GlobalCompliancePanel courses

...(90 Mins): CE Marking, 510 K and PMAs general Overview US and EU Life Cycle Management Interfaces: Change Management CTA applications Annual reporting Lecture... Learn about: Change Management, Health Management, Safety Management...

...standards for data security, data transfer, audit trails, electronic records and signatures, software validation, and computer system validation... Learn about: Quality Training, IT risk...

...plan and implement a team approach to preventive controls • Be able to help your food importers to jump through FDA hoops • Develop a system to risk rank... Learn about: Quality Training, Team Training, Food safety...

...If you answered "yes" to any of these questions, then come laugh, listen and learn as Chris DeVany leads us all through those important topics... Learn about: Leadership training, Team Training, Team Work...

...• Validation Coordinators • Production and Process Development Personnel • Regulatory/Compliance Managers • Chemists • Technicians Study Directors(GLP)... Learn about: Risk Assessment, IT risk, Validation specialists...

...(90 Mins): Crisis Management What is Crisis Management? Crisis Management Preparedness Lecture 4 (90 Mins): Change Management and User Adoption Change... Learn about: Change Management, Crisis Management...

...and use process capability • Production Managers and Supervisors • Quality Managers and Supervisors • Quality Engineers • Manufacturing Engineering Managers... Learn about: Quality Training, Process Control, Medical training...

...Pharmaceutical employees often do not realize that by putting their processes in writing, they are making commitments to regulatory agencies... Learn about: Agreement on focus, Knowledge check...

...Speaker: Elaine Eisenbeisz Owner and Principal Statistician, Omega Statistics Elaine Eisenbeisz, is a private practice statistician and owner of Omega Statistics... Learn about: Online Fda manufacturing, Compliance Trainings, FDA trainings...

...to estimate variance associated with: repeatability, intermediate precision, and reproducibility Ensure your process is in (statistical) control and capable... Learn about: Data analysis, Process Control, Medical training...

...significance level, effect size Formulas, software, and other resources for computing a sample size Lecture 3 (90 Mins): Developing a Statistical Analysis... Learn about: Non-regulated training, IT risk, Non-destructive testing...

...Safety Requirements Hazard Mitigation Traceability Verification Planning Architectures, Redundancy, And Diversity Failure Rates / Modes / Types Failure... Learn about: Risk Management, Regulatory Professionals, Product Development...

...Complaint Triage and Handling Complaint Investigations "Closing" Complaints Contents of Complaint Form Complaint Review and Trending Implementation... Learn about: Omplaints and recalls, Complaint and Recall Management, Risk management system...

...Attendees will leave the course clearly understanding of all the requirements for a comprehensive HIPAA compliance program and what steps need to be taken to mitigate... Learn about: Health Management, Compliance Management, HIPAA regulations...

...Computer System Validation (CSV) Lecture 2 (90 Mins): System Development Life Cycle (SDLC) Methodology Lecture 3 (90 Mins): GAMP 5 and Software Categorization Lecture... Learn about: FDA perspective, Computer Security...

...in reporting Medical Writers who need to interpret statistical reports Day 1 Schedule Lecture 1 (90 Mins): Why Statistics? Do we really need statistical tests?... Learn about: Pharma / Medical Device, Clinical Research, Medical Science...

...Mitigation Strategies Software Item, Unit and System Definition Software Failures as Hazard Sources Software Requirements and Design Specification Software... Learn about: IT risk, Medical training, Product Development...

...Directors / Senior Directors of Development Directors / Senior Directors of Commercialization Document Managers Training Managers Regulators Vendors Suppliers... Learn about: IT risk, Medical Science, FDA perspective...

...· Effectiveness Checks · Control, Monitoring, Dissemination of Information · Connections within your Quality Management System o Non-conforming Product... Learn about: Quality Training, Online Excel trainings, Medical training...

...across departments and functional areas Drive continuous improvement by tying corrective actions with complaints for a closed loop quality process Improve... Learn about: IT risk, Quality Training, Medical training...