Implementing Operations Risk Management within an ERM Framework
Mario Mosse
90 Min
Product Id: 703728
Sound management of operational risk is an integral part of strong governance, risk and compliance (GRC) and enterprise risk management. In this session, the instructor will define operational risk and explain how to identify, quantify, manage, and control it. He will discuss why all employees must be cognizant of these risks in their day to day jobs and how an organization can better manage and control these risks that have resulted in the failure of several high profile firms and significant losses and unwanted press at others. The course will also review and discuss the building blocks and key players in implementing an effective ORM program that is integrated into the enterprise risk management framework.
Veterinary Medical Devices and FDA’s Regulatory Oversight
Karl M. Nobert
60 Min
Product Id: 703769
This webinar will make your understand regulatory requirements of veterinary medical device. How to differentiate regulations of human and veterinary medical devices, manufacturing requirements, safety standards, labelling requirements, how to draft the SOPs covering material intake, production, quality control, packing, distribution and sales.
Leveraging Metadata for SDTM Automation and Compliance
Sunil Gupta
90 Min
Product Id: 706569
This presentation reviews the six levels of metdata level processing that all organizations need to be aware of and plan for. In the current days of automation in our daily lives at home, in the car and in various industries, FDA submissions in the pharma industry is next in line for more automation through metadata. We will explore examples for each of the metadata level. Metadata will be reviewed to understand how metadata has answers to key questions for logical processing. SAS tools will be reviewed to write code for more automation process.
Leave in the Time of COVID: Navigating Employee Leave Under FFCRA, FMLA, ADA and Workers' Comp
Janette Levey Frisch
90 Min
Product Id: 706583
In addition to the FMLA and the ADA, now we have the Families First Coronavirus Response Act (FFCRA), mandating paid leave for many employees for COVID-related reasons. In this webinar, we will discuss key, hot-button compliance issues and share some Best Practices for managing a workforce while staying in compliance with the FFCRA, the FMLA, ADA, and Workers’ Comp.
HR Audits: Identifying and Managing What Happens Next as the Result of Pandemic
Ronald Adler
90 Min
Product Id: 703882
This HR Audit webinar will cover key strategic, operational, and compliance HR management issues. The objective is to provide the attendee with the key areas that should be addressed in conducting an HR audit, an understanding of critical tasks to be completed, and an update how federal and state employment laws may affect the scope and the reporting of the HR audit.
Master Advanced ICD-10-CM Concepts and Prevent Coding Errors
Victoria M Hernandez
60 Min
Product Id: 706097
This ICD-10-CM webinar will cover day-to-day complex challenges for coding professionals and CDI professionals, which includes advanced areas of the coding guidelines, coding conventions, strategies to address documentation issues and query best practices. It will also review challenging CDI, coding and audit case scenarios and review query examples, coding references and clinical indicators on common diagnoses considered as complications/comorbidities (CC) and major complications/comorbidities (MCC).
An Introduction to FDA's Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (''HCT/Ps'') including Stem Cell-Based Drug Products for Human Use
Karl M. Nobert
90 Min
Product Id: 701927
This webinar will review FDA's regulatory oversight of stem cell-based products when used in humans and analyze its potential impact on the industry in the future. Learn FDA's criteria for marketing and promotion of stem cell-based products for therapeutic application.
Measuring Risk from Financial Statements
Fred Vacelet
60 Min
Product Id: 706568
For external analysts, financial statements are a key source of information for getting an understanding of how risk a financial institution can be. Yet, still too many people are tempted to think that financial statements are designed to provide a true and fair view on risks. Do we know how much of the risks are genuinely communicated via financial statements?
5 Hr Virtual Seminar on The Interplay of the Americans With Disabilities Act, the Family and Medical Leave Act, and Workers’ Compensation
Diane L Dee
5 Hrs
Product Id: 706122
Attend this webinar to gain a clear understanding of the Americans with Disabilities Act (ADA), The Family and Medical Leave Act of 1973 (FMLA), and Workers’ Compensation laws and how they interact with each other. Learn how to incorporate that information into company policies and develop the ability to communicate those policies to employees.
Employee Handbooks: Key issues Post Pandemic
Ronald Adler
90 Min
Product Id: 703910
This webinar discusses the key employment policies that should be incorporated in every employee handbook. The webinar further identifies policies statements that add value to the employer-employee relationship and discusses key issues that will require inclusion in the future.
