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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
Asian Medical Device Laws and Regulations: China, Hong Kong, Japan and Korea

Asian Medical Device Laws and Regulations: China, Hong Kong, Japan and Korea

  • Speaker: David Lim
  • Product ID: 702841
  • Duration: 90 Min
This training on Asian medical device regulations will discuss the regulatory framework for medical devices in China, Hong Kong, Japan and Korea. It will outline systematic methods to identify and meet regulatory requirements and streamline the regulatory process in these Asian countries.
CD/Recorded
$229
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Recorded/CD
Country of Origin Marking for U.S. Imports

Country of Origin Marking for U.S. Imports

  • Speaker: Michael Laden
  • Product ID: 702849
  • Duration: 60 Min
This Country of Origin Marking for US Imports webinar will cover the requirements for marking imported goods and materials with the country of origin and conforming with U.S. Customs & Border Protection (CBP) rules.
CD/Recorded
$149
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Recorded/CD
Current Trends in Reporting Surgical Assistants

Current Trends in Reporting Surgical Assistants

  • Speaker: Lynn M Anderanin
  • Product ID: 702824
  • Duration: 60 Min
This session on reporting surgical assistants will review the means of determining when a surgical assistant is appropriate based on the guidelines published by CMS, and the affects or reimbursement for non physician providers.
CD/Recorded
$229
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Recorded/CD
What you Need to Know to Successfully Market and Sell an Over-the-Counter Drug Product in the United States; and Strategic Advice for Avoiding FDA Enforcement Action

What you Need to Know to Successfully Market and Sell an Over-the-Counter Drug Product in the United States; and Strategic Advice for Avoiding FDA Enforcement Action

  • Speaker: Karl M. Nobert
  • Product ID: 702840
  • Duration: 120 Min
This training on OTC drug marketing is intended to be a practice-based online workshop that will explain what you need to know to successfully market and sell an Over-the-Counter drug product in the United States; and provide strategic advice for avoiding FDA enforcement action.
CD/Recorded
$349
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Recorded/CD
Conventional Food Claims and Labeling

Conventional Food Claims and Labeling

  • Speaker: Bradley Johnson
  • Product ID: 702695
  • Duration: 90 Min
This webinar will cover how conventional food companies should label their products for the US market per FDA requirements, considerations avoid claims, building regulatory compliance into company programs for development and launch of properly labeled dietary supplements.
CD/Recorded
$229
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Recorded/CD
Dietary Supplements Labeling - Avoiding Claims that Invite Scrutiny and Penalties

Dietary Supplements Labeling - Avoiding Claims that Invite Scrutiny and Penalties

  • Speaker: Marc Sanchez
  • Product ID: 702807
  • Duration: 60 Min
This training will cover FDA requirements for labeling dietary supplements. It will show how you can avoid dietary supplement labeling claims by properly labeling your products for the US market per FDA requirements.
CD/Recorded
$229
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Recorded/CD
How to Make GMP Training Fun and Engaging

How to Make GMP Training Fun and Engaging

  • Speaker: Grimoalda Botelho
  • Product ID: 702808
  • Duration: 60 Min
This session on conducting effective GMP trainings will cover proven learning techniques for technical and compliance related trainings. It will answer key questions about how to make GMP training sessions more engaging and even fun for the learners in your organization.
CD/Recorded
$50
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Recorded/CD
Preparing for a Centers for Medicare and Medicaid Services (CMS) Audit: What Not To Do

Preparing for a Centers for Medicare and Medicaid Services (CMS) Audit: What Not To Do

  • Speaker: Mark Sexton
  • Product ID: 702811
  • Duration: 60 Min
This CMS audit training will address the types of information CMS is seeking, the documentation that you need to have to demonstrate not only compliance, but good faith as well.
CD/Recorded
$229
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Recorded/CD
3-hr Virtual Seminar: Annual ICH GCP Refresher Course

3-hr Virtual Seminar: Annual ICH GCP Refresher Course

  • Speaker: Christine Hegi
  • Product ID: 702652
  • Duration: 3 hrs
This 3-hr virtual seminar will offer a comprehensive ICH GCP training for all healthcare professionals involved in clinical research.
CD/Recorded
$399
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Recorded/CD
Dietary Supplement Adverse Event Reporting and Recordkeeping Requirements under the Dietary Supplement and Nonprescription Drug Consumer Protection Act

Dietary Supplement Adverse Event Reporting and Recordkeeping Requirements under the Dietary Supplement and Nonprescription Drug Consumer Protection Act

  • Speaker: Katherine Giannamore
  • Product ID: 702756
  • Duration: 60 Min
This webinar on dietary supplement adverse event reporting will explain the requirements under federal law as to when serious adverse event reports must be submitted to the FDA, what information and when it must be submitted. In addition, it will highlight the recordkeeping requirements under the law pertaining to all adverse event reports.
CD/Recorded
$229
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Recorded/CD
Emergency Response Preparedness: Creating a Plan That Works

