WEBINARS

 

Compliance Training Webinars for Regulated Industries

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Attaining Your CE Mark for Your Medical Device in the EU

webinar-speaker   Charles H Paul

webinar-time   60 Min

Product Id: 706543

The letters ‘CE’ appear on many products that are traded on the single market in the European Economic Area (EEA). By placing the CE mark on a product, a manufacturer is declaring, on his sole responsibility, conformity with all of the legal requirements necessary to achieve CE marking status. With that mark, the manufacturer is ensuring validity for that product to be sold throughout the EEA. CE marking does not mean that a product was made in the EEA, but states that the product is assessed before being placed on the market. It means the product satisfies the legislative requirements to be sold there.

Recording Available

 

Service Level Agreements (SLAs) - Preparation Guidelines for Effective SLAs

webinar-speaker   Javier Kuong

webinar-time   120 Min

Product Id: 700485

This 2-hr webinar on Service Level Agreements (SLAs) will provide you with sound principles and a set of guidelines for developing and preparing ‘effective’ Service Level Agreements (SLAs) for an internal service function or an outside service provider.

Recording Available

* Per Attendee $239

 

Leveraging Metadata for SDTM Automation and Compliance

webinar-speaker   Sunil Gupta

webinar-time   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.

Recording Available

 

Leave in the Time of COVID: Navigating Employee Leave Under FFCRA, FMLA, ADA and Workers' Comp

webinar-speaker   Janette Levey Frisch

webinar-time   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.

Recording Available

 

Reshoring American Manufacturing in the Era of COVID-19

webinar-speaker   William Levinson

webinar-time   90 Min

Product Id: 706570

The United States' loss of manufacturing capability in the past decades has led to a decline in the nation's standard of living, and has also weakened its geopolitical strength. The COVID-19 outbreak has meanwhile underscored the vulnerabilities of extensive supply chains that include unreliable trading partners. Proven off-the-shelf methods and principles are however available to rebuild the United States' manufacturing capability and make it more profitable for all stakeholders.

Recording Available

 

Mission Possible: How to Obtain A Zero Injury Culture In The Workplace

webinar-speaker   Michael Aust

webinar-time   60 Min

Product Id: 704739

This zero tolerance for injuries training program will discuss what it means to have a safety culture on site. It will also identify the four steps of the safety maturity curve and discuss employee and employer rights and responsibilities at each step of the maturity curve. The instructor will explain the benefits of sustaining a safety culture in the workplace.

Recording Available

* Per Attendee $299

 

The ABC's of Processing ACH Exceptions (Returns)

webinar-speaker   Donna K Olheiser

webinar-time   90 Min

Product Id: 705353

Have you struggled with the question - “When do I use a Stop Pay form and when do I need a Written Statement of Unauthorized Debit (WSUD)?” This is YOUR session! The trainer in this session will provide examples of when to use which form and why plus tying this information back to what the NACHA Operating Rules state to ensure you are in compliance each time you help your account holder with their request. With the newly adopted Rules change for 2020 with “unauthorized returns” what Return Reason code do I use and why? Return Reason Code R10 or R11 and what is the difference when using these to return Entries as unauthorized? Key points illustrated during this virtual workshop will assist your customer service and front-line staff as well as your operations staff.

Recording Available

* Per Attendee $249

 

HR Audits: Identifying and Managing What Happens Next as the Result of Pandemic

webinar-speaker   Ronald Adler

webinar-time   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.

Recording Available

* Per Attendee $249

 

Master Advanced ICD-10-CM Concepts and Prevent Coding Errors

webinar-speaker   Victoria M Hernandez

webinar-time   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).

Recording Available

 

Training and Development in The Life Sciences - Build Training That Works

webinar-speaker   Charles H Paul

webinar-time   60 Min

Product Id: 706542

This webinar will explore the area of training in regulated environments, its importance, and its relationship to compliance documentation. You will learn how to achieve world-class compliance, improved operational performance, improved quality, and improved employee/associate safety through training.

Recording Available

 

Constructing a Benefit-Risk Analysis

webinar-speaker   Don Hurd

webinar-time   60 Min

Product Id: 706571

ISO 14971:2019 requires an overall Benefit-Risk Analysis but many companies struggle with constructing the rationale for demonstrating overall benefits outweigh overall risks. This webinar will provide one systematic approach which has proved successful for approaching the analysis.

Recording Available

 

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

webinar-speaker   Karl M. Nobert

webinar-time   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.

Recording Available

* Per Attendee $399

 

The Nutraceutical / Dietary Supplements CGMPs per 21 CFR 111

webinar-speaker   John E Lincoln

webinar-time   60 Min

Product Id: 706360

This webinar will evaluate the chief areas of the Dietary Supplements FDA CGMP compliance requirements as required by in 21 CFR 111, the US Law – this and related regulations mandate a ‘total quality system’ -- from customer requirements thru development, production, to customer use/feedback. Labeling requirements will also be discussed, including those uniquely geared to nutraceuticals. The steps resulting in the present FDA regulatory requirements will be reviewed. This webinar can also be a significant part of meeting a company’s annual CGMP training requirement (if properly supplemented and documented) for a neutraceutical company.

Recording Available

 

US FDA's Plan for Modernizing the 510(k) Pathway - Meet the New Expectations

webinar-speaker   John E Lincoln

webinar-time   90 Min

Product Id: 706580

Almost two years ago the US FDA announced new steps necessary to modernize FDA’s 510(k) clearance pathway, but companies have been slow to respond, leading to unnecessary delay in achieving marketing clearance. This was reiterated one year ago in the FDA’s Medical Device Safety Action Plan and the related Draft Guidance Document. These steps are viewed by the Agency as a top priority, and provide insight into the Agency’s thinking about what a 510(k) could do to advance medical benefits to the patient.

Recording Available

* Per Attendee $299

 

Outlook: Master Your Mailbox - Inbox Hero Inbox Zero

webinar-speaker   Mike Thomas

webinar-time   60 Min

Product Id: 705589

This training session focuses on the email aspect of Outlook. In this session you'll learn how, used in the right way, Outlook can save you time, help you to gain more control over your mailbox, improve your response time and allow you to keep up with the never-ending stream of critical actions and due dates.

Recording Available

* Per Attendee $199

 

Measuring Risk from Financial Statements

webinar-speaker   Fred Vacelet

webinar-time   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?

Recording Available

 

5 Hr Virtual Seminar on The Interplay of the Americans With Disabilities Act, the Family and Medical Leave Act, and Workers’ Compensation

webinar-speaker   Diane L Dee

webinar-time   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.

Recording Available

* Per Attendee $499

 

Employee Handbooks: Key issues Post Pandemic

webinar-speaker   Ronald Adler

webinar-time   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.

Recording Available

* Per Attendee $249

 

Developing and Implementing an Effective Regulatory Tracking Process

webinar-speaker   Mario Mosse

webinar-time   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.

Recording Available

* Per Attendee $249

 

The Role of The Scheduler - Before, During and After

webinar-speaker   Jim Zack

webinar-time   90 Min

Product Id: 705508

This webinar identifies what a schedule is; what a scheduler should be; whose schedule it is; and, why many project schedules fail. The webinar also explores the role of a competent project scheduler during the planning, the scheduling, the closeout and, the forensic scheduling phases of a project.

Recording Available

* Per Attendee $249

 

 

 

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