The United States Attorney’s Office, the FBI, Department of Homeland Security, the Seattle Police Department and the Tukwila Police Department invite you to a presentation on the “nuts and bolts” of things to do to protect your Houses of Worship and Community Centers and what to do if an incident happens. We will have speakers talk about security measures, potential criminal laws that apply if something happens and law enforc...

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 prevention, pers...

This seminar focuses on how to establish a systematic approach to pharmaceutical development that is defined by Quality-by-Design (QbD) principles using design of experiments (DOE). In addition, this course teaches the application of statistics for setting specifications, assessing measurement systems (assays), developing a control plan as part of a risk management strategy, and ensuring process control/capability. All concepts are taught with...

Supplier selection and management is one of the critical issues for medical device manufacturers. Suppliers provide materials and services to the device manufacturer, which means that they can be critical to performance and delivery of your device. Neither the FDA nor your notified body regulates your suppliers (with a few exceptions). They expect you to have an effective process to ensure your suppliers perform in the regulatory environment....

Being in compliance with HIPAA involves not only ensuring you provide the appropriate patient rights and controls on your uses and disclosures of protected health information, but you also have the proper policies and procedures in place. If audited or the subject of a compliance review you will be required to show the government you have all the necessary documentation in place for safeguarding patient Protected Health Information and indicat...

Course "Applied Statistics, with Emphasis on Risk Management in R&D, QA/QC, and Manufacturing" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: The 2-day seminar explains how to apply statistics to manage risk in R&D, QA/QC, and Manufacturing, with examples derived mainly from the medical device design/manufacturing industry. The flow of topics ov...

Course "Bullet Proof 510(k) and Latest FDA Proposed Changes to the Process" 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 course is a primer and overview to the premarket notification process, i.e., a 510(k). A 510(k) is a premarket submission made to FDA to demonstrate that your device to be marketed is at least as safe and effective, tha...

Overview: The topics will begin with an introduction into the basic healthcare compliance infrastructure necessary to establish a comprehensive and proactive compliance program. It will progress throughout the sessions to discuss current government auditing agencies and audits that are underway, as well as an in-depth discussion of government agencies responsible for protecting the Medicare Trust Fund from Fraud, Waste and Abuse. Our participa...