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199 results of "Life Sciences x" and "Medical Devices x"
Live Webinar

Mobile Medical Apps(is it a FDA regulated device) and Cyber Security

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 j ...

Live Webinar

Data Integrity and Privacy: Compliance with 21 CFR Part 11, SaaS/Cloud, EU GDPR

Details the requirements for Part 11 and Annex 11: SOPs, software product features, infrastructure qualification, and validation This highly interactive training uses life examples and explores proven techniques for reducing costs, usually by two-thirds, as ...

Live Webinar

HACCP - How To Create A HACCP-Concept And How To Deal With CP's And CCP’s?

The HACCP methodology as risk management methodology is mandatory for pharma and food manufacturing and quality assurance. A quality assurance department needs to create and maintain HACCP files documentation and find and define the checkpoints (CP) and critic ...

Live Webinar

Validation Essentials for Medical Device Manufacturers - IQ, OQ, PQ

This course will cover validation essentials for medical device manufacturers. Attendees will learn about what processes needed to be validated and what steps you need to take to validate processes. You’ll learn the essentials of validation planning, protocol ...

Live Webinar

How to Properly Investigate OOS Results

This webinar will review the regulatory requirements for investigating an OOS Investigation. The responsibilities of the analyst, the supervisor and QA will be discussed. A detailed flow chart will be used to help the attendees clearly understand the steps and ...

Live Webinar

Clinical Trial Master File (TMF) and Electronic Trial Master File (eTMF)

Companies engaged in the conduct of human clinical trials must adhere to specific government regulatory requirements.  Certain documents, content and images related to a clinical trial must be stored and maintained, and depending on the regulatory jurisdicti ...

Live Webinar

Human Error Reduction Techniques for Floor Supervisors

Supervision plays a crucial role in Human Error Reduction and Control. Critical Factors like preparation, planning, scheduling, communication, among many others, will be discussed as part of this webinar. People make mistakes because they can; our systems allo ...

Live Webinar

Post Market Surveillance with the new Medical Device Regulation EU MDR 745/2017

This webinar will help you understand the requirements of the new medical device regulation EU MDR 745/2017 and teach you how to create the reports. The understanding of the changes and how to implement last-minute changes until May 2020 is essential to keep y ...

Live Webinar

Device Changes and the 510(k) – Hardware and Software

This webinar will evaluate two recently published U.S. FDA Guidance Documents on device changes: 1) “Deciding When to Submit a 510(k) for a Change to an Existing Device Final Guidance for Industry and FDA Staff”; and 2) “Deciding When to Submit a 510(k) for a ...

Live Webinar

Adverse Event Reporting and Product Recalls

This training program will provide the regulatory requirements for complaint handling in the pharmaceutical & medical device industries. The course will touch on complaint sources and details will be furnished on the interrelationships regarding complaint hand ...