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Online Conference Biomedical : 3-Hour Virtual Seminar on DHF, DMR, DHR, TF , Design Dossiers - The Requirements
Overview: This webinar will examine the existing and proposed requiements for the U.S. FDA's DHF, 21 CFR 820.30 and now ISO 13485:2016 7.3 including its derivitive documents, the DMR and...
Online Conference Biomedical : Effective Design of Experiments (DOE) Strategies
Overview: This DOE (Design of experiments) training focuses on DOE strategies. It is not focused on statistical methods, analysis of variance, and other techniques, but rather the overall ap...
Online Conference Biomedical : Protocol Deviation Reporting and Management
Overview: Protocols are living documents that are often routinely amended throughout the life of a clinical trial. Due the ever-fluid nature of a protocol's evolution, as well as the pot...
Conference / Seminar Law and Health : Clinical Evaluation Report for Europe and MEDDEV Expectations: Impact with New Medical Device Regulations (MDR) Seminar
Course "Clinical Evaluation Report for Europe and MEDDEV Expectations: Impact with New Medical Device Regulations (MDR)" has been pre-approved by RAPS as eligible for up to 12 credits toward...
Concerned sectors: Law and Health -
Online Conference Public Health : Historical Perspective of the Part 11 Regulation
Overview: This presentation will provide an overview and historical perspective of the Part 11 regulation, the general Part 11 requirements,electronic records requirements, and electronic signatures ...
Concerned sectors: Public Health -
Conference / Seminar Acupuncture : European Medical Device Regulation / key changes overview
Course "European Medical Device Regulation / key changes overview" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full co...
Concerned sectors: Acupuncture -Biomedical -
Online Conference Biomedical : Best Practices to Support FDA Computer System Validation
Overview: We will cover the importance of maintaining the documentation from every computer system validation effort in a "current" state. The system must be maintained in a validated state...
Concerned sectors: Biomedical -Public Health -
Online Conference Public Health : Spreadsheets for 21 CFR 11 Compliance 2018
Overview: Spreadsheet Applications such as MS Excel are frequently used in 21 CFR 11 compliant environments, but they were not specifically designed for regulated environments and their development i...
Concerned sectors: Biomedical -Public Health -
Online Conference Biomedical : When to Submit a 510(k) for a Change to an Existing Device
Overview: This presentation, will aid manufacturers of medical devices who intend to modify a 510(k)-cleared device or a preamendments device subject to 510(k) Why should you Attend: This present...
Concerned sectors: Biomedical -Public Health -
Online Conference Acupuncture : Cloud Software Applications for 21 CFR Part 11
Overview: This webinar demystifies Part 11, and get you on the right track for using electronic records and signatures to greatly increase productivity. Areas Covered in the Session: Which data a...
Concerned sectors: Acupuncture -General Medicine -
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