This workshop style training course is designed based on 30 year of regulatory affairs experience in preparing more than 150 successful U.S. FDA submissions for major medical device companies. In these 2 days, the following essential elements of U.S FDA premarket submissions will be covered: History and background of U.S FDA Laws and Regulations Classify Your Device Choose the Correct Premarket Submission for your device Compile the Appropriat...

The Department of Homeland Security invites you to participate in an in-person demonstration of the new Chemical Facility Anti-Terrorism Standard (CFATS) Chemical Security Assessment Tool (CSAT) 2.0. This demonstration will walk users through the revised CSAT portal user interface and streamline Top-Screen, Security Vulnerability Assessment (SVA), and Site Security Plan (SSP) surveys being released this fall. These demonstrations will also pro...

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...

Overview: A detailed look at each section of the standard. Real world examples of what to expect, and what to prepare and repeal within the audit guidelines. What must a documentation system look and feel like to ensure compliance? These and many other key details to ensure that your organization has the ability and knowledge to ensure that ISO 13485 is within your grasp. Clean rooms 101, we can assist in what to do and what not to do. From th...

Overview: HR audits are designed to help your organization focus its attention on its human resource management practices, policies, procedures, processes, and outcomes by providing you with a structured and systematic series of questions about key compliance, risk management, internal auditing, and human resource management issues. As a process, HR audits are designed to help your organization identify potential and actual problem areas, help...

Overview: We engage most of your senses. You will read short lessons, write action plans, discuss issues with others, ask questions and provide answers as well as make and keep commitments to yourself and the group. Focus is on five basic skills: goal clarity, team building, personal organization, communication and increased productivity. Its fun, fast paced and you will be delighted with your growth. This is not sitting for hours and listenin...

Cyber attacks on corporations, governmental agencies and individuals are becoming increasingly widespread and regular, as well as more complex. In honor of National Cyber Security Awareness Month, LMU is once again hosting The Third Annual Cybersecurity Summit that brings together government officials, private business executives and cybersecurity experts to discuss the current and emerging threats that exist in today’s sophisticated cyb...

Government Technology’s passion is helping spread best practices and spurring innovation in the public sector. The Los Angeles Digital Government Summit is designed to do just that. The summit has an advisory board that gathers public sector and private sector leaders to create an agenda designed to make that passion relevant and actionable to the state and local government organizations attending the summit. Participants tell us they us...