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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 ...
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 ...
Whether in an informal setting or a more formal presentation, we all want to bring our “A Game” any time we speak up in a meeting or express our ideas. Plan to join us if: Quite frankly, you hate public speaking You’ve been embarrassed because you get shak ...
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 ...
Unlock the potential of AI in finance with our transformative webinar, "ChatGPT for CPAs and Finance Professionals". In this 90-minute session, delve into how ChatGPT can be your partner in navigating complex financial landscapes, from automating routine accou ...