Emergency Response Preparedness: Creating a Plan That Works

  • Speaker: Michael Lawrence
  • Product ID: 702521
  • Duration: 60 Min
A well-done emergency plan ensures you are prepared – it saves lives, property, money, and ultimately, your reputation as an employer and a viable company! The objective of this 60 minute webinar is to clarify the information on emergency management planning and associated details at workplace. Also, the session will also help you develop a simple, easy, and effective Emergency Management Plan.
CD/Recorded
$149
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Recorded/CD
Food Marketing Claims in the United States: Regulatory and Litigation Risks, Defenses and Best Practices

Food Marketing Claims in the United States: Regulatory and Litigation Risks, Defenses and Best Practices

  • Speaker: Leslie T Krasny
  • Product ID: 702393
  • Duration: 75 Min
This training covers challenges to food marketing claims in FDA and FTC enforcement actions, consumer class action lawsuits, and proceedings brought by the National Advertising Division of the Council of Better Business Bureaus (NAD). It will discuss how to assess risk when considering claims, strategies for defending actions, and marketing trends in the food industry.
CD/Recorded
$229
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Recorded/CD
Political Contributions and Prohibitions on the Municipal Securities Business

Political Contributions and Prohibitions on the Municipal Securities Business

  • Speaker: Kimberly McManus
  • Product ID: 702798
  • Duration: 60 Min
This municipal securities compliance training will clearly explain the MSRB (Municipal Securities Rulemaking Board) Rule-37, discuss the key elements of political contribution restrictions and prohibitions on the municipal securities business, disclosure requirements, violations and how to prevent them.
CD/Recorded
$149
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Recorded/CD
HIPAA Risk Analysis: The HIPAA Standard, HIPAA Security rule

HIPAA Risk Analysis: The HIPAA Standard, HIPAA Security rule

  • Speaker: Coy Murchison
  • Product ID: 702605
  • Duration: 60 Min
This HIPAA risk analysis webinar will help you to understand the components needed to conduct a comprehensive security, risk analysis for your organization, in order to comply with the HIPAA standards and the far reaching affects of the HITECH Act. You will learn how to identify sources of PHI and ePHI in your organization, external sources and the threats to information system that contain PHI and ePHI.
CD/Recorded
$149
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Recorded/CD
3-hr Virtual Seminar - The Interface Between Medicare and Medicaid, Anti-kickback Statute (AKS), Stark II and the Federal Civil False Claims Act (FCA): Is your Organization at Risk?

3-hr Virtual Seminar - The Interface Between Medicare and Medicaid, Anti-kickback Statute (AKS), Stark II and the Federal Civil False Claims Act (FCA): Is your Organization at Risk?

  • Speaker: William Mack Copeland
  • Product ID: 702787
  • Duration: 3 hrs
This healthcare compliance training will explain how the FCA, the AKS and the Federal Physician Self Referral Law (Stark II) work, the prohibitions, exceptions and safe harbors. It will review recent examples to show how they interface and can potentially impact you/ your organization.
CD/Recorded
$399
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Recorded/CD
Dispelling the Myths About Clinical Standardization

Dispelling the Myths About Clinical Standardization

  • Speaker: Kit Howard
  • Product ID: 702494
  • Duration: 90 Min
This 90-minute webinar will examine the many myths that get in the way of clinical standards adoption and demonstrate how complying with required standards benefits both the FDA and sponsors.
CD/Recorded
$229
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Recorded/CD
NAFTA Qualification Process for USA, Mexico and Canada

NAFTA Qualification Process for USA, Mexico and Canada

  • Speaker: Raul Campos
  • Product ID: 702714
  • Duration: 60 Min
This 60 minute online training will focus on how to apply rules of origin and different processes when qualifying products under NAFTA (North American Free Trade Agreement).
CD/Recorded
$149
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Recorded/CD
High Voltage for Qualified Person

High Voltage for Qualified Person

  • Speaker: Leo Muckerheide
  • Product ID: 702474
  • Duration: 90 Min
This webinar will help you understand OSHA’s Electric Power Generation, Transmission, & Distribution Standard and the applicable changes contained in the 2012 Edition of the National Electric Safety Code (NESC).
CD/Recorded
$149
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Recorded/CD
Worker Safety - How to Reduce Accidents and Injuries Caused by Human Error

Worker Safety - How to Reduce Accidents and Injuries Caused by Human Error

  • Speaker: Edward R Bulakites
  • Product ID: 702631
  • Duration: 60 Min
This webinar on worker safety will explore the causes of human errors that lead to accidents and how to minimize those errors.
CD/Recorded
$149
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Recorded/CD
Electronic Records & Electronic Signatures; 21 CFR Part 11

Electronic Records & Electronic Signatures; 21 CFR Part 11

  • Speaker: Harry Huss
  • Product ID: 702491
  • Duration: 90 Min
This training on FDA compliant electronic records and signatures will will provide an overview and historical perspective of the Part 11 regulation, the general Part 11 requirements, electronic records requirements, and electronic signatures requirements.
CD/Recorded
$229
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