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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
Conducting a Risk Analysis to Comply with Meaningful Use, HIPAA and HITECH

Conducting a Risk Analysis to Comply with Meaningful Use, HIPAA and HITECH

  • Speaker: William Miaoulis
  • Product ID: 703347
  • Duration: 90 Min
This webinar will discuss how to do a security risk analysis to meet the requirements of HIPAA, HITECH and Meaningful Use attestation. It will describe ways for effectively completing a risk analysis at the organizational level, the network level and the application level.
CD/Recorded
$229
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Recorded/CD
Major Changes to the EU Clinical Trials Regulation: What is Required for Compliance

Major Changes to the EU Clinical Trials Regulation: What is Required for Compliance

  • Speaker: Laura Brown
  • Product ID: 703336
  • Duration: 60 Min
This webinar will help Sponsors, CROs and study sites running clinical trials in the EU and internationally; understand the important, updated compliance requirements concerning the new EU Clinical Trials Regulation due to be enacted in 2016 and which will replace the 2001 Clinical Trials Directive (CTD) (2001/20/EC).
CD/Recorded
$229
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Recorded/CD
Optimize Your Import Contracts for Compliance and Risk Management

Optimize Your Import Contracts for Compliance and Risk Management

  • Speaker: Scott Lowden
  • Product ID: 703326
  • Duration: 60 Min
This webinar will provide tools and tips for optimizing imports contracts to ensure compliance and reduce risk. Attendees will be able to review their contracting practices, PO forms and purchasing procedures to make the best use of their advantages as a buyer.
CD/Recorded
$50
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Recorded/CD
Regulatory Documentation for Clinical Trials

Regulatory Documentation for Clinical Trials

  • Speaker: Adam Ruskin
  • Product ID: 703329
  • Duration: 60 Min
This clinical research compliance training will explain in detail the list of required regulatory documentation for clinical trials for industries such as pharmaceutical, biotechnology, medical devices and diagnostics. It will also review many of the documents in terms of required content and structure.
CD/Recorded
$229
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Recorded/CD
Anti-Corruption Program including the Foreign Corrupt Practices Act (FCPA)

Anti-Corruption Program including the Foreign Corrupt Practices Act (FCPA)

  • Speaker: Robert Brewer
  • Product ID: 703316
  • Duration: 75 Min
This webinar will explain the anti-bribery and accounting provisions of the Foreign Corrupt Practices Act (FCPA) and will also discuss the UK Bribery Act. Learn the best practices for avoiding penalties for FCPA, UK Bribery Act, or local law violations.
CD/Recorded
$149
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Recorded/CD
All about NAFTA and its Impact if You Have to Abide by It

All about NAFTA and its Impact if You Have to Abide by It

  • Speaker: David Ross
  • Product ID: 703348
  • Duration: 60 Min
The webinar will provide detailed information on how to comply with NAFTA basics such as Harmonized Tariff classification, valuation, Country of Origin determination and marking requirements. Attendees will also learn how to comply with NAFTA’s often complex rules for eligibility thus mitigating the risk of violations that are subject to stiff fines and penalties from US, Canadian and Mexican Customs authorities.
CD/Recorded
$149
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Recorded/CD
Independent Contractor or Employee - Guidelines to Insure Compliance

Independent Contractor or Employee - Guidelines to Insure Compliance

  • Speaker: Kenneth Sprang
  • Product ID: 703227
  • Duration: 60 Min
This webinar will discuss the criteria used by the DOL, the EEOC and the IRS to distinguish between contractors and employees and how you can avoid mis-classifying employees as independent contractors.
CD/Recorded
$149
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Recorded/CD
Valuation: How to Determine Customs Value

Valuation: How to Determine Customs Value

  • Speaker: Reynaldo Roman
  • Product ID: 703304
  • Duration: 60 Min
This webinar will explain the WTO Agreement on Customs value and valuation methods. Attendees will learn how to use the valuation methods to determine Customs value.
CD/Recorded
$149
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Recorded/CD
Risk Areas Planned for Review and Regulatory Changes - New Challenges With Respect to Government Audits and Investigations in Health Care

Risk Areas Planned for Review and Regulatory Changes - New Challenges With Respect to Government Audits and Investigations in Health Care

  • Speaker: Susan Lee Walberg
  • Product ID: 703322
  • Duration: 60 Min
This webinar will focus on the current healthcare fraud and abuse enforcement environment and the specific emerging risk areas and strategies for dealing with those. Attendees will learn how to best use their existing resources and data to stay ahead of these government audits and investigations.
CD/Recorded
$229
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Recorded/CD
Updating HIPAA Compliance in Medical Offices

Updating HIPAA Compliance in Medical Offices

  • Speaker: Jim Sheldon-Dean
  • Product ID: 703330
  • Duration: 90 Min
This HIPAA compliance training will focus on the privacy policies and Notices of Privacy Practices that must be updated to ensure compliance with the final HIPAA Omnibus rule. Attendees will learn best practices to avoid breaches and penalties for non-compliance.
CD/Recorded
$149
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Recorded/CD
Managing Export Authorizations during the ECR Transition Period: How to Maximize Efficiency While Minimizing Risk

Managing Export Authorizations during the ECR Transition Period: How to Maximize Efficiency While Minimizing Risk

