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Validity : 30th Nov'23 to 10th Dec'23
This webinar will define what are the US FDA's expectations for the use of statistical techniques, e.g., 21 CFr 820.25, for establishing, controlling, and verifying the acceptability of process capability and product characteristics, sampling plan justificatio ...
The training session aims to provide participants with an understanding of the International Council for Harmonization (ICH) Q9 guideline, with a focus on the revised version, ICH Q9(R1). Participants will learn about the principles, concepts, and application ...
There are new roles that require a thorough understanding of functional interrelationships if you are to succeed. With the knowledge and practical methodology learned in this course, you will have the ability to boost your supplier’s performance.
This training on FDA software validation and verification will provide you with the best practices necessary to ensure that all systems are validated in compliance with FDA regulations.
Purchasing Basics 101 begins with definitions of the terms used in procurement and then provides a starting place of drafting a procedure manual, establishing bidding limits, and creating a procurement workflow. Next attendees will learn how to start a procure ...
This webinar will focus on cybersecurity of medical devices, a key concern for those who develop, manufacture, test, and distribute these products. Protecting medical devices from hacking where someone can alter the actual code embedded in the device could res ...
We will delve into the five essential design principles inspired by the renowned expert, David JP Phillips. In an era where effective communication is paramount, these principles offer invaluable guidance to transform your presentations from mundane to mesmeri ...
How do you know how well your suppliers are doing? Most responses present a subjective view. It is akin to throwing darts - sometimes you are close, but most times you are "off-target". You need a tool that will provide an objective, quantitative visibility ...
linical trials are research studies in which people volunteer to help find answers to specific health questions. When carefully conducted, they are the safest and fastest way to find new treatments and ways to improve health. Clinical trials are conducted acc ...
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 in ...