Overview: The webinar covers factors considered by FDA before, during and after an inspection that can be used to predict your inspectional vulnerability. Once you know some key points, you will see that FDA's approach to inspections follows well-established procedures and risk criteria that enables FDA to characterize your firm's compliance. Usually the only way FDA will let you know about your profile is when an official action is indicated....

Overview: Business Administration is often very generalized and even more often overlooked by project managers. This course is targeted to teach you the strategic and business administration concepts that are specific to project management. Too many times we try to manage our projects in a vacuum without awareness of how we impact the company overall, and how the company overall impacts our performance as project managers. Why should you Atten...

Overview: Biosimilars in the US, including new regulations, existing guidelines, direction from Congress, meetings with the FDA, INDs that have been filed and NDAs that have been filed. We will also discuss the current state of affairs in Canada, who seems to be closely aligning itself with Europe. Finally, we will address Europe and where the landscape is in terms of approval and market accessibility. We will address an interchangeability stu...

Overview: FDA continues to enforce Part 11 through its new Part 11 inspection and enforcement program. Just in the last 3 years, FDA issued more than 30 warning letters with Part 11 violations. Citations are related to inadequate integrity, security and availability of electronic records but also related to validation of software and computer systems. There are many questions about the program, e.g., what inspectors are looking at what are maj...

Overview: Attacker's attack 24x7 and Computer Security Incident Response for a company, government agency or organization must also be ready 24X7. Both reporting incidents and disseminating incident-related information correctly is a must. Many businesses have not provided adequate training and testing consideration to security issues .Testing and Testing helps raise awareness among and help respond to potential organized computer attacks. Gat...

Overview: In this presentation you will learn the importance of root cause analysis and how it fits into an effective corrective and preventive action system. There will be a review of the principles of Corrective and Preventive Action. Risk Management is a current FDA hot topic, and Root cause analysis and Risk Management are intimately connected, and using risk management principles while doing root cause analysis is not only smart but cost...

Overview: 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...

Overview: This webinar discusses the concepts of cyber safety and cyber security associated with SHE-related risk identification and mitigation in order to evaluate associated risks and mitigations. Cyber safety and cyber security axioms appropriate to risk identification and mitigation are discussed. Why should you Attend: Principle managers concerned with SHE risk related to automation and computers: SHE analysts SHE professionals SHE creden...

Overview: The Food and Drug Administration Modernization Act (FDAMA) requires that manufacturers track certain devices when the agency orders them to do so. Tracking is intended to facilitate notification and recall in the event a device presents a serious risk to health that requires prompt attention. The tracking provisions enacted by SMDA required mandatory tracking even if FDA did not issue an order. Specifically, section 519(e), as added...

Overview: Defined Failure Investigation and Root Cause Analysis is a major tool in product complaint, non-conformance, and OOS failure investigations, and hazard analysis / risk management and mitigation activities, the basic foundation of a viable CAPA system. It is required in resolving verification and validation issues including data outliers that frequently but are often improperly dismissed arbitrarily. It is required in order to "close-...