Developing and Implementing an Effective Regulatory Tracking Process
Mario Mosse
90 Min
Product Id: 705993
This webinar will prepare participants to build a legislative and regulatory tracking process that monitors regulatory change, measures impact on business operations, and ensures the implementation of appropriate policy, training, and control updates.
Why Management System Audit Programs Should Utilize ISO 19011
Robert Davis
60 Min
Product Id: 706574
An audit function should be thought of and managed as an independent business, including stakeholder analysis and feedback, setting objectives, developing necessary processes for managing resources and risks, measuring and improving performance, and even marketing to potential customers. This webinar covers topics specifically related to the audit system. How professional judgment and intent need consideration, auditing risks, and how entity life-cycles can affect audits are vital areas addressed during the webinar.
Risk Management for Human Resources
Greg Chartier
90 Min
Product Id: 706562
This program will follow the risk management process described by the International Organization for Standardization (ISO), which sees risk management as a strategic and enterprise challenge. Like strategic planning and management, risk management is cyclical and must constantly be reassessed, evaluated against changing conditions and improved.
HR Metrics and Analytics 2020: Update on Strategic Planning, Application Activities and Operational Impact
Ronald Adler
90 Min
Product Id: 706218
This new 2020 HR Metrics session reviews the utilization of HR metrics and analytics as a core competency, reviews the role HR metrics play in helping the organization make critical business decisions, describes the calculation of employment practices liability risk exposure, and provides a listing of some of the more widely used HR metrics.
How to Analyze Financial Statements
Miles Hutchinson
120 Min
Product Id: 706549
Learn how to analyze the numbers and use this intel to juice up virtually every facet of your organization’s operations from sales and marketing, to finance, HR, and customer service. Use our proven model to quickly assess the financial condition and results of operations of any business using trend and ratio analysis. Join C-suites and business analysts from around the country and empower your team to maximize the benefit from your crystal clear understanding of the numbers. If you are interested in understanding the numbers and have basic grasp of excel, you will enjoy and benefit from this course.
Implementation and Management of GMP Data Integrity
Danielle DeLucy
90 Min
Product Id: 705029
Attend this webinar to learn the regulatory expectations for data integrity during CGMP inspections. The course will review examples of data integrity pitfalls, part 11 compliance data integrity issues, FDA citations related to data integrity. It will teach you how to improve data integrity in a laboratory environment.
FDA Inspections: Anticipation, Preparation, Reaction, Conclusion…Repeat
John Misock
120 Min
Product Id: 706557
FDA regulated industries can prophet by understanding the regulatory power of FDA and incorporating this knowledge into their daily routine. Time and resources spent preparing for the inevitable inspection will pay back proportionately. By doing your homework and putting simple principles to work you can minimize the negative effects of FDA’s power and put everyone in your organization at ease. By understanding the risks inherent in your products, you can develop a quality system that will align your operation with FDA’s expectations. Why live in fear when you can rest at night knowing you are ready?
Drug Manufacturing Inspection Part III
Vanessa Lopez
120 Min
Product Id: 706259
Attend this course to prepare for and understand what will happen during a Drug Manufacturing Inspection for Surveillance Inspections. It will explain the FDA criteria to perform a For Cause Inspection.
Integrating Cyber Risks in the ERM Plan
Mario Mosse
90 Min
Product Id: 706035
You need to protect your information technology assets and information against unauthorized internal or external access and cyber-attacks. Data destruction, alteration, unavailability or breach of confidentiality are the consequences of such attacks. A primary step toward inventorying, assessing, and addressing cyber risks that threaten your organization is to develop and maintain a cyber risk management program as part of your enterprise risk management framework. This presentation will help in developing your organization's risk profile and decide the action plans to mitigate those risks.
Transforming Change and Conflict into Diverse-Inclusive-Collaborative Teaming: The Art of Resilience, Relating & Risk-Taking
Mark Gorkin
60 Min
Product Id: 706553
In a 24/7, rapidly changing, always on, "do more with less" world, not surprisingly, individual stress and interpersonal tension can influence the organizational climate, communication, and coordination. The challenge becomes sustaining resilience and morale while forging cooperative and productive working relationships and partnerships.







