the applicability of USP Allowable Adjustments in routine analyses, investigations and method development. A discussion of investigating System Suitability failures is included.
Who should attend?
- Director of Analytical Development
- Manager of Analytical Development
- Director of Quality Control
- Manager of Quality Control
- Pharmaceutical Supervisors
- Chemists
Why should you attend?
Anyone seeking a better understanding of the role of System Suitability, Allowable Adjustments and the support of data quality. Anyone benefiting from understanding that System Suitability only provides an assurance that the system is ready to generate data, but does not provide an assurance of data quality without being extended throughout the measurement process. Anyone seeking to design system suitability parameters providing the greatest support for data quality with the least instrument time. Those working to understand the application of System Suitability in methods with multiple analytes. Investigators wanting to learn how to address investigation of System Suitability failures.
Faculty - Mr.Richard Youngstrom
Richard Youngstrom is a Principal Compliance Consultant in the Pharmaceutical industry with extensive experience (30+ years) in GMP Laboratory Compliance, Quality System improvements and analytical method development. In 2013, Richard retired from his position as Director of Quality Control at Braintree Laboratories and transitioned into Pharmaceutical consulting to help pharma clients meet current regulatory guidelines and improve laboratory compliance and efficiencies; i.e. leveraging his expertise in auditing, OOS laboratory & manufacturing.
Mr. Youngstrom started his career with Schering Corporation in early drug discovery and advanced through several positions to Senior Group Leader in Radiochemistry.Following Schering, he worked for a variety of companies, subsequently holding senior positions at TEVA Pharmaceuticals, Hercon Laboratories, Andrx Pharmaceuticals, Nycomed US and Braintree Laboratories.