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Colloquium Medical Informatics : Medical Device Software: An Incremental Approach to Risk and Quality Management
Course "Medical Device Software: An Incremental Approach to Risk and Quality Management" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recert...
Concerned sectors: Medical Informatics -
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 -
Conference / Seminar Acupuncture : FDA Software Monsters Cybersecurity, Interoperability, Mobile Apps and Home Use
Race "FDA's Software Monsters: Cybersecurity, Interoperability, Mobile Apps and Home Use" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC r...
Concerned sectors: Acupuncture -Law and Health -
Conference / Seminar Acupuncture : Prepare Your Company to Comply with the New FDA FSMA Rules on the Sanitary Transportation of Human and Animal Foods Seminar
Course "Prepare Your Company to Comply with the New FDA FSMA Rules on the Sanitary Transportation of Human and Animal Foods" has been pre-approved by RAPS as eligible for up to 12 credits to...
Concerned sectors: Acupuncture -Law and Health -
Conference / Seminar Acupuncture : A Risk Based Approach to Excel Compliance with the FDA's 21 CFR 11 and the European Annex 11
Course "A Risk Based Approach to Excel Compliance with the FDA's 21 CFR 11 and the European Annex 11" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant...
Online Conference Biotechnology : When Conducting cGMP Regulatory Inspections 2018
Overview: This webinar will cover the key areas of how ICH Q7 was established, it's goals and objectives, expectations of the healthcare authorities involved and practical differences that you wi...
Concerned sectors: Biotechnology -Public Health -
Conference / Seminar Medical Informatics : Data Integrity: Learn to Comply with the FDA Expectations and Avoid Facing Penalties ranging from Public Warning Letters to Criminal Charges and Product Removal from the Market Place
Course "Data Integrity: Learn to Comply with the FDA Expectations and Avoid Facing Penalties ranging from Public Warning Letters to Criminal Charges and Product Removal from the Market Place"...
Concerned sectors: Medical Informatics -
Online Conference Biotechnology : Revolutionary Change in FDA Software Regulation
Overview: It is not about giving an OK to products, it is about trusting the manufacturer to do the right thing. Overall, your regulatory approach to software regulation needs to ease up and reap the...
Concerned sectors: Biotechnology -
Online Conference Biotechnology : FDA During New (Drug) Development 2018
Overview:  Why is it important to engage with the FDA? To discuss your development plan to support NDA or BLA regulatory submission To identify and mitigate potential issues early To identi...
Concerned sectors: Biotechnology -
Online Conference Biotechnology : Best Practices for Foundational (Employee) Success 2018
Overview: FDA expectations provide some of the framework regarding types and frequency of training, there are decisions that the company will need to make in light of its evaluation of how to best ac...
Concerned sectors: Biotechnology -
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