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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
FDA Enforcement and Your Compliance Program

FDA Enforcement and Your Compliance Program

  • Speaker: Jason Mefford
  • Product ID: 702535
  • Duration: 60 Min
This webinar will review the new FDA requirements related to the Food Safety Modernization Act (FSMA), discuss recent enforcement actions by the FDA and show how you can modify your compliance programs to meet these new requirements.
CD/Recorded
$229
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Recorded/CD
Healthcare-associated Infections: An Overview of Regulatory Requirements Applicable to Hospitals and Other Healthcare Facilities

Healthcare-associated Infections: An Overview of Regulatory Requirements Applicable to Hospitals and Other Healthcare Facilities

  • Speaker: Julie Reagan
  • Product ID: 703002
  • Duration: 100 Min
This webinar will provide a comprehensive review of Federal Healthcare-associated Infections (HAI) initiatives and regulatory requirements along with a detailed discussion of federal CMS reporting requirements.
CD/Recorded
$229
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Recorded/CD
Essential Last Minute Preparation for an Imminent FDA Inspection

Essential Last Minute Preparation for an Imminent FDA Inspection

  • Speaker: Chris Cook
  • Product ID: 703004
  • Duration: 60 Min
This webinar on preparing for FDA inspections will present simple but powerful tools, with real world examples on how to prepare for an impending FDA inspection. You will learn what essential last minute preparation activities can be done and others that should be avoided.
CD/Recorded
$229
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Recorded/CD
Additional Medicare Reporting Under the Sunshine Act Rules of 2013

Additional Medicare Reporting Under the Sunshine Act Rules of 2013

  • Speaker: Mukesh Kumar
  • Product ID: 702998
  • Duration: 60 Min
This webinar will provide a summary of the additional medicare reporting requirements under the Sunshine Act rules, and tips for assuring compliance to protect both the manufacturers of FDA regulated products and physicians.
CD/Recorded
$229
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Recorded/CD
Dietary Supplements Ingredient and Labeling Compliance

Dietary Supplements Ingredient and Labeling Compliance

  • Speaker: Marc Sanchez
  • Product ID: 702997
  • Duration: 60 Min
This webinar on dietary supplements will cover product ingredient reviews and FDA requirements for labeling your products in the US. You will learn how to avoid claims, what claims are permissible and how to remedy challenged claims.
CD/Recorded
$229
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Recorded/CD
Tax Levies and Creditor Garnishments Maintaining Compliance and Eliminating Problems

Tax Levies and Creditor Garnishments Maintaining Compliance and Eliminating Problems

  • Speaker: Vicki M. Lambert
  • Product ID: 702948
  • Duration: 90 Min
This HR regulations training will clearly explain how to handle tax levies and creditor garnishments efficiently and in compliance with the Federal and state requirements.
CD/Recorded
$149
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Recorded/CD
Food Allergen Control for Food Industry Professionals

Food Allergen Control for Food Industry Professionals

  • Speaker: Melinda Allen
  • Product ID: 702976
  • Duration: 90 Min
This food safety training will provide a comprehensive understanding of food allergens and the risks involved. You will learn how to control or manage food allergens from development to labeling in a food manufacturing environment.
CD/Recorded
$229
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Recorded/CD
Foreign Corrupt Practices Act & UK Anti-Bribery

Foreign Corrupt Practices Act & UK Anti-Bribery

  • Speaker: Denise Cicchella
  • Product ID: 702956
  • Duration: 60 Min
This Foreign corrupt Practices Act (FCPA) compliance training will discuss common red flags for potential breaches of the Act and recent enforcement trends for noncompliance.
CD/Recorded
$149
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Recorded/CD
Analytical Test Methods Validation: FDA, ICH and USP Requirements

Analytical Test Methods Validation: FDA, ICH and USP Requirements

  • Speaker: Richard Poser(PhD)
  • Product ID: 701122
  • Duration: 90 Min
This method validation training will address the regulatory requirements which apply at the various stages of product development, and suggest proven strategies for compliant and phase-appropriate analytical method validation.
CD/Recorded
$159
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Recorded/CD
FDA and Social Media - How to Promote your Products Using Web 2.0 in Compliance with FDA and FTC Laws and Regulations

FDA and Social Media - How to Promote your Products Using Web 2.0 in Compliance with FDA and FTC Laws and Regulations

  • Speaker: Mark Gardner
  • Product ID: 702907
  • Duration: 90 Min
This webinar on FDA social media regulations will discuss the best practices utilized by medical device, drug and other FDA and FTC regulated industries when using social media channels, i.e., Web 2.0, like Facebook, Twitter, YouTube and LinkedIn to promote products.
CD/Recorded
$229
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Recorded/CD
Global Medical Device Laws and Regulations: US, EU, and Canada

