Description :The company must establish a program where they identify, analyze and control cybersecurity risks for both pre market and post market. The cybersecurity program must be carefully planned. A formal special hazard analysis must be conducted for each risk. Communication of risks must be sent to device users. A complex set of reporting requirements has been established. This webinar will describe a program that will be compliant to the FDA requirements.Areas Covered in the Session :Cybersecurity planRisk based analysisHazard analysis following ISO14971Risk communication to usersRequired membership in information sharing groupsReporting requirements and the exceptionsWho Will Benefit:company managementIT personnelDevelopment EngineersProduction ManagementQA/ QC personnelSoftware developersAbout Speaker:Edwin Waldbusser retired from industry after 20 years in management of development of medical device products and development of company Quality Systems. Products included IVD…See More

Description :Some of us feel that we have to hire a guru in order to apply the Theory of Constraints.Here are some practical things all of us can do to "chip away" at a constraint - and yield major improvements to your operation.Areas Covered in the Session :Identifying a constraint in a process by its symptoms.How to "chip away" at the constraint. Some steps at the constraint can be done by upstream or downstream operations.How to increase the overall throughput of your production line.Who Will Benefit:Managers, Supervisors, Directors, and Vice-Presidents in the areas of:About Speaker:José Mora is a Principal Consultant and Project Manager specializing in Manufacturing Engineering, Quality Systems, and Lean Transformations. José is a recognized subject matter expert in process validation, lean manufacturing, lean controlled document systems, startup operations, process development and quality systems, having lectured internationally and presented webinars on these subjects.For over…See More