  • Speaker: Darrell Coleman
  • Product ID: 703311
  • Duration: 60 Min
This webinar will explain how to manage export authorizations during the transition of products to the Export Administration Regulations (EAR). It will discuss advantages and disadvantages associated with transitioning products as well as the various exceptions available including the STA exception for the new 600 Series products.
CD/Recorded
$149
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Recorded/CD
Why Social Networking Is a Concern for Human Resource Professional: Complying with Employment and Labor Laws

Why Social Networking Is a Concern for Human Resource Professional: Complying with Employment and Labor Laws

  • Speaker: Susan Fahey Desmond
  • Product ID: 701872
  • Duration: 90 Min
Understand why social networking sites use by employees is a concern, the potential legal risks associated with use of social networking sites for recruiting process, and how your failure to handle a social networking problem can lead to other legal problems.
CD/Recorded
$149
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Recorded/CD
Essential Do's and Don'ts for Navigating a Successful 505(b)(2) Drug Application

Essential Do's and Don'ts for Navigating a Successful 505(b)(2) Drug Application

  • Speaker: Thomas Reilly
  • Product ID: 703314
  • Duration: 60 Min
This FDA New Drug Approval process training will provide attendees with the knowledge and skills needed to develop a successful 505 (b)(2) program.
CD/Recorded
$229
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Recorded/CD
Understanding and Interpreting the EMA Reflection Paper on GCP Compliance in Relation to Trial Master Files (paper and/or electronic) for Management, Audit and Inspection of Clinical Trials

Understanding and Interpreting the EMA Reflection Paper on GCP Compliance in Relation to Trial Master Files (paper and/or electronic) for Management, Audit and Inspection of Clinical Trials

  • Speaker: Eldin Rammell
  • Product ID: 703281
  • Duration: 60 Min
This training will give attendees an insight into the interpretation of GCP regulations by the European Medicines Agency (EMA) as they relate to the management of trial documents, focusing especially on clarification within the paper on disputed and ambiguous areas of trial master file (TMF) management.
CD/Recorded
$229
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Recorded/CD
7 Pillars of an Effective Compliance Program for Healthcare Companies: Lessons Learned from a Prosecutor's Perspective

7 Pillars of an Effective Compliance Program for Healthcare Companies: Lessons Learned from a Prosecutor's Perspective

  • Speaker: Alice H Martin,Michael Rosen
  • Product ID: 703280
  • Duration: 60 Min
This healthcare best practices training will discuss the seven recognized pillars that a compliance plan should include and the details that will allow attendees to reduce their company’s potential liability under the Federal U.S. Sentencing Guidelines. Learn from examples of healthcare companies that did not have or follow an effective compliance plan and the resulting civil fines and penalties as well as government oversight and audits that ensued.
CD/Recorded
$229
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Recorded/CD
3 Ways to Avoid Costly Wage and Hour Problems

3 Ways to Avoid Costly Wage and Hour Problems

  • Speaker: Michael Haberman
  • Product ID: 703293
  • Duration: 60 Min
This Fair Labor Standards Act compliance training will focus on the ways to avoid costly wage and hour problems under FLSA. Attendees will learn exempt classification and how to calculate overtime.
CD/Recorded
$50
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Recorded/CD
Illegal Harassment v/s Legal Workplace Bullying

Illegal Harassment v/s Legal Workplace Bullying

  • Speaker: Catherine Mattice Zundel
  • Product ID: 703291
  • Duration: 60 Min
This training will help you understand the concept of workplace bullying. You will understand the similarities and differences between illegal harassment with legal workplace bullying & how to handle them. Attendees will learn tools for managing bullying at work.
CD/Recorded
$149
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Recorded/CD
Performing an OIG (Office of Inspector General) Excluded Provider Audit

Performing an OIG (Office of Inspector General) Excluded Provider Audit

  • Speaker: Kevin McPoyle
  • Product ID: 703276
  • Duration: 90 Min
This training on healthcare compliance will teach the attendees best practices for conducting a self audit of excluded providers. Learn how to prepare and conduct an audit to ensure compliance with this important mandate of Medicare participation.
CD/Recorded
$229
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Recorded/CD
3-hr Virtual Seminar: FDA's Establishment Registration and Product Listing Requirements, User Fees, Fee Waivers and Market Exclusivity

3-hr Virtual Seminar: FDA's Establishment Registration and Product Listing Requirements, User Fees, Fee Waivers and Market Exclusivity

  • Speaker: Karl M. Nobert
  • Product ID: 703269
  • Duration: 3 hrs
This 3-hour training will review and compare FDA’s Establishment Registration and Product Listing Requirements; and available User Fees, Fee Waivers and Marketing Exclusivity for Drugs, Biologics, Medical Devices, Food, Tobacco and Animal Health Products.
CD/Recorded
$499
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Recorded/CD
Managing Products in California: Compliance with Prop 65, Green Chemistry and the Rigid Plastic Packaging Act

Managing Products in California: Compliance with Prop 65, Green Chemistry and the Rigid Plastic Packaging Act

  • Speaker: Lee N Smith
  • Product ID: 703266
  • Duration: 60 Min
This webinar will provide an in-depth understanding of California specific laws, affecting food and other product manufacturers and marketers, such as the Prop 65, the Green Chemistry Initiative, and the Rigid Plastic Packaging Act. We will discuss these laws, how to comply with them and avoid litigation.
CD/Recorded
$229
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