https://www.123articleonline.com/rss/author/201273/adam-flemingArticles written by Adam Fleming from 123ArticleOnline.comen-usCopyright (c) 123ArticleOnline.com All rights reserved. https://www.123articleonline.com/articles/1178710/controlled-document-system-for-a-life-sciences-manufacturing-plant-principles-of-lean-documents-an All life science businesses are required to maintain their Quality Management System (QMS) processes in a state of control, via controlled documents and objective evidence in the form of records. https://www.123articleonline.com/articles/1172964/death-by-capa-does-your-capa-program-need-a-capa In this webinar, the speaker will discuss the fundamentals of a CAPA program. You will learn how you can make your CAPA program more efficient and more effective. https://www.123articleonline.com/articles/1178709/drug-master-files-understanding-and-meeting-your-regulatory-and-processing-responsibilities This combined Quality Agreement and DMF (Drug Master Files) training will discuss the advantages for suppliers and drug product manufacturers developing these arrangements together. https://www.123articleonline.com/articles/1175181/eu-medical-device-regulation-mdr-updated-ce-marking-process-iso-134852016-expectations This EU Medical Device Regulation (MDR) 90-minute webinar will discuss the recently developed regulation and its impact on the future compliance and registration of medical devices in the EU. https://www.123articleonline.com/articles/1178707/european-union-device-regulation-eu-mdr The EU MDR replaces the MDD and expands the requirements for conformance. The MDR contains 174 pages with 123 "Articles" in 10 "Chapters" and 17 "Annexes". https://www.123articleonline.com/articles/1175183/process-capability-analysis-by-means-of-confidence-reliability-calculations The webinar begins with a discussion of relevant regulatory requirements, as motivation for calculating "confidence/reliability". Then, some vocabulary and basic concepts are discussed. https://www.123articleonline.com/articles/1170760/quality-is-not-an-organization What does Quality mean to you? Is it a noun meaning an attribute or characteristic measured against a standard or customer requirement? Is it a state of product being free from defects? Is it an organization within your company that is responsible for creating inspection standards or a quality system? Or is it something more? It can be something more powerful for your company. https://www.123articleonline.com/articles/1175186/risk-management-implementing-iso14971-2019 In this webinar, the speaker will explain the basic principles and practices of Risk Management approach and Risk Analysis. You will also get an understanding of some of the common errors you may encounter while dealing with risk management. https://www.123articleonline.com/articles/1171826/sample-size-determination-for-design-validation-activities This webinar discusses many issues present in any sample size determination, Also discusses several common applications that require an appropriate sample size determination including Reliability Demonstration/Estimation, Estimating proportions, Acceptance Sampling for Lot Disposition, and Hypothesis Testing. https://www.123articleonline.com/articles/1172965/save-your-food-business-business-continuity-disaster-recovery By attending this webinar you will Understand the important aspects of business continuity, Also will discuss the different types of Disasters, The course will also outline ways to prevent such impact in the future. https://www.123articleonline.com/articles/1175401/software-as-a-medical-device-samd-new-ivdr-document-requirements This course will ensure that IVD Diagnostic companies will know exactly what documentation needs to be prepared for a 510(k) regulatory filing, specifically for the software portion of the submittal so that it will be in compliance preventing delays of the 510(k).