WEBINARS

 

The Department of Labor's Fiduciary the New Final Rule - Best Practices for Conducting a Due Diligence and Reviewing the Best Interest Contract Exemption

webinar-speaker   Lisa Marsden

webinar-time   60 Min

Product Id: 705021

This 60-minute training session will provide a detailed overview of the Department of Labor’s Final Fiduciary Rule including the history and on-going resistance to the rule. The session will delve into details on how the rule was established and who it will be applied to. The webinar instructor will discuss the summary of the details of the new final rule and what firms must do to comply.

Recording Available

* Per Attendee $179

 

Precision Tools for Error Reduction: Strategies and Implementation Techniques

webinar-speaker   Ginette M Collazo

webinar-time   90 Min

Product Id: 704364

This training program will analyze the factors and causes behind human errors. It will define the process to manage human error deviations and participants will learn about human error measurement. The program will also discuss tools for measurement and Key Performance Indicators (KPIs).

Recording Available

* Per Attendee $179

 

Designing an Effective and Compliant Standard Operating Procedure (SOP) and Standard Test Method (STM)

webinar-speaker   Charity Ogunsanya

webinar-time   90 Min

Product Id: 705018

This webinar training will benefit manufacturers of manufactured products to achieve an effective, robust and compliant SOP and STM which will result in a cost effective and efficient manufacturing and testing of products. A well planned and written SOP or STM will reduce the incidence of out-of-specification (OOS) results, failure, product non-conformances, deviation and invalid assay investigations.

Recording Available

 

Not the Final Frontier: Developing Cultural Competence

webinar-speaker   Jacquiline M Wagner

webinar-time   60 Min

Product Id: 704740

This training program will focus on the value of inviting different perspectives and world views into the workplace, to become culturally competent. It will also explore cultural competence development models and illustrate the U.S. Army’s approach to cultural competency as an example.

Recording Available

 

Compliance with the New EU Clinical Trial Regulation

webinar-speaker   Laura Brown

webinar-time   60 Min

Product Id: 705007

This webinar will provide an essential understanding to help with compliance with the new regulation and associated implementing acts and other texts for carrying out clinical trials in the EU.

Recording Available

 

Physician Recruitment and Onboarding: Key Legal Considerations for Health Systems, Hospitals and Medical Groups

webinar-speaker   Joseph Wolfe

webinar-time   60 Min

Product Id: 704597

This training program will provide a general Stark Law overview and examine critical components of Stark and Anti-Kickback compliant recruitment arrangements such as income and cost allocations, reasonable practice restrictions, repayment requirements, etc. The program will also discuss best practices for drafting physician employment agreements, related compensation plans and facilitating effective onboarding.

Recording Available

* Per Attendee $229

 

Prospects for Change at FDA Under the Trump Administration: Early View of What 2017 Will Bring

webinar-speaker   Steven Grossman

webinar-time   90 Min

Product Id: 705023

This webinar will discuss FDA's current priorities and the agency's likely priorities and the future of regulations and policies in 2017 under the new Trump administration.

Recording Available

* Per Attendee $199

 

How to Implement a Workplace Diversity and Inclusion Program

webinar-speaker   Catherine Mattice Zundel

webinar-time   90 Min

Product Id: 705017

A common workplace discussion often centers around diversity and inclusion and why it should be celebrated. This training program will discuss creating a strategic plan for diversity and inclusion. It will detail building an audit plan and auditing your HR department in order to determine opportunities for improvement.

Recording Available

* Per Attendee $229

 

Metrics and Dashboards for Quality and Compliance

webinar-speaker   Susanne Manz

webinar-time   90 Min

Product Id: 703928

This training program will discuss the challenges faced by medical device companies amid close scrutiny by industry regulators. It will also offer best practices for combating lack of transparency in quality/compliance data.

Recording Available

* Per Attendee $50

 

What are ACH Payments, How Do They Work and What Does That Mean - Essentials of ACH Payments

webinar-speaker   Donna K Olheiser

webinar-time   90 Min

Product Id: 704281

This training program will help attendees identify what is the ACH network and examples of ACH electronic payments. It will list the five basic participants in each electronic ACH transaction and describe the settlement process and the difference between a debit and a credit ACH transaction.

