
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.

Successful 510(k) Submissions
John E Lincoln
60 Min
Product Id: 700815
In this 510(k) submission process webinar attendees will learn the different types of 510(k)s, 21 required elements in the traditional 510(k) and how are they addressed and documented. Also attendees will learn software / firmware requirements, De Novo submission for obtaining marketing clearance for medical devices in the U.S.

Japan: Regulatory Compliance Requirements for Life Science Products
Robert J Russell
90 Min
Product Id: 702979
This training on Japanese regulatory compliance requirements will explain the country's regulations and processes (including clinical trials, filings, etc.) and use real world experiences to show how compliance issues are culturally handled for life science products in Japan.

Annex 1 Chapter 6 and its Comparison to Compendial Mandates: What Does It Imply to the Industry
Nissan Cohen
60 Min
Product Id: 706362
Annex 1 is a European mandate for Sterile Products Manufacturing but encompasses many critical utilities including pharmaceutical water. The current version is under revision and may be contrary to some Pharmacopeias. Annex 1 will be enforced by PIC/S, EMEA, and other European regulators. This is a very important subject to anyone manufacturing products either in or for the European market.

Solving Statistical Mysteries - What Does FDA Want?
Ron Snee
90 Min
Product Id: 706371
This webinar provides some practical and useful answers to the question "What Kind of Statistical Methods and Tools Does the FDA Want Pharma to Use?"
FDA’s guidances and regulations have emphasized the use of statistics for many years. Statistical thinking and methods is an integral part of the Jan 2011 FDA Process Validation Guidance. It can be argued that the FDA is looking for the pharma and biotech industries to make even greater use of statistical thinking and methods. Even with this long history, the use of statistics seems to be a source of uncertainty and anxiety for many. This presentation provides an overview of what it appears the FDA is looking for in the use statistics including examples and recommended approaches.

Top Habits of Highly Successful HR Departments
Margie Pacheco Faulk
90 Min
Product Id: 706395
This training will identify the top habits of highly successful HR Departments as well as what happens if these elements are corrupted or missing.

Goal Setting for Management Success
Biagio Sciacca
60 Min
Product Id: 706447
This session will give rise to the participant’s understanding of how goal setting works and how it can be used in a management context. We will also discuss how to track goals for maximum efficiency and other webinars in this series will use the goal setting methodology as a foundation. The webinar will provide a brief description of the definition of SUCCESS and how the scientific goal setting process fits into that definition.

How Can Leaders and HR Professionals Manage the COVID-19 Pandemic in the Workplace -- Impact on Employees’ Employment, Finances, and Emotional Wellbeing
Margie Pacheco Faulk
60 Min
Product Id: 706517
Employers, HR professionals and Leaders are desperate for guidance when it comes to decisions made in the workplace to accommodate our "New Normal" and to adhere to compliance regulations during the COVID-19 Pandemic. When you have different Federal and State requirements regarding the health guidelines and mandates which is critical but, what happens to the workforce?
How should employers change to accommodate the "New Normal" for employees? How should employees be paid when they work remotely, how should employees be laid off (if it comes to that), how should employees be deployed effectively, who should stay on site during the state 25%-30% reduction in the workforce on-site, how to conduct social distancing, the everchanging communications it is not a wonder that we need to ensure our employees and even customers are aware how we will guide them and ourselves to ensure we are providing the necessary leadership to manage this crisis.

How to Create A PMS Plan and Report According to EU MDR 2017/745 Article 83-86?
Frank Stein
90 Min
Product Id: 706533
The new medical device regulation EU MDR 745/2017 in the European Union has a lot of new requirements. One hot topic is the focus on the "Post-Market- Surveillance-Process" and the new requirements e.g. reporting to Competent Authorities and Notified Bodies and how this process is connected to other processes in the quality management system according to ISO 13485:2016. The understanding of these changes and how to implement changes until May 2021 is essential to keep your certificates and to keep the market entry open.

Clinical Study Risk Management including Compliance During The COVID-19
Laura Brown
60 Min
Product Id: 706526
Attend this webinar to understand the key requirements for risk management of clinical trials to comply with the latest focus on GCP inspection in this area including during the challenging environment of COVID-19.