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NetZealous LLCMobile Applications,IT, FDA Compliance ,DatabaseWhat does this course offer?Attend this webinar to understand the FDA guidance for mobile applications. We will discuss the key areas that are most important during inspection and audit, including security, data integrity, validation, training, and documentation. We will pay special …
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Health & care: FDA Regulation of Dietary Supplements
NetZealous LLCHealth & care,FDA Regulation,Health,EngineeringWhat does this course offer?FDA regulates both finished dietary supplement products and dietary ingredients. FDA regulates dietary supplements under a different set of regulations than those covering "conventional" foods and drug products. Under the Dietary Supplement Health … -
Engineering: FDA Regulation of Artificial Intelligence/ Machine Learning
NetZealous LLCMachine Learning,Engineering, FDA Regulation,Software engineering,DevelopmentWhat does this course offer?AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective. FDA has regulated medical software by means of regulation and guidance's for years, however, AI/ML programs fall outside the scope of these regulations … -
Health & care : FDA's New Import Program for 2020
NetZealous LLCHealth & care,FDA,Accounting and finance, CareWhat does this course offer?The FDA and U.S. Customs and Border Protection are using new import requirements. The FDA's import software screening program (PREDICT) and the U.S. Custom's ACE software program require more information from the foreign source(s). FDA's product codes and U.S. … -
Health and safety: Good Documentation Practices to Support FDA Computer System Validation
NetZealous LLCComputer System Validation,Health and safety,Manufacturing, Food safetyWhat does this course offer?As a "GxP"system, following Good Manufacturing, Laboratory and Clinical Practices, the computer system must be validated in accordance with FDA requirements. If electronic records and/or electronic signatures (ER/ES) are incorporated into the system …
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IT: Project Management for FDA-Regulated Companies
NetZealous LLCProject Management,IT,FDA,BusinessWhat does this course offer?...planned documented rationale. Three of the most common tools will be discussed. Why you should Attend: The FDA expects companies to manage projects formally to include regulatory requirements, design and/or change control, with consideration of all applicable standards. The EU … -
Engineering: FDA's Cloud Compliance & Regulations
NetZealous LLCStrategic Management,Engineering,Project management,Engineering managementWhat does this course offer?This presentation will provide a baseline of information related to cloud computing which will help the attendee better understand the cloud concept, associated regulatory challenges, and suggestions for consideration when establishing a cloud based system. -
Health & care: FDA's New Import Program for 2020 and Impact of the COVID-19
NetZealous LLCHealth & care,FDA,HealthWhat does this course offer?In this interactive session author will discuss the impact of the COVID-19 and the FDA's required information for the PREDICT software screening prior to entry and Custom's Harmonized Tariff Schedule (HTS). The FDA and U.S. Customs and Border Protection …
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Health & care: Complying with FDA's Good Documentation Practices
NetZealous LLCFDA's Good Documentation Practices,Health & care, Psychology, Clinical psychologyWhat does this course offer?...within a company can directly impact the level of success in quality of products that are safe as well as success during audit situations. Consequently, GMP /GLP /GCP regulations from PIC/S, FDA, ICH and EU all include mandatory sections on documentation. Why you should Attend … -
Engineering: Human Factors/ Usability Studies following ISO62366 and the new FDA Guidance
NetZealous LLCHealth & care,Medicine, Biomedical science,medical devices,EngineeringWhat does this course offer?...the effectiveness of the studies will be explained. The various types and methods of human factors analysis will be explained. This process conforms to the new ISO 62366 standard and the new FDA Guidance document. Why you should Attend: The FDA will only approve devices which … -
Marketing: 3-Hour Virtual Seminar on FDA's Scrutiny of Social Media Promotion
NetZealous LLCSocial Media Promotion, FDA,Marketing , Business MarketingWhat does this course offer?FDA steadily expands the scope and restrictions for promotion of products under its jurisdiction. Whatever and where ever to want to talk about your product, just assume your talking to FDA. Trolling for off-label information in social media, scrutiny … -
Health & care: Mobile Medical Apps(is it a FDA Regulated Device) and Cybersecurity
NetZealous LLCMobile Medical Apps,Health & care,Medicine, Medical teachingWhat does this course offer?This webinar will explain how to determine if your app is a medical device and if it will be subject to FDA requirements. The FDA approval process for a new app will be explained including FDA requirements for software validation which are more extensive than … -
Environmental: Technical Documentation Files - The US FDA and EU MDR Requirements