Recording Available

* Per Attendee $179

 

Why I should test raw materials for microbial presence and what is the microbiological and business risk if I choose not to?

webinar-speaker   Henry Urbach

webinar-time   90 Min

Product Id: 703058

This webinar on biopharmaceutical raw material testing will discuss how to implement processes for the control of microbial contamination, establish microbial limits and mitigate the risk of contamination.

Recording Available

* Per Attendee $199

 

Effective Deviation Investigators Under GMP

webinar-speaker   David L Chesney

webinar-time   120 Min

Product Id: 704974

This 120 minute training course will help attendees understand the fundamental steps of a deviation investigation with focus on using facts and objective evidence to arrive at root cause and CAPA. Learn how to identify and avoid potential pitfalls during deviation investigations.

Recording Available

* Per Attendee $229

 

Navigating the variations in state food regulatory structure

webinar-speaker   Darin Detwiler

webinar-time   90 Min

Product Id: 705006

This course is designed to bring food industry leaders up to speed with the latest research in states’ food regulatory characteristics. The goal is to enable industry leaders to better understand and navigate through the state-by-state nuances.

Recording Available

 

Compliance with the New ICH GCP revised 2 Guidelines

webinar-speaker   Laura Brown

webinar-time   60 Min

Product Id: 704989

This New ICH GCP E6 Revision 2 changes will cover those new requirements for running clinical trials, evaluate the changes and discuss how to implement these for sponsors, CROs and study sites. This session will enable you to meet the new international GCP standard to ensure the acceptance of clinical trial data by the regulatory authorities internationally including the European Union (EU), Japan, the United States, Canada and Switzerland.

Recording Available

 

The 21 Elements of a 510(k)

webinar-speaker   John E Lincoln

webinar-time   90 Min

Product Id: 702323

This webinar will provide valuable guidance to regulated companies in development and implementation of formal, defined, documented methods for analysis of product requirements and documentation necessary to file a 510(k). The 510(k), in any of its three allowable formats, with up to 21 required elements. A brief discussion of how to address device changes and when to file a new 510(k). Consideration of the U.S. FDA's current K-97-1 Memo / guidance document on 510(k) Device Modifications: Deciding When to submit a 510(k) for a Change to an Existing Device, to provide tools to document such decisions.

Recording Available

* Per Attendee $279

 

Detailing Transportation Fringe Benefits

webinar-speaker   Vicki M. Lambert

webinar-time   90 Min

Product Id: 705003

This training program will discuss the taxation of different types of fringe benefits related to transportation including the personal use of a company car, proper accounting and taxation of auto allowances, personal use of a company aircraft, and the IRS 132 fringe benefits such as parking and mass transit passes.

Recording Available

* Per Attendee $299

 

Using the ISP98 Model Forms for Standby Letters of Credit

webinar-speaker   Buddy Baker

webinar-time   90 Min

Product Id: 702830

This training on Letters of Credit will walk you through the ISP98 Model Forms, explain variations and show how you can adapt them to structure standby letters of credit that comply with the provisions of the ISP98.

Recording Available

* Per Attendee $249

 

The Essentials of Third Party Sick Pay: What Payroll Must know to Tax and Report Correctly

webinar-speaker   Vicki M. Lambert

webinar-time   90 Min

Product Id: 704992

This webinar will discuss proper taxation and reporting of the fringe benefit known as third party sick pay. It will discuss what is and is not third party sick pay, how the taxation is affected by the status of the provider (who is or is not the employer’s agent), when this type of payment is taxable and/or reportable, and who is responsible for this taxation and reporting.

Recording Available

* Per Attendee $299

 

Data Analysis in QSR

webinar-speaker   Daniel O Leary

webinar-time   90 Min

Product Id: 704990

Data analysis is one of the most powerful improvement tools because it can lead to cost reductions and preventive action. To use these techniques you need to know both the regulatory requirements and the analysis framework. This webinar gives you the tools and techniques to implement an effective data analysis program.

Recording Available

 

Russia: Compliance Processes and Regulations

webinar-speaker   Robert J Russell

webinar-time   90 Min

Product Id: 703870

This training course will provide a detailed overview of the regulatory requirements, local challenges and important cultural aspects of working with the lifecycle of life science products (pharmaceuticals, medical devices, biologics and combination products) as an importer or producer in Russia. It will offer a deeper understanding of cultural norms, and will discuss best practices for establishing relationships and protecting your intellectual property to be integrated into your company’s training and corporate business strategies.

Recording Available

* Per Attendee $249

 

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