WHO SHOULD ATTEND Government Contractors who have passed a DCAA Pre-Award Audit, under contract award Government Contractors/Professionals who wanting to understand the DCAA requirements Professionals who are new to Government Contracting whose companies are operating under CPFF & T/M contracts Subcontractors operating under a Prime Contractor with Cost Type or T&M contracts AGENDA

The Digital Education Leadership Conversation (DELC) is a unique education event that unites CIOs, CTOs, curriculum technologists, policy makers and senior IT industry executives from around the country. For 15 years, we have been convening education leaders to discuss and explore new ways of thinking about our schools through group interaction. Free of charge to public-sector leaders, the Conversation is a valuable opportunity for innovators...

Petroliferous Basins-2015 is going to be held during December 07-09, 2015 in Philadelphia, USA to share the advancements in the field of Petroleum Exploration and Development. The main theme of the Summit is “Basin Evaluation, Research, Modelling and Development". This Global Summit aimed to expand its coverage in the areas of Upstream sector of Petroleum Engineering where expert talks, young researchers presentations will be placed in e...

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: 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: 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...