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: Analytical equipment should be qualified and computer systems should be validated to demonstrate suitability for the intended use. Electronic records must comply with FDA Part 11 and EU/PICS GMP Annex 11 requirements to ensure data integrity, security and availability. Recent EU and FDA inspection documents prove that qualification, validation and electronic laboratory are records are on target of inspectors. The large number of warn...

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...

Course "Equipment, Facility, and Process Qualification and Validation - A Simple Top to Bottom Sustainable Approach" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Companies face many common issues and confusion when creating or revamping their validation programs. Some of these common issues are: Company has expertise in its process validation program...

Overview: Educational material discussed during this seminar will include both effective sanitation and hygienic practices and the control of microorganisms that cause spoilage and foodborne illness. After a discussion of microorganisms found in meat products, safety issues will be addressed and contamination sources identified. Practices to reduce contamination such as personal hygiene and Good Manufacturing Practices (GMPs) will be discussed...

The Human Capital Management for Government Training Series brings together key stakeholders from throughout the Federal and Defense HR Community to discuss best practices for managing human capital, improving efficiency & advancing innovation. Launched in 2006, the series of events has evolved into the meeting place for strategic-level policy makers and operational-level HR managers, and often serves as the catalyst for new initiatives. T...

The SiMT will host “Thinking in 3D,” Additive Manufacturing Symposium 2015. We’re excited that our keynote speaker for the event is Dr. Brian Post of the Oak Ridge National Laboratory. Dr. Post's research at ORNL’s Manufacturing Demonstration Facility includes the development of large scale additive manufacturing processes capable of producing large parts (8’ x 20’x 6’, 1000+lb) at rates 1000x faster...

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-...

Overview: Make sure our current thinking on defining, establishing, and documenting the responsibilities of each party (or all parties) involved in the contract manufacturing of drugs subject to Current Good Manufacturing Practice (CGMP) as well as vendors supplying product specific raw materials unique to this product. In particular, we will discuss how parties involved in purchasing critical raw materials that can generate patient risk and w...

This webinar will address the complexity of defining safe food. We will look at the changing nature of foodborne/food transmitted pathogens, new and emerging analytical technologies and the influence of demographics and geography on the changing landscape. The webinar will also discuss roles and responsibilities for mitigating food contamination and foodborne illness from farm-to-fork. Why should you Attend: Combined with an ever growing at-r...