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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.
The training on "FDA 483 or Warning Letter - Now What?" is a comprehensive program designed to equip professionals in FDA-regulated industries with the knowledge and skills needed to effectively navigate and respond to regulatory challenges. When faced with an ...
Test method validation is an often-confusing requirement for medical devices. A fundamental issue is the role-reversal between the test method and the product or process it is designed to detect. For example, while a defect-free process is desirable, a test ...
There are 3 types of 510(k) submissions that can be submitted – Traditional, Special, and Abbreviated. The 510(k) process is considerably more rigorous than it once was, because of the following: Several international standards recognized by the FDA have b ...
If you want to finish your daily task list and assignments and leave work on time, sign up for this webinar. You will benefit professionally as you use Microsoft Outlook features to: Customize your interface to suit your preferences Finish projects on time ...
In this webinar attendees will learn about FDA’s regulatory expectations for classifying, assessing the risk, testing, and validating a computer system used in FDA-regulated work. Also attendees will learn in detail about the System Development Life Cycle (SDL ...
AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective. FDA has regulated medical device software by means of regulation and guidance for years, however, AI/ML programs fall outside the scope of these regulation ...
In the tightly regulated landscape of FDA-controlled industries, successful navigation through inspections is a cornerstone of organizational success. The Most Common FDA Observations and Prevention Strategies' training addresses the critical need for professi ...
Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented. Human errors start at the design stage. Proced ...
This interactive webinar explains how to configure and validate GxP-compliant spreadsheet applications to avoid FDA 483s. Follow the step-by-step instructions as we configure Excel for audit trails, security features, and data entry verification. Understand ho ...