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SUMMARY:Aseptic Processing Virtual Training
DESCRIPTION:This one-day virtual training delivers the knowledge and tools needed to implement best-in-class procedures in aseptic processing. The elite faculty covers recent changes to Annex 1\, aseptic principles\, facility design\, development\, implementation and validation\, media fills\, data analysis\, and inspection readiness. \n\nUnderstand What the Recent Changes for Annex 1 Mean for You\nModernize Your Aseptic Processing Procedures\nKnowledge Management – Review Recent 483s and Avoid Non-Compliance\nLearn Effective Design Criteria and Program Maintenance Processes\nDevelop and Implement Environmental Control\, Cleaning\, and Sanitization Programs\nUnderstand Aseptic Principles\, Component Sterilization\, and Single Use Technology\nOvercome Common Problems in Sterilization\nLearn Alternative Methods in Aseptic Processing – Isolator Usage\, Blow Fill and Seal Technology\, Restricted Access Barrier Systems (RABS)\nLearn How to Manage Media Fills – Frequency and Size\, Duration\, Manipulation\, Incubation Methods\, Failure Investigations\, Corrective Actions\, SOPs\nImplement a Risk- and Quality System-based Approach to Aseptic Processes\n\nFaculty:\nJR Humbert – Vice President\, Quality\, INCOG BioPharma Services\nParsa Famili\, MSc – President & CEO\, Novatek International\nSheba Zama – Head Of Product Specialists And Training Services\, Novatek International\nDavid W. Vincent\, MPH\, Ph.D. – Chief Scientific Officer\, VTI Life Sciences \n  \n 
URL:https://ntint.com/event/aseptic-processing-virtual-training/
CATEGORIES:Virtual Training
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ORGANIZER;CN="KENX":MAILTO:info@kenx.org
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DTSTART;TZID=America/New_York:20220126T090000
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SUMMARY:TRAINING: PDA 612.1 Analysis of Environmental Monitoring Data with Respect to cGMP and Data Integrity Guidelines
DESCRIPTION:This training course offers a deep dive into the analysis required for Environmental Monitoring (EM) with specific consideration to cGMP and Data Integrity guidelines. As such\, the training course is two-fold. The first portion focuses on primarily data analysis for EM. This is for both routine data analysis as well as the analysis required for excursions and investigations with respect to process risks and industry requirements/guidelines. The second portion deals with assessing and maintaining compliance to data integrity guidelines. These two seemingly independent subjects are tied together when we consider that data integrity best practices are required for compliant and meaningful data analysis. Data analysis performed for EM must be risk based\, including assessment of data integrity. Furthermore\, data integrity tools – such as accurately tracing actions through audit trails – can be crucial to investigations\, an area cited by regulators. \nTrainer: \nSheba Zaman \nHead of Product Specialists and Training Services at Novatek International \n\n\n\n\nLearning Objectives\n\n\nConduct detailed EM data analysis for both routine\, state of control monitoring\, including frequency\, filtering data\, grouping data and selection of the meaningful analysis types (e.g. tabular\, regression\, control chart etc.)\nConduct detailed EM data analysis as well as non-routine data analysis for excursions and investigation with an understanding of the regulatory expectations\nExplain the inherent risks in EM data management and their counter measures\nDefine an overview of the general data integrity guidelines from all organizations and identify possible causes of a breach. Demonstrate true understanding of Quality Culture with respect to its effects on data integrity\nDemonstrate the ALCOA+ principles including the reason behind each principle and its applicability in routine operations and root cause analysis\n\n\n\n\n\n\n\n\n\n\nWho Should Attend\n\n\nThis training course is intended for professionals who are involved in viable and non-viable environmental monitoring\, particularly for those investigating or performing data analysis\, including supervision of such analysis.
URL:https://ntint.com/event/training-pda-612-1-analysis-of-environmental-monitoring-data-with-respect-to-cgmp-and-data-integrity-guidelines/
CATEGORIES:Virtual Training
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