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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. Artificial ...
Human error is a leading cause of quality and production issues, but many of these errors can be minimized with effective workplace organization and management. The 5S Method—Sort, Set in Order, Shine, Standardize, and Sustain—is a proven approach to creating ...
Computer system validation has been regulated by FDA for more than 30 years, as it relates to systems used in the manufacturing, testing, and distribution of a product in the pharmaceutical, biotechnology, medical device or other FDA-regulated industries. The ...
FDA requires that all computer systems used to produce, manage and report on “GxP” (GMP, GLC, GCP) related products be validated and maintained in accordance with specific rules. This webinar will help you understand the FDA’s current thinking on vendor audit ...
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.You will learn about the types of FDA inspections, preparations such as assigning personnel to specific tasks for the inspection, f ...
This highly interactive Webinar offers you and your team an array of practical tools to help you get things done in today's chaotic and constantly changing work environment. You’ll learn practical techniques for making structured decisions—even under pressure— ...
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. From p ...
This webinar will explain the process of analyzing and minimizing cyber risks for premarket submissions. It will explain how cyber risks are identified and mitigated. Concepts from the 2025 Guidance will be explained. The cybersecurity program must be carefull ...
In a world where information is constant, and attention is fleeting, storytelling has emerged as one of the most powerful tools in a leader’s and human resource professional’s toolkit. Why? Because facts alone don’t inspire people. Data doesn’t spark transform ...
This webinar will discuss the US FDA’s Final Guidance on the Q-Submission Program, dated May 29, 2025, which addresses how to request interactions with the FDA related to future medical device submissions. This allows companies and the FDA to arrive at mutual ...