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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
Russia: Compliance Processes and Regulations

Russia: Compliance Processes and Regulations

  • Speaker: Robert J Russell
  • Product ID: 703870
  • Duration: 90 Min
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.
CD/Recorded
$249
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Recorded/CD
Physician Compensation and Population Health: Strategies for Implementing Value-Based Models

Physician Compensation and Population Health: Strategies for Implementing Value-Based Models

  • Speaker: Joseph Wolfe
  • Product ID: 704562
  • Duration: 60 Min
This training program will provide a general overview of the Stark Law, the Anti-Kickback Statute and the Civil Monetary Penalties Law. It will also discuss requirements for compliance with key regulatory exceptions and safe harbors and best practices for implementing value-based physician compensation models.
CD/Recorded
$229
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Recorded/CD
Quality Assurance at the (Clinical Research) Site: How to Develop a Manageable Plan

Quality Assurance at the (Clinical Research) Site: How to Develop a Manageable Plan

  • Speaker: Jennifer Holcomb
  • Product ID: 702406
  • Duration: 60 Min
This clinical compliance training will help attendees understand how they can develop and implement a Quality Assurance (QA) program at their clinical research site that ensures the staff are properly trained and that the research is carried out in accordance with regulatory expectations.
CD/Recorded
$249
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Recorded/CD
What is Required for RoHS2 per EN 50581, 2012?

What is Required for RoHS2 per EN 50581, 2012?

  • Speaker: Jim Kandler
  • Product ID: 704988
  • Duration: 60 Min
This training program will discuss the manufacturer’s obligations mentioned in the EN 50581, 2012 guidance document. The topics in the guidance document will be explored from the perspective of a US manufacturer.
CD/Recorded
$0
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Recorded/CD
Creating a Good Design History File (DHF) for Audit Success

Creating a Good Design History File (DHF) for Audit Success

  • Speaker: Mercedes Massana
  • Product ID: 701978
  • Duration: 60 Min
This DHF regulatory compliance training will discuss the structure of a good Design History File, elements to look for when auditing a DHF and how to address issues. It will provide the information necessary to maintain a good DHF that will help manufacturers during a regulatory compliance audit.
CD/Recorded
$279
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Recorded/CD
Equipment Qualification Basics

Equipment Qualification Basics

  • Speaker: Joy McElroy
  • Product ID: 704403
  • Duration: 90 Min
This training program will list the documents required for equipment qualification and process validation and discuss how to manage documents appropriately. Attendees will gain insight into best practices for writing and maintaining a Validation Master Plan (VMP). The course will also discuss best practices for writing and executing sound protocols for equipment qualification (IQ, OQ, PQ) and process validation.
CD/Recorded
$159
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Recorded/CD
Retaliation and Whistleblower Claims | No FEAR Act, Trends and Best Practices to Avoid Litigation

Retaliation and Whistleblower Claims | No FEAR Act, Trends and Best Practices to Avoid Litigation

  • Speaker: Susan Fahey Desmond
  • Product ID: 704903
  • Duration: 90 Min
This webinar training will discuss about the whistleblower claims and NO FEAR Act. The Instructor will discuss the types of whistleblower claims and new developments under the No FEAR Act. Participants will learn how to manage internal investigation and litigation issues.
CD/Recorded
$229
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Recorded/CD
You Found an Objectionable Microorganism, Now What? Risk of presence of Objectionable Microorganisms in Biopharmaceuticals

You Found an Objectionable Microorganism, Now What? Risk of presence of Objectionable Microorganisms in Biopharmaceuticals

  • Speaker: Henry Urbach
  • Product ID: 702964
  • Duration: 60 Min
This webinar on objectionable microorganisms will explore the most current practices that define an objectionable microorganism and will provide a practical approach to determining just how objectionable it really is.
CD/Recorded
$229
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Recorded/CD
OSHA Enforcement for Employers Using Temporary Workers

OSHA Enforcement for Employers Using Temporary Workers

  • Speaker: Michael Aust
  • Product ID: 704972
  • Duration: 60 Min
This training program will address OSHA’s initiative focusing on safety and health compliance for temporary workers. It will detail OSHA’s TWI initiative for temporary workers and review OSHA’s Bulletins 1-7.
CD/Recorded
$0
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Recorded/CD
How to Pay Overtime Correctly under the Fair Labor Standards Act - Legal risk and court interpretations

How to Pay Overtime Correctly under the Fair Labor Standards Act - Legal risk and court interpretations

  • Speaker: Susan Fahey Desmond
  • Product ID: 701874
  • Duration: 90 Min
This webinar on employee overtime calculation will help you understand what is “time worked”, exempt versus non-exempt status and how to calculate your employees' overtime correctly so to avoid these costly suits.
CD/Recorded
$229
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Recorded/CD
Structuring Physician Recruitment and Non-Physician Practitioner Support Arrangements Under the New 2016 Stark Rules

Structuring Physician Recruitment and Non-Physician Practitioner Support Arrangements Under the New 2016 Stark Rules

