Spotlight on Complaint Handling and Medical Device Reporting
Susanne Manz
90 Min
Product Id: 706099
This webinar will help you to understand the expectations of complaint handling and medical device reporting. You’ll also learn about lessons from 483s and warning letters. We’ll discuss how you can develop your processes to efficiently and effectively manage complaints and MDRs. Also, we’ll discuss how to link these processes to failure investigation, recalls, and CAPA (Corrective and Preventive Action). We’ll cover best practices, so you can be prepared for an FDA inspection.
Compliance Management - Introduction; Laws and Regulations
Stanley Epstein
90 Min
Product Id: 706544
Creating a culture of compliance is an important risk management strategy. Recent corporate collapses have reflected the need for good corporate governance and an effective compliance program is an integral part of this structure. This introduction to Compliance Management provides a blueprint for compliance professionals to follow to ensure that the risk profile in his/her organization is limited by a thorough understanding of the individual regulatory environment.
Will your food fraud vulnerability assessment pass an audit?
Karen Everstine
60 Min
Product Id: 706066
The webinar will provide you with valuable information about setting up a food fraud vulnerability assessment so that you are better prepared to meet the food fraud-related requirements of GFSI Certification Programme Owners and the economically motivated adulteration requirements of the U.S. Food Safety Modernization Act.
FDA Design and Document Change Control
Denise Arrington
90 Min
Product Id: 706555
Learn about change control process and procedures in regulated industries. This webinar help you understand and successfully apply change control steps and best practices.
Best Practices for Setting Up a Global International Trade Compliance Program
Deep SenGupta
60 Min
Product Id: 703708
Attend this webinar to learn how to evaluate the trade compliance risk for your worldwide subsidiaries and how to ensure that your worldwide subsidiaries are adequately managing their trade compliance risk.
Aligning Individuals Who Have Competing Priorities
Madonna Swanson
60 Min
Product Id: 706405
This webinar will provide practical learning for implementing design thinking principles into your meeting management techniques. Learn how to facilitate interactive meetings which motivate teams to quick alignment. Understand how to “group” synthesized data for buy in from all parties.
SR Letter 11-7 - Supervisory Guidance on Model Risk Management
Mario Mosse
90 Min
Product Id: 703995
This training program will detail why SR Letter 11-7 has become the gold standard for model risk management, with its principle being adopted not only by banks but also virtually all U.S. financial institutions.
Audit 3.0: Audit/Auditing Fundamentals for the 21st Century
James W Monroe
60 Min
Product Id: 706495
Whether you are being audited or conducting and audit, understanding the fundamental is critical for both quality system and regulatory compliance. In this webinar we will examine the concepts of conducting audits and being the subject of an audit (internal or external).
Managing Patients with an Extended Length of Stay
Bev Cunningham
60 Min
Product Id: 706541
This webinar will focus on the challenge of the patient with an extended length of stay. It will focus on characteristics that can assist hospital case management staff in identifying patients that are potential candidates for extended length of stay, with strategic interventions to decrease both the number of patients in this group and a decrease in the length of stay of any patient reaching extended length of stay.
Risk and Forecasting Systems, Beyond Gaussian Wisdom
Fred Vacelet
90 Min
Product Id: 706534
For as long as can be remembered, financial markets have thrived under the following paradigm: if we do not know future prices, then they must be stochastically determined, therefore Gaussian mathematics is the tool to use. In this webinar, we address the questions: where does this reflex come from? How sure can we be? Are there no other ways?
Weed, Cocaine and Heroin: What it Means to Your Bank or Credit Union?
Doug Keipper
60 Min
Product Id: 705440
This webinar will focus on the today’s marketplace for weed, cocaine and opioids including heroin. It will cover topics such as FinCEN’s expectations regarding Marijuana-related businesses, drug enforcement agency fact sheets, FBI and DEA documentary on opioid abuse, summary review of transactions and much more.
Coronavirus and a New Member of This Family (COVID-19) - What You Need to Know
Dr. Afsaneh Motamed Khorasani
90 Min
Product Id: 706525
There is a lot of information circulating online about COVID-19 and there is a lot of confusion around what will happen to individuals, what this new enemy is that has suddenly appeared in our midst, interrupted/threatened our lives and what to do to stay safe. The goal of this webinar it to provide clear information to demystify COVID-19 and provide a platform to answer questions. The content is scientific in nature but simplified for people so that people without a strong scientific background can understand the content.
Motivating Staff to Avoid Compliance Breaches
Jack Bensimon
60 Min
Product Id: 706228
This webinar will discuss ways to develop rewards and deterrence strategy to ensure staff are effectively motivated to comply with the firm’s policies & procedures. It’s often a matter of clarifying for staff what is expected of them to tailor their job, and how best they can satisfy compliance requirements without compromising their own performance. The goal is to turn this into a crusade without staff believing it to be so.
The Mindset of an FDA Employee
Larry Stevens
60 Min
Product Id: 706174
If you develop or manufacture a product regulated by FDA you will need to interact with FDA employees. It is important to interact with the FDA employee in the most productive manner. But there is a variable you must deal with that will determine how productive your interaction is. The variable is the FDA employee. That is the purpose of this webinar.
Conducting Remote Job Interviews: Considerations for Candidates and Companies
Norman Baker
60 Min
Product Id: 706540
This course provides insights and best practices for both candidates and interviewer(s) for conducting remote job interviews. Covid-19 has greatly enhanced the need for remote interviews but even prior to and after social distancing guidelines subside, there are numerous circumstances when remote interviews are appropriate.
Leverage Regulatory Documentation - Write SOPs That Work and Have Value
Charles H Paul
60 Min
Product Id: 706530
Compliance documentation to include Standard Operating Procedures – the documentation required by regulation – is essential to the effective and compliant running of any regulated business. Unfortunately, many individuals in those businesses miss the valuable opportunities that properly developed Standard Operating Procedures/Work Instructions can provide. Regulated documentation can serve a variety of purposes other than meeting a regulatory requirement – as training materials, to standardize operations, to manage individual and group performance, to identify the sources of deviations, etc. The key is to knowing how to write those documents to properly meet those needs.
Adopting Strategic Risk Management to Achieve Effective Enterprise Governance, Compliance and Reduce Corporate Exposure
Javier Kuong
120 Min
Product Id: 706264
The webinar focuses on a modern approach to practice “Strategic and Top-down” Risk Management (SRM) that is anticipatory and preventive in nature that can materially contribute to pave the way for organizations to meet their strategic goals and “business” objectives that benefit the entire organization.
Auditing Information Security Using ISO 27001
Michael C Redmond
60 Min
Product Id: 705910
This ISO 27001 webinar will help you to audit your program in relation to establishing, implementing, operating, monitoring, reviewing, maintaining and improving an information security management system and we will also discuss which standards to reference to effectively ensure your organization has a robust security program for your organization's vital information assets.
Import and Export - Improving Your International Trade Compliance Score
Deep SenGupta
60 Min
Product Id: 703961
This international trade compliance training program will evaluate strategies such as drawback, foreign trade zones or free trade agreements. It will also offer guidance and best practice strategies for several import/export practices such as methodology for measuring trade compliance score, and determining export control classification number.
Sample Re-Analysis: Considerations for Incurred, Analytical and Pre-analytical requirements
Edward O Connor
60 Min
Product Id: 706498
Sample re-analysis can be a quagmire of decision and indecision. Incurred sample re-analysis is required in regulated labs, but resolution of disparate results can be another difficult area. Pre-analytical issues- including mislabeling or absent sample as well as analytical issues add a measure of difficulty as well. This presentation will address these issues and help formulate acceptable resolutions.