This webinar will examine the existing requiements for theUS FDA's DHF - including its derivitive documents, the DMR and DHR, and the identical ISO 13485 7.3 D&DF.
This webinar will provide valuable guidance to regulated companies in development and implementation of formal, defined, documented methods for analysis of product changes and when to file a new 510(k).
The FDA holds companies responsible for filing new 510(k)s when one change is major enough to impact safety/effectiveness, or when a series of lesser changes finally reach the "tipping point".
FDA QMSR requires that medical device companies carefully select suppliers and contract manufacturers.
The US FDA has announced steps toward a new regulatory policy and framework specifically tailored to promote the development of safe and effective drugs using advanced artificial intelligence / machine learning algorithms by the regulated industry.
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.
This webinar will provide valuable guidance to regulated companies in development and implementation of Project Management Planning and Techniques with ChatGPT / AI assistance for new product development, regulatory compliance audit responses, proof of "progress against plan", and other activities requiring a planned documented rationale.
In this webinar you will learn how to prepare for an inspection and how to respond to a 483 or Warning letter if you receive one.
The artificial intelligence technologies granted FDA marketing authorization and cleared by the agency so far are generally called “locked” algorithms that don’t continually adapt or learn every time the algorithm is used.
This course will teach how to conduct a software validation program for medical devices containing software that will satisfy FDA requirements and produce a safe product.
Verification and validation requirements have always been part of the US FDA's GMPs.
Join us for an engaging and informative webinar, " ChatGPT Made Simple: Everyday Uses for Work, Life & Productivity," where we unravel the power of ChatGPT, an advanced AI language model, and explore its practical applications in everyday life.
Workplace Respect Redefined: Building Stronger Teams Through Inclusive Communication training is typically designed to educate employees on the importance of fostering a culture of respect, inclusivity, and professionalism in the workplace.
This 90-minute webinar provides essential guidance on recognizing, preventing, and responding to workplace violence.
The "Resume Writing Basics with ChatGPT" webinar is designed to help job seekers at all levels craft resumes that stand out in today's competitive market.
Join us for this timely and informative webinar designed to help employers, HR professionals, and compliance officers navigate the latest updates to Form I-9 and federal verification requirements.
Introduction to E-Verify is a practical, beginner-friendly webinar designed for employers, HR professionals, nonprofit administrators, and small business owners who want a clear understanding of how employment eligibility verification works in the United States.
Winter Safety in the Workplace training in the workplace is a vital program designed to educate employees on the potential hazards associated with exposure to cold conditions and equip them with the necessary knowledge and skills to protect themselves and their colleagues.
In today's fast-paced world, staying ahead means leveraging the latest technology to simplify and enhance everyday tasks. The "ChatGPT for the Common Person" webinar offers a unique opportunity to understand and utilize one of the most powerful AI tools available-ChatGPT.
This 90-minute webinar provides essential guidance on recognizing, preventing, and responding to workplace violence. Participants will learn how to identify early warning signs, understand risk factors, and implement practical strategies to keep employees safe.
