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Validity : 23rd Jun'26 to 03rd Jul'26
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 ...
This webinar will provide valuable guidance to regulated companies in development and implementation of Project Management Planning concepts including some common chatbot / AI tools (and their risks), Lean / Agile principles, for new product development, Desig ...
Auditing is a critical function in any organization, ensuring compliance, accuracy, and efficiency in various operations. While traditional auditor certification training provides a solid foundation in auditing principles, procedures, and standards, it often f ...
An OSHA inspection provides a view into your organization’s safety culture. This training will share a step-by-step guide on how to strategically prepare for a safety audit before it happens, which includes newly defined rules that employers need to know. Addi ...
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 ...
This webinar will provide valuable guidance to regulated companies in development and implementation of Project Management Planning concepts including some common chatbot / AI tools (and their risks), Lean / Agile principles, for new product development, Desig ...
Auditing is a critical function in any organization, ensuring compliance, accuracy, and efficiency in various operations. While traditional auditor certification training provides a solid foundation in auditing principles, procedures, and standards, it often f ...
Verification and validation requirements have always been part of the US FDA’s cGMPs. However, with increasing technology, both industry, and regulatory agencies' expectations have increased. Recent high-profile field problems indicate that V&V activities are ...
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 ...
Instrumental gas chromatography is an analysis are widely used to determine purity, the impurities, and the degradation products of pharmaceuticals. The focus of most validation work is on the methodology, the standard operating procedure (SOP). But validation ...