Course "Validation and 21 CFR 11 Compliance of Computer Systems: Intermediate to Advanced" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Analytical and other 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 req...

Course "Statistical Process Control & Process Capability" 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 teaches participants the fundamental concepts and methods needed to establish effective control charts and estimate process capability. In addition to learning traditional control charts (e.g. xbar, r/s), participants will be exposed...

Overview: This seminar will show you how to structure and optimize your QMS. It all starts with Management Responsibility and a commitment to quality. We'll discuss the concepts of management responsibility, a culture of quality, and continuous improvement. We'll discuss tools and metrics for understand the state of your QMS and how to identify and prioritize opportunities for improvement. We'll discuss the 4 major Quality System elements that...

Overview: 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 proc...

Overview: The secret is - HIPAA Rules are easy and routine to follow - when they are explained step-by-step in plain language. In this seminar Paul Hales will capture your attention with visual presentations, discussion and learning exercises and show how to find the right rule with the step-by-step procedures you need when you need them. Seminar Takeaways: Thorough Understanding of HIPAA Rules What they are How they work together Why and How...

Overview: Quality control and related contract laboratories are considered at high risk because after testing and approval, drug products and Active Pharmaceutical Ingredients (APIs) are released to the market without further check. That's the reason why the FDA and other agencies put highest emphasis on inspections of QC laboratories. Even though cGMP regulations have been in place since long time, the large number of QC related 483's and war...

Overview: 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, pr...

Design Controls are essential for producing safe and effective medical devices. And Design Controls are considered a critical process by the FDA. Yet is still one of the most frequent areas for 483 and Warning Letter observations. This 2 days seminar will help you understand and develop design controls processes and tools that are a competitive strength for your company. Intrinsic quality, safety, and effectiveness of a device are known to be...

Overview: Transportation and Logistics food transportation food safety rules are currently being finalized by the U.S. Food and Drug Administration (FDA). Under congressional instructions, the Food Safety Modernization Act (FSMA) requires the FDA to establish rules to improve, audit and enforce new food transportation rules. The rules provide a significant focus on foods not completely enclosed by a container, risk reducing adulteration preven...

Course "Validating Radiation Sterilization for Medical Products" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Review of basic polymer chemistry and changes in polymer characteristics can be anticipated and designed for. Learn how to plan for post radiation resistance and lifetime functionality. All radiation modalities (gamma, e-beam, x-ray) will be r...