Global Medical Device Laws and Regulations: US, EU, and Canada

  • Speaker: David Lim
  • Product ID: 702842
  • Duration: 90 Min
This training on global medical device regulations will discuss the regulatory framework for medical devices in US, EU and Canada. It will outline systematic methods to identify and meet regulatory requirements and streamline the regulatory process in these countries.
CD/Recorded
$50
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Recorded/CD
FDA's Revised 510(k) Process: The Medical Device Professional's Guide to Successfully Preparing 510(k) Submissions and Regulatory Compliance

FDA's Revised 510(k) Process: The Medical Device Professional's Guide to Successfully Preparing 510(k) Submissions and Regulatory Compliance

  • Speaker: Chris Cook
  • Product ID: 702963
  • Duration: 70 Min
This medical device 510(k) training will help you understand the basics of 510(k) submissions and discuss how to develop and execute an approval strategy ensuring the fastest possible path to market.
CD/Recorded
$229
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Recorded/CD
Understanding and Administrating COBRA: Avoiding Costly Conflicts with Government Agencies

Understanding and Administrating COBRA: Avoiding Costly Conflicts with Government Agencies

  • Speaker: Kenneth Sprang
  • Product ID: 702966
  • Duration: 60 Min
This COBRA (Consolidated Omnibus Budget Reconciliation Act) administration HR training course is designed to provide a comprehensive view of COBRA rule and it will also provide pragmatic tips on structuring and administering COBRA in your organization.
CD/Recorded
$50
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Recorded/CD
Medical Device Reporting for Manufacturers, Importers and Medical Device User Facilities

Medical Device Reporting for Manufacturers, Importers and Medical Device User Facilities

  • Speaker: Kosta Makrodimitris
  • Product ID: 702958
  • Duration: 90 Min
This webinar on Medical Device Reporting (MDR) will cover FDA requirements for importers, manufacturers and hospitals to report medical device adverse events. It will discuss current policies and guidances for Medical Device Reporting and provide update on upcoming regulations.
CD/Recorded
$149
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Recorded/CD
Auditing Systems for 21 CFR Part 11 Compliance: Preparing Yourself for Inspection

Auditing Systems for 21 CFR Part 11 Compliance: Preparing Yourself for Inspection

  • Speaker: Richard Poser(PhD)
  • Product ID: 700970
  • Duration: 90 Min
This 21 CFR Part 11 compliance training will present a methodology for system assessment, risk-analysis, 21CFR Part 11 compliance, remediation and inventory, along with templates and forms that attendees can modify for their own business.
CD/Recorded
$229
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Recorded/CD
New QC Based on Risk Management: A Collaboration between CLIA and CLSI

New QC Based on Risk Management: A Collaboration between CLIA and CLSI

  • Speaker: Pamela Tayon Colker
  • Product ID: 702385
  • Duration: 60 Min
This lab quality compliance training will provide a comprehensive overview of the Clinical and Laboratory Standards Institute (CLSI) Laboratory Quality Control Based on Risk Management; Approved Guideline, EP-23-A, produced in partnership with the Clinical Laboratory Improvement Amendment (CLIA).
CD/Recorded
$229
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Recorded/CD
The Sunshine Act Final Rule

The Sunshine Act Final Rule

  • Speaker: Mark Gardner
  • Product ID: 702825
  • Duration: 120 Min
This session will discuss in detail the Final Rule for the Physician Payment Sunshine Act, its impact and how to prepare for it. You will learn about reporting, certification and registration deadlines and what specifically needs to be reported or provided to CMS.
CD/Recorded
$249
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Recorded/CD
Telehealth/Telemedicine Regulations and Services in the USA

Telehealth/Telemedicine Regulations and Services in the USA

  • Speaker: Kosta Makrodimitris
  • Product ID: 702861
  • Duration: 90 Min
This healthcare compliance training will explain the current landscape of telehealth or telemedicine regulations in the US, reporting and documentation requirements, and the different telemedicine services and technologies.
CD/Recorded
$229
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Recorded/CD
Common Import Compliance Problems

Common Import Compliance Problems

  • Speaker: Michael Laden
  • Product ID: 702878
  • Duration: 90 Min
This customs and trade compliance training will review a number of common issues and problems related to compliance with U.S. import laws and strategies or solutions for mitigating those issues.
CD/Recorded
$50
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Recorded/CD
Creating a Quality Assurance Program for (Clinical) Research Sites

Creating a Quality Assurance Program for (Clinical) Research Sites

  • Speaker: Amanda Shepler
  • Product ID: 702855
  • Duration: 60 Min
This clinical research QA training will provide practical advice for clinical research sites on when and how to get started with building their quality assurance program. A table of contents of the most critical SOPs will be provided.
CD/Recorded
$149
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