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Home › Online Training ›  Regulatory Affairs

Regulatory Affairs Training - Live Webinars, Recordings & CDs

Hundreds of regulatory affairs specialists each year use ComplianceOnline courses to learn skills and get a clear understanding of specific regulatory requirements needed to succeed in their role. On this page, you will find a broad range of courses specially designed for you. Whether you work in the pharmaceutical, medical device, and equipment, biotechnology, cosmetics, research, or regulatory agencies, or within legal, marketing, and scientific consulting firms, you can get acquainted with the regulatory requirements and guidance for your industry. With the knowledge you gain, you will learn how to apply the regulations in a compliant manner into the actual materials that your company manufactures. You will be in a better position to understand the risks your organization faces. You will get a robust understanding of compliance within the scope of your duties. With the knowledge you gain, you can evaluate current practices and make improvements where necessary. Join them!
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Recorded/CD
Seeking Civility? Understanding and Eradicating Workplace Bullying

Seeking Civility? Understanding and Eradicating Workplace Bullying

  • Speaker: Catherine Mattice Zundel
  • Product ID: 705000
  • Duration: 75 Min
This training program will discuss the definition of workplace bullying and detail strategies to implement a corporate policy that gets buy-in from employees. It will also discuss how to empower employees, supervisors and managers to prevent bullying and offer a wide perspective on regulatory updates on workplace bullying.
CD/Recorded
$0
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Recorded/CD
The Department of Labor's Fiduciary the New Final Rule - Best Practices for Conducting a Due Diligence and Reviewing the Best Interest Contract Exemption

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

  • Speaker: Lisa Marsden
  • Product ID: 705021
  • Duration: 60 Min
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.
CD/Recorded
$179
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Recorded/CD
Precision Tools for Error Reduction: Strategies and Implementation Techniques

Precision Tools for Error Reduction: Strategies and Implementation Techniques

  • Speaker: Ginette M Collazo
  • Product ID: 704364
  • Duration: 90 Min
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).
CD/Recorded
$179
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Recorded/CD
Designing an Effective and Compliant Standard Operating Procedure (SOP) and Standard Test Method (STM)

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

  • Speaker: Charity Ogunsanya
  • Product ID: 705018
  • Duration: 90 Min
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.
CD/Recorded
$0
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Recorded/CD
Not the Final Frontier: Developing Cultural Competence

Not the Final Frontier: Developing Cultural Competence

  • Speaker: Jacquiline M Wagner
  • Product ID: 704740
  • Duration: 60 Min
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.
CD/Recorded
$0
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Recorded/CD
Compliance with the New EU Clinical Trial Regulation

Compliance with the New EU Clinical Trial Regulation

  • Speaker: Laura Brown
  • Product ID: 705007
  • Duration: 60 Min
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.
CD/Recorded
$0
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Recorded/CD
Physician Recruitment and Onboarding: Key Legal Considerations for Health Systems, Hospitals and Medical Groups

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

  • Speaker: Joseph Wolfe
  • Product ID: 704597
  • Duration: 60 Min
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.
CD/Recorded
$229
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Recorded/CD
Prospects for Change at FDA Under the Trump Administration: Early View of What 2017 Will Bring

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

  • Speaker: Steven Grossman
  • Product ID: 705023
  • Duration: 90 Min
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.
CD/Recorded
$199
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Recorded/CD
How to Implement a Workplace Diversity and Inclusion Program

How to Implement a Workplace Diversity and Inclusion Program

  • Speaker: Catherine Mattice Zundel
  • Product ID: 705017
  • Duration: 90 Min
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.
CD/Recorded
$229
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Recorded/CD
Metrics and Dashboards for Quality and Compliance

Metrics and Dashboards for Quality and Compliance

  • Speaker: Susanne Manz
  • Product ID: 703928
  • Duration: 90 Min
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.
CD/Recorded
$50
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Recorded/CD
What are ACH Payments, How Do They Work and What Does That Mean - Essentials of ACH Payments

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

  • Speaker: Donna K Olheiser
  • Product ID: 704281
  • Duration: 90 Min
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.
CD/Recorded
$179
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Recorded/CD
Why I should test raw materials for microbial presence and what is the microbiological and business risk if I choose not to?

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

  • Speaker: Henry Urbach
  • Product ID: 703058
  • Duration: 90 Min
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.
CD/Recorded
$199
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Recorded/CD
Effective Deviation Investigators Under GMP

Effective Deviation Investigators Under GMP

  • Speaker: David L Chesney
  • Product ID: 704974
  • Duration: 120 Min
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.
CD/Recorded
$229
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Recorded/CD
Navigating the variations in state food regulatory structure

Navigating the variations in state food regulatory structure

  • Speaker: Darin Detwiler
  • Product ID: 705006
  • Duration: 90 Min
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.
CD/Recorded
$0
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Recorded/CD
Compliance with the New ICH GCP revised 2 Guidelines

Compliance with the New ICH GCP revised 2 Guidelines

  • Speaker: Laura Brown
  • Product ID: 704989
  • Duration: 60 Min
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.
CD/Recorded
$0
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Recorded/CD
The 21 Elements of a 510(k)

The 21 Elements of a 510(k)

  • Speaker: John E Lincoln
  • Product ID: 702323
  • Duration: 90 Min
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.
CD/Recorded
$279
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Recorded/CD
Detailing Transportation Fringe Benefits

Detailing Transportation Fringe Benefits

  • Speaker: Vicki M. Lambert
  • Product ID: 705003
  • Duration: 90 Min
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.
CD/Recorded
$299
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Recorded/CD
Using the ISP98 Model Forms for Standby Letters of Credit

Using the ISP98 Model Forms for Standby Letters of Credit

  • Speaker: Buddy Baker
  • Product ID: 702830
  • Duration: 90 Min
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.
CD/Recorded
$249
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Recorded/CD
The Essentials of Third Party Sick Pay: What Payroll Must know to Tax and Report Correctly

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

  • Speaker: Vicki M. Lambert
  • Product ID: 704992
  • Duration: 90 Min
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.
CD/Recorded
$299
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Recorded/CD
Data Analysis in QSR

Data Analysis in QSR

  • Speaker: Daniel O Leary
  • Product ID: 704990
  • Duration: 90 Min
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.
CD/Recorded
$0
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