  • Speaker: Joseph Wolfe
  • Product ID: 704469
  • Duration: 60 Min
In this session, the training instructor will provide a general Stark Law overview. He will also discuss best practices for auditing existing recruitment arrangements and for implementing new NPP support arrangements under the new 2016 Stark rules.
CD/Recorded
$229
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Recorded/CD
Working With ELLA (Employment-Labor Law Audit): An HR Audit Model

Working With ELLA (Employment-Labor Law Audit): An HR Audit Model

  • Speaker: Ronald Adler
  • Product ID: 704968
  • Duration: 90 Min
This training program will discuss the use of Employment Labor Law Audit (ELLA®) as a core competency, review the role HR auditing plays in helping your organization make critical business decisions, and describe how ELLA® can help reduce employment practices liability risk exposure.
CD/Recorded
$229
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Recorded/CD
A Primer on OFAC/Sanctions Compliance

A Primer on OFAC/Sanctions Compliance

  • Speaker: Joe Soniat
  • Product ID: 704998
  • Duration: 60 Min
This training program will detail the purpose of OFAC screening and OFAC risk assessment. It will define a politically exposed person (PEP). Further, the webinar will also offer best practices regarding the OFAC screening process and guide attendees on how to document the process of an OFAC case review.
CD/Recorded
$599
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Recorded/CD
Employer's Continuing Obligation: Maintaining Accurate Records of Each Recordable Injury and Illness

Employer's Continuing Obligation: Maintaining Accurate Records of Each Recordable Injury and Illness

  • Speaker: Michael Aust
  • Product ID: 704982
  • Duration: 60 Min
This OSHA training program will discuss updated recordkeeping mandates set by OSHA and emphasize the importance of OSHA's recordkeeping regulations. The webinar will further detail why a failure to record a recordable illness or injury is a continuing violation and the D.C. circuit's decision in Volks II.
CD/Recorded
$0
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Recorded/CD
Developing an Affirmative Action Plan in the Age of Inclusion-Title VII of Civil Rights ACT 1964

Developing an Affirmative Action Plan in the Age of Inclusion-Title VII of Civil Rights ACT 1964

  • Speaker: U Harold Levy
  • Product ID: 704925
  • Duration: 90 Min
This webinar discusses how and why the demographics of country are changing and the business impact of an inclusive business environment. The instructor will explain the federal and state laws and policy that provide for equal employment opportunity and affirmative action in employment. Participants will learn how to develop a fair and equitable Affirmative Action Plan that can withstand scrutiny.
CD/Recorded
$0
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Recorded/CD
Selection and Management of Contract Vendors

Selection and Management of Contract Vendors

  • Speaker: Peggy Berry
  • Product ID: 704884
  • Duration: 90 Min
This webinar will discuss approaches to selecting vendors to perform manufacturing and testing activities as well as clinical study activities. The information obtained will enable implementation of an effective vendor selection program and a comprehensive vendor management and oversight program. The webinar will address aspects of requesting bids, performing audits, evaluating risks, and preparing plans and agreements for effective oversight and management.
CD/Recorded
$0
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Recorded/CD
The Investigational Medicinal Product Dossier (IMPD): EU's CTA vs. FDA's IND

The Investigational Medicinal Product Dossier (IMPD): EU's CTA vs. FDA's IND

  • Speaker: Robert J Russell
  • Product ID: 702030
  • Duration: 90 Min
This 90 minute webinar will help you comprehensively understand the IMPD (Investigational Medicinal Product Dossier) and the structure and content differences between a EU CTA Application and an FDA IND Application.
CD/Recorded
$249
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Recorded/CD
Export Control Awareness: Apply and Understand Licensing Exceptions

Export Control Awareness: Apply and Understand Licensing Exceptions

  • Speaker: Matilda Vasquez
  • Product ID: 704963
  • Duration: 60 Min
This training program will review changes in the Foreign Trade Regulations, Export Administration Regulations, Office of Foreign Assets Controls, and the International Traffic in Arms Regulations. It will also offer an understanding of the basics of applying for an export license through the BIS.
CD/Recorded
$0
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Recorded/CD
Preparing a Financial Industry Compliance Manual and Code of Ethics

Preparing a Financial Industry Compliance Manual and Code of Ethics

  • Speaker: Lisa Marsden
  • Product ID: 704962
  • Duration: 60 Min
This training program will detail developing a compliance manual and a code of ethics for the financial industry, with the intent of clarifying the requirements of the Advisers Act. The instructor will also guide attendees on testing the manual, effectively managing it, and keeping it constantly updated.
CD/Recorded
$0
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Recorded/CD
Mission to Mitigate: Preventing recalls and outbreaks by design

Mission to Mitigate: Preventing recalls and outbreaks by design

  • Speaker: Darin Detwiler
  • Product ID: 704966
  • Duration: 90 Min
This course is designed to bring food industry leaders up to speed with the latest in related policy characteristics. The goal is to enable industry leaders to better understand the food policy landscape.
CD/Recorded
$0
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