The Agile approach is well established in other industries adoption of Agile in medical device development has been increasing in the past five years. Experience is showing that both quality and safety are improved when the development team is agile, and that regulatory requirements can still be met. This session will delve into several key areas for applying Agile in the medical device context, including: Countering the village rumors Underst...

When contemplating the use of a supplier you would normally have many requirements and expectations that must be met. These include technical, regulatory, quality, responsiveness, location, readiness, and those less defined but critical. One of the tools at your disposal to verify the supplier's acceptability is to audit its operation. This webinar is designed to provide the participants a working knowledge of supplier audits. The why, when, w...

Written specifically for businesses, not-for-profits and government agencies, this 90-minute information packed course delves into the best practices every organization should implement to detect and mitigate the threat of ACH fraud. From internal controls and processes, to services you should discuss with your financial institution, this course helps any size organization reduce their exposure and risk. Regardless of how relentless the fraud...

This webinar training will discuss how to create, test and implement an effective cyber Incident program to counter cyber threat and malware attacks. The Instructor will explain how to measure an organisation's susceptibility to a cyber attack and will outline critical action areas in such event. Why should you Attend: Do you have great procedures in place to deal with a Breach, Malware and more? Are you willing to risk your Business Reputatio...

During this introductory session, delegates will gain a complete guide to the status and impact of the latest guidelines for combination products. Examples (company specific) of combination products will also be discussed to gain insights into their variety and complexities. Regulatory Requirements EU/US The webinar will clarify the regulatory requirements of combination products and address life-cycle management Examining the regulatory requi...

With $49 billion worth of imported foods, the FDA and its regulatory allies oversee more than 420,000 domestic and foreign facilities. Importers of food products intended for introduction and consumption in the United States through international commerce are responsible for ensuring that the products are safe, sanitary, wholesome, and labeled according to U.S. requirements. Over 70% of all seafood and 35% of all produce consumed in the U.S. a...

Learn from Excel expert David H. Ringstrom, CPA, how to create resilient and practical budget spreadsheets in this informative webcast. David shares a wide range of helpful techniques, including how to separate inputs from calculations, streamline formula writing, preserve key formulas, and create both operating and cash flow budgets. In addition, he explains the uses and benefits of a variety of Excel functions, including CHOOSE IFNA, IFERROR...

Process validation is an important element in medical device manufacturing. This presentation looks at the underlying statistical concepts to perform an effective process validation. The presentation examines elements of the FDA regulations for process validation (21 CFR §820.75) as well as the corresponding requirements in ISO 13485:2016. When you cannot (or do not) fully verified process results by subsequent inspection and test this le...

VBA is the programming language that is built in to Excel (and the other applications in the MS Office Suite).VBA is used to automate tasks that would otherwise have to be performed manually by pressing keys and selecting items with the mouse-and if that sounds like a macro-well it is. Why should you Attend: VBA is one of the must have skills for Excel Power Users. VBA will save you, your colleagues and your customers hours of time by allowing...

This course will show how psychological factors enter into the engineering profession. Many aspects of the engineering profession are nontechnical such as balancing "green" practices with an effective cost structure, engineering ethics, how detail oriented should an engineer be, employee mental fitness for work, manager's leadership style, and communication between engineers. Why should you Attend: A project will suffer if there is not an unde...