NetZealous LLCEnvironmental, Health & care, Environmental health, CareWhat does this course offer?...; (the old "Essential Requirements"); Structure of the "Declaration of Conformity"; self-declaring changes and/or N-B reviewed; Parallel approaches to development. Finally, the differing approaches to file audits by the FDA and the Notified Body will be discussed … -
Health & care: Computer System Validation (CSV) for FDA-Regulated Computers
NetZealous LLCComputer System Validation,Business, Health & care,Psychology, Clinical psychologyWhat does this course offer?The Webinar will focus on the importance of ensuring that the validation of an FDA-regulated computer system will meet compliance guidelines. This includes development of a company philosophy and approach, and incorporating it into an overall computer system … -
Engineering: Usability Validation Test following ISO 62366 and the 2016 FDA Guidance
NetZealous LLCHuman Factors,Engineering,Construction ,Environmental engineeringWhat does this course offer?This webinar will explain the procedure described in ISO62366 and the 2016 FDA Guidance for a compliant human factors/usability validation. HF/U validation is very different from device validation. For example, success criteria is qualitative rather than … -
The 6 Most Common Problems in FDA Software Validation and Verification
NetZealous LLCWebinar on FDA Software Validation and VerificationWhat does this course offer?...equipment, exposing the validation process to scrutiny. Corporate uncertainty leads to inaction and "wheel spinning." Many companies struggle with understanding how to avoid major mistakes when validating software to FDA standards. Why you should Attend: Avoid … -
3-Hour Virtual Seminar on What do the FDA, EMA and PMDA Look
NetZealous LLCWhen Conducting cGMP Regulatory InspectionsWhat does this course offer?It has often been stated that "FDA inspects for compliance; European inspectors inspect for adequate science". Yet GMPs have been enshrined into law for many countries and a drug/biologic/medical device manufacturer should have a reasonable expectation … -
Health & care: 21 CFR Part 11 - Compliance for Electronic Records and Signatures
NetZealous LLCElectronic Records and Signatures,21 CFR Part 11,Health & care,Data scienceWhat does this course offer?This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA regulated companies and how conformance to Part 11 differs from just having good IT security. Procedures for controlling electronic signatures and electronic records as described … -
Food science: Verification vs Validation-Product, Process or Equipment and QMS Software
NetZealous LLCFDA, GAMP, 21 CFR Part 11,Manufacturing, Food science, DieteticsWhat does this course offer?The verification and validation of regulated software is coming under increased scruinty by the U.S. FDA. This webinar will address the use of the FDA, GAMP, 21 CFR Part 11,"Electronic Records"/"Electronic Signatures", IEC 62304, and other … -
Environmental- Electronic Records & Electronic Signatures; 21 CFR Part 11; Basic Concepts
NetZealous LLCHealth & care , Health,Environmental ,health EnvironmentalWhat does this course offer?Documented Part 11 training, as with any FDA regulation, is required for staff members who have responsibilities within the scope of the regulation. Understanding the requirements of Part 11 is critical to compliance with the regulation. Knowledge of regulatory … -
Marketing: Responsibility for Off-label Claims in Social Media
NetZealous LLCSocial Media,MarketingWhat does this course offer?FDA's sweeping definition of labeling includes what is said or represented, even by images, in a social media platform. If the information can reach a consumer, FDA cares, even if you did not publish the information. Firm's need to watch for promotional … -
Health & care: Medical Device Risk Management following ISO 14971:2019
NetZealous LLCMedical Device Risk Management,Health and safety,Health & care , Medicine,Medical teachingWhat does this course offer?The US FDA expects that as part of a product development Design Control Program risk management will be conducted. FDA also expects that a post production risk management program be implemented. FDA recommends using ISO 14971 as a guide and has accepted it as a … -
Management: Handling OOS Test Results and Completing Robust Investigations
NetZealous LLCAirport management ,Travel & tourism, Airport,Aviation ManagementWhat does this course offer?...investigations are amongst the most frequently found deviations in FDA warning letters. Most companies have procedures but either they are not adequate or are not followed. This webinar will guide attendees through the entire process from detection an out-of-specification result … -
Health & care- Drug Master Files: Understanding your Regulatory Responsibilities
NetZealous LLCQuality Agreement training,Manufacturing,Health & care, HealthWhat does this course offer?...and enforcement climate within FDA and the manner, in which Drug Master Files (DMFs) are reviewed by FDA personnel. Besides the US, the use of DMFs in the EU, Japan, Canada and Australia will also be discussed. Similarities and differences to the U.S. system will be highlighted … -
IT: How to Conduct a Human Factors/ Usability Validation
NetZealous LLCHuman Factors,Engineering, IT,Development,Software engineeringWhat does this course offer?This webinar will explain the procedure described in ISO62366 and the 2016 FDA Guidance for a compliant human factors/ usability validation. HF/U validation is very different from device validation. For example, success criteria is qualitative rather than …