Day One * 7:30-8:00 Continental Breakfast (Provided) 8:00-8:30 Introduction Curtis Wehr/Tiffany Jones 8:30 - Noon QuickBooks Seminar Chart of Account Design (Direct, Indirect, and Unallowable Segregation) Data Entry (Segregation of direct and indirect costs) Set-up Customer Job Center Set-up Employee Center Timecard Compliance and Entry Labor Allocation Payroll Reconciliations Job Cost Report Design and Set-up Contract Segregation—Contr...

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...

Course "Surviving an FDA Inspection: Understand the Do's and Don'ts and the Ground Rules" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Many regulated companies preparing for FDA inspections are not prepared and the outcome can be negative as we see all the time with enforcement actions. This seminar provides the fundamentals and the ground rules on ho...

Course "Mastering Biofilm Control, Monitoring, Validation and Excursion Investigations of Pharmaceutical Water Systems" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: This course is designed to provide a microbiology-focused education about all aspects of water systems and how biofilm manages to thrive there. Prior microbiological education or training,...

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...