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...

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: QMS is the catch phrase for accreditation and is the backbone of ISO/IEC Standard 17025:2005. The Quality System Manual (QSM) is the bible in a QMS environment because, much like its predecessor, Good Laboratory Practice (GLP), it contains the policies that the laboratory is expected to follow to achieve quality results. It is in fact only the "what to do" component of a QMS. What is also needed are the "how to do it" or procedures a...

Overview: Software's level of complexity and use is expanding at exponential levels. Likewise the potential risks to health follow suit. Problems with software create a number of different hurdles. Software may be a standalone device, control a device's performance, make calculations, identify treatment options or begin to play a more active role in making clinical decisions regarding patient management and treatment. FDA's risk classification...

Course "The A to Z's of HIPAA Compliance" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: This two day seminar takes the participants through HIPAA compliance from start to compliance. The presentations explain the history of HIPAA, why it came to being and its evolution. This covers what HIPAA is, what steps have to be performed to be HIPAA compliant an...

Course "Applying U.S. FDA Laws and Regulations to Each Phase of Total Product Life Cycle (TPLC)" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: This workshop style training course is supported by comprehensive knowledge of U.S. FDA laws and regulations and 30 year of extensive experience working within in the U.S. FDA regulated industries. In these 2 da...

Overview: This course is designed to help scientists and engineers apply statistical methods used assist decision making in process and product development. Variability must be considered when utilizing data to arrive at conclusions. This course will cover Basic Statistics and Graphical Methods used to summarize data. You will learn how to apply Hypothesis Testing methods to determine whether groups are statistically equivalent or not with res...

This 2 day course will cover practical guidance on cleaning validation regulatory compliance, in conjunction with, risk-based, reasonable and informed decision making and activity planning. This two day interactive course will cover fundamental principles of a cleaning validation program, exploring such concepts as the determination of residues to be targeted, selection of analytical and sampling methods, determination of appropriate limits in...