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FDA Submissions – Page 5 – globalcompliancepaneltraining
Category Archives: FDA Submissions
The importance of meeting Supplier Management criteria
Meeting the supplier management criteria set out by the FDA, the ISO and the QSR regulations is mandatory for the regulated industries. The qualification and assessment of suppliers is binding for the regulated industries. Being in compliance with the requirements for supplier management set out by the FDA and by the ISO and QSR standards […]
Posted byGlobalCompliancePanel-Training September 11, 2017 September 11, 2017 Posted inA Tour of the FDA, fda, FDA 21 CFR Part 11 Compliance, fda audit, FDA Compliance, FDA organized, FDA regulatory 510(k), FDA Submissions, history of the FDA, New FDA FSMA Rules, UncategorizedTags: da inspection guidelines, design, education, fda, FDA 21 CFR Part 11, FDA approval, fda audit, fda regulation, fda supplier audit requirements, inventory management, iso internal audit checklist, Medical, medical device contract manufacturing, supplier management, supplier management system, supplier quality managementLeave a comment on The importance of meeting Supplier Management criteria
Navigating the nuances of the Internet of Medical Things
Earlier this year, Gartner released a forecast for the Internet of Things (IoT)predicting that 8.4 billion connected things will be in use worldwide in 2017 and that total spending on endpoints and services will reach almost $2 trillion this year. This forecast is certainly encouraging, but due to the prevalence and influence of the Internet of […]
Posted byGlobalCompliancePanel-Training September 6, 2017 September 6, 2017 Posted inA Tour of the FDA, fda, FDA 21 CFR Part 11 Compliance, fda audit, FDA Compliance, FDA organized, FDA regulatory 510(k), FDA Submissions, history of the FDA, MEDICAL DEVICE, medical device reporting and recalls, medical devices, Medical Devices Training, Medical Professionals, New FDA FSMA Rules, UncategorizedTags: compliances, education, fda, FDA 21 CFR Part 11, FDA approval, fda regulation, HEALTHCARE, Medical, medicine, Project Management, regulatory requirements in educationLeave a comment on Navigating the nuances of the Internet of Medical Things
Software project management has an important tool in the Agile methodology. The Agile methodology developed as a product of the gradual efforts at arriving at a team based methodology of iterative software development. Because of its close association with software, in terms of suitability; Agile is to software development what Lean is to manufacturing. Among […]
Posted byGlobalCompliancePanel-Training August 7, 2017 Posted inDocumenting, fda audit, FDA Compliance, FDA organized, FDA regulatory 510(k), FDA Submissions, history of the FDA, New FDA FSMA Rules, Software Validation Process, UncategorizedTags: document management software, FDA Guidance, fda medical device software guidance, fda regulations medical devices, fda software development, fda software validation, fda software validation checklist, fda software validation guidance, Manufacturing, qualityLeave a comment on It is important and necessary to document Software for FDA Submissions
Posted byGlobalCompliancePanel-Training July 31, 2017 July 31, 2017 Posted inA Tour of the FDA, Effective legal writing skills, fda, FDA 21 CFR Part 11 Compliance, fda audit, FDA Compliance, FDA organized, FDA regulatory 510(k), FDA Submissions, history of the FDA, New FDA FSMA Rules, Uncategorized, Writing and implementing effective SOP’sTags: e-learning, pharmaceutical regulatory affairs, regulatory affairs certification, regulatory affairs in pharma, regulatory compliance, Regulatory Compliance Training, regulatory submission process, regulatory training, types of regulatory submissionsLeave a comment on Effective legal writing skills are essential for FDA submissions
An effective audit constitutes the heart of an effective Quality System. The FDA and other regulatory agencies have emphasized this principle time and again. The purpose of an audit program is to ensure proper and thorough compliance with the guidelines set out by the regulatory agencies. A Quality Assurance audit should also ensure that the […]
Posted byGlobalCompliancePanel-Training July 26, 2017 Posted infda, FDA 21 CFR Part 11 Compliance, fda audit, FDA Compliance, FDA organized, FDA regulatory 510(k), FDA Submissions, history of the FDA, New FDA FSMA Rules, Quality by Design, Quality Management, Quality Risk Management, UncategorizedTags: fda regulatory compliance, pharmaceutical regulatory affairs training, Quality Assurance, quality risk management in the fda-regulated industry, regulatory affairs courses, regulatory affairs medical devices, what is fda regulated industryLeave a comment on Quality Assurance Auditing for FDA-regulated industries