Presented by: David W. Vincent, MPH, Ph.D., CEO and Chief Scientific Officer, VTI Life Sciences This Webinar recording will cover the following:Regulatory Requirements: Contamination Control Strategy & Cross Contamination• The view of EU GMP Annex 1• The view of US-FDA: Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice• ASTM – Clean […]
Presented by: Pedro Ferreira, Head of Validation and Quality and Risk Management Services, ValGenesis®ICH Q9(R1) introduced the need to manage and minimize subjectivity in risk management in order to enhance scientific sound risk based decision making. In this presentation, a practical approach to respond to this need is outlined in the context of a production […]
Presented by: Michael Lund, Program Manager, Hyde Analytical LaboratoriesAnalytical testing, coupled with a robust sampling method with high recovery, is essential to confirm equipment surfaces have been properly cleaned during cleaning validation or verification. The selection of an appropriate cleaning analytical method is integral to the accuracy of test results generated during cleaning validation or […]
Presented by: Hector Felix, Senior Validation Engineer at VTI Life SciencesThis webinar will cover the best practices you must implement whether you ship or store temperature-sensitive products. Participants will learn about the regulator context, what has to be done, and how with real concrete examples and case studies.The course details will include:DefinitionTemperature Mapping IntroductionWhy should […]
Presented by:Frank Meledandri Sr., Associate Director, Quality Strategy Quality Management, BDRoy Devine, GPO Computer System Validation, BDModerator:Jason Spiegler, SVP of Strategy, Sales, and Marketing, Compliance GroupBD’s Roy Devine and Frank Meledandri Sr will share their experiences in driving a risk-based CSA methodology. In addition to touching on procedural and cultural change, they will share aspects […]
