Upon completing this course participants will leave with a preliminary preventive control implementation plan and will: Understand US FDA final rules for the Preventive Controls for Human and Animal Foods Define and review your current system to identify gaps in your preventive controls planning. Be able to develop and implement a valid preventive control company food safety plan to close any gaps Write and implement appropriate procedures. Kn...

Since the Food Safety Modernization Act of 2010 was signed into law by President Obama on January 4, 2011, Food Defense is now clearly called out and must be adhered to. These requirements mandate FDA's action in the area of Food Defense, and penalties continue to go higher and higher. With the associated costs related to oversights and recalls, Food Defense is an important economic aspect of any organization. This session is designed for food...

Overview: Recent reports identified several potential benefits to widespread use of UDI, such as reducing medical errors, facilitating recalls, improving medical device reporting, and identifying incompatibility with devices or potential allergic reactions.Why should you attend: Understand how the use of a unique device identification (UDI) system may improve patient safety, e.g., by reducing medical errors, facilitating device recalls, and im...

Overview: Statistical power is an indicator of the ability of a test of significance to "detect" a practical difference (e.g., between the averages of two products that are being compared). A low power typically means that the sample sizes in the study are too small. Without an analysis of statistical power, a conclusion of "non-significant" is rightfully questionable. Unless power is high, a study may be doomed to failure even before it is be...

Overview: The topic is 510(k) changes, a topic that is still producing more than its share of 483's and warning letters. In general, FDA does not return filings because the change described in them is not sufficiently "significant", and only rarely suggests that the traditional 510(k) should at least be scaled down to a special 510(k).Therefore, it is up to the sponsor/manufacturer to determine whether this change will be significant or not. T...

Course "Effective Audit Report Writing: Improve the Quality of your Audit Reports through Advanced Techniques" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: After completing this program, participants will be able to: Understand the report writing provisions in the Standards of the Institute of Internal Auditors. Write audit reports that meet the needs...

Overview: In depth review of advanced payroll issues from how to properly pay employees to review of international payroll policies. Why should you attend? Trying to make sure your company is compliant is very challenging but if your company expands internationally knowing how to handle the payroll can be overwhelming. This seminar will give participants the skills to handle any type of advanced payroll issue that they may face with comfort an...

Overview: It is an unfortunate fact that most water systems today have been designed and are operated and controlled using at least some traditional concepts and methods that are downright wrong. So how could such traditions become so ingrained and be so wrong? How could well-intentioned benchmarking be so misguided?Who Will Benefit: Validation Managers and Personnel Engineers involved in water system design and installation Utility operators...

The ability to develop, support, and manage how costs and prices are derived is essential for everyone involved in U.S. federal acquisition—both buyers and sellers—and is a skill in high demand. Cost and price analysis affects everything from requirements development to the price that is ultimately agreed upon, and the fundamental importance of this critical competency cannot be ignored.

Prerequisite: Should have at least six months of contract experience, have taken the FAR Workshop or another basic FAR course before this course. What you will learn: The Advanced FAR Workshop provides an in-depth analysis of the most important parts of the FAR. In this two-day class, we will focus on those FAR Parts that tend to generate the most issues and questions, specifically: • The classification of workers • Intellectual Prop...