Course "Best Practices for Safety Reporting in Clinical Trials for Drugs, Biologics and Medical Devices" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. GlobalCompliancePanel Refer a Friend Program: Any Customer to 3 Referrals "Can Participate 2 Days Seminar for free of Cost Overview: The Food and Drug Administration's Center for Drug Evaluation Research, Center f...

This course provides an overview of internal auditing requirements and techniques for medical device companies as a method for risk management and quality improvement.The course will cover auditing requirements, audit planning, preparation, knowledge, auditor skills, interviews, documents and records review, objective evidence, audit report writing and corrective action.Why should you attend?Attendees should attend this seminar for risk manage...

The Food and Drug Administration's Center for Drug Evaluation Research, Center for Biologics Evaluation Research and Center for Devices and Radiological Health are responsible for the approval of drug products, biologics and medical devices industries. This seminar begins with outlining the structural role of the FDA and a brief introduction to the Food, Drug and Cosmetic Act (the ACT) and how the FDA uses it to enforce the regulatory requirem...

This seminar is organized according to logical, sequential phases of a pay project. Each phase is subdivided into specific considerations or tasks, followed by a series of questions to help you analyze your situation. Exercises and examples are used to bring many of the considerations into tangible form. "How to" is what this seminar is all about. The field of pay management already has plenty of theoretical texts and you should read them too....

Course "Mastering the HIPAA Privacy, Security, and Breach Notification Rules: Coping with Rule Changes, Managing Incidents, Preparing for Audits, and Avoiding Penalties" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. GlobalCompliancePanel Refer a Friend Program: Any Customer to 3 Referrals "Can Participate 2 Days Seminar for free of Cost Overview: This session is...

Course "Risk Analysis and Design of Experiments (DOE) in Process Validation and Development" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. GlobalCompliancePanel Refer a Friend Program: Any Customer to 3 Referrals "Can Participate 2 Days Seminar for free of Cost Overview: This course is designed to help scientists and engineers plan and conduct experiments and an...

This course is designed to help scientists and engineers plan and conduct experiments and analyze the data to develop predictive models used to optimize processes and products and solve complex problems. DOE is an extremely efficient method to understand which variables (and interactions) affect key outcomes and allows the development of mathematical models used to optimize process and product performance. The models also provide an understand...

Overview:Writing SOPs or procedural documents can be challenging at times. However, writing SOPs is overall a straightforward process. However, enforcing what you already created and implemented in the pipeline is another story. The term SOP is very obvious. We have seen "clearly written description of how specific tasks are to be done." Another satisfactory definition would be "detailed written instructions that achieve the uniformity of the...

This will be an all-inclusive class that give details on understanding the laws such as FLSA and other laws such as the portal to portal act that help payroll professionals determine proper pay methods. Once the correct pay method is determined this class will give the skills to understand how to properly calculate overtime pay accurately according to FLSA guidelines for all types of payrolls. The assist in the learning process case studies wi...

This course covers a very broad range of topics from worker classification, to employee classification, to establishing methods and rates of pay, what must be included in the rate of pay, hours that must be compensated as worked time, required benefits, de minimus working fringes, withholdings and deductions from pay, voluntary deductions, child support and garnishment orders, payroll reporting, analysis of risks of noncompliance, proper docum...