ComplianceOnline

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!

Recorded/CD
Appraising Credibility, Reaching Conclusions and Writing an Investigative Report:  A Critical Step to Minimize Liability

Appraising Credibility, Reaching Conclusions and Writing an Investigative Report: A Critical Step to Minimize Liability

  • Speaker: Dr. Susan Strauss
  • Product ID: 704444
  • Duration: 60 Min
This training program will explore best practices for conducting an investigation. It will explore in detail the requirement of a formal written report following the investigation. Writing the investigative report actually begins from the very beginning of your investigation and continues throughout the process.
CD/Recorded
$149
Recorded/CD
Fighting Healthcare Fraud and Abuse: The Stakes and Consequences

Fighting Healthcare Fraud and Abuse: The Stakes and Consequences

  • Speaker: Michael Reynolds
  • Product ID: 703383
  • Duration: 90 Min
This webinar will explain the laws that regulate Fraud, Waste, and Abuse (FWA) including the Stark law. Attendees will learn how to detect, prevent and report healthcare fraud and abuse.
CD/Recorded
$149
Recorded/CD
Current Legal and Regulatory Challenges for HR Professionals

Current Legal and Regulatory Challenges for HR Professionals

  • Speaker: Cathleen M. Hampton
  • Product ID: 704438
  • Duration: 90 Min
Are you at risk for non-compliance? Is your company a lawsuit waiting to happen? This training program will focus on how much of what HR professionals do involves legal compliance, litigation avoidance and ensuring that employee rights are not violated. Yet, employment laws and regulations are not only confusing, they’re constantly changing. Still, ignorance is not a defense and it is important for everyone involved to have an understanding of these issues.
CD/Recorded
$149
Recorded/CD
FDA Inspection Preparedness

FDA Inspection Preparedness

  • Speaker: Susan Muhr Leister
  • Product ID: 704221
  • Duration: 60 Min
This training program will discuss key terms and responsibilities related to FDA inspections and the purpose of the BIMO inspection program. It will also review the general purpose and overall process of an FDA inspection and enhance your inspection preparation strategies.
CD/Recorded
$229
Recorded/CD
The HIPAA Audit Program for 2016 - New Focus, New Process

The HIPAA Audit Program for 2016 - New Focus, New Process

  • Speaker: Jim Sheldon-Dean
  • Product ID: 704434
  • Duration: 150 Min
This training program will discuss the HIPAA audit program and how it works, and discuss the areas that caused the most issues in the 2012 audits. It will explore issues and entities that presented the most challenges, and highlight where entities need to improve their compliance the most, and also explore the typical risk issues that lead to breaches of health information and see how those issues may be a target for auditors in 2016.
CD/Recorded
$429
Recorded/CD
4 P’s of ITAR - Policies, Provisions, Procedures & Penalties

4 P’s of ITAR - Policies, Provisions, Procedures & Penalties

  • Speaker: Suzanne Richer
  • Product ID: 704343
  • Duration: 60 Min
This training program will offer an overview of the International Traffic in Arms Regulations (ITAR) Part 126 – General Policies and Provisions, Part 128 – Administrative Procedures.
CD/Recorded
$149
Recorded/CD
Complimentary Webinar - Best Practices for Teaching Technical Subjects

Complimentary Webinar - Best Practices for Teaching Technical Subjects

  • Speaker: David A Casavant
  • Product ID: 704427
  • Duration:
This 90 minute webinar is designed for presenters, new trainers, seasoned veterans or anyone responsible for presentations. The speaker will share cutting edge ideas on how to make a presentation that will easily explain difficult concepts and get the right message across to your audience.
CD/Recorded
$0
Recorded/CD
NAFTA Qualification Process for USA, Mexico and Canada

NAFTA Qualification Process for USA, Mexico and Canada

  • Speaker: Randi Waltuck Barnett
  • Product ID: 704424
  • Duration: 90 Min
This webinar explains the US Customs Modernization Act (the Mod Act) and NAFTA. Participants will understand the regulations and guidelines of NAFTA for Imports, including auditing Certificates of Origin for facial validity, NAFTA for Exports, including Tariff Shift & Regional Value Content ,NAFTA Record Keeping & Risks & Penalties.
CD/Recorded
$149
Recorded/CD
FDA’s New Endotoxin Test Guidance for Human Parenteral Drugs, Biological Products and Medical Devices

FDA’s New Endotoxin Test Guidance for Human Parenteral Drugs, Biological Products and Medical Devices

  • Speaker: Angela Dunston
  • Product ID: 704431
  • Duration: 90 Min
This training program will provide a review of the current testing requirements and discuss what happened to the old 87/91 LAL Guidance for Industry proposed guidance. The program will also discuss how to transition from one bacterial endotoxin test to another—understanding the RPT (Rabbit Pyrogen Test). Participants will also gain a clearer perspective of the Monocyte Activation Test (MAT).
CD/Recorded
$229
Recorded/CD
5-Hour Virtual Seminar: P2P Standards of Internal Controls -  Preapproved by the American Purchasing Society

5-Hour Virtual Seminar: P2P Standards of Internal Controls - Preapproved by the American Purchasing Society

  • Speaker: Chris Doxey
  • Product ID: 704195
  • Duration: 5 hrs
This two-part five-hour certificate program focuses on internal controls leading practices and standards for the Procure to Pay (P2P) process. Attendees will learn about internal controls best practices by focusing on the Internal Controls Questionnaires (ICQ) for each component of the P2P process. Participants in this program will obtain a certificate in Procure to Pay (P2P) Standards of Internal Controls from the American Purchasing Society (APS).
CD/Recorded
$499
Recorded/CD
New Part 11 Guidance for Clinical Trials: What This Means for You

New Part 11 Guidance for Clinical Trials: What This Means for You

  • Speaker: Sarah Fowler Dixon
  • Product ID: 702990
  • Duration: 60 Min
This training on 21 CFR Part 11 guidance for clinical trials will explain the new 21 CFR Part 11 regulations for electronic records and what that means for your organization and the clincial studies you conduct.
CD/Recorded
$229
Recorded/CD
Customer Service Begins in HR

Customer Service Begins in HR

  • Speaker: Mary Gormandy White
  • Product ID: 704411
  • Duration: 60 Min
This training program, participants will learn how and why customer service really begins with the HR function, and gain actionable knowledge that they can use to improve their ability to provide effective customer service to their organization’s very important internal customers. Speaker will discuss how we can set the right work culture and ethics through internal training of new and existing employee to deliver highest quality of customer service.
CD/Recorded
$50
Recorded/CD
HR Analytics: Forecasting and Planning Your HRM Better

HR Analytics: Forecasting and Planning Your HRM Better

  • Speaker: Tom Palladino
  • Product ID: 704265
  • Duration: 120 Min
This training program will discuss the difference between analytics and metrics, how analytics can be used to significantly help the business, case studies to demonstrate real life projects, how to develop an analytics model, and more.
CD/Recorded
$25
Recorded/CD
Developing and Implementing an Export Management Control Program

Developing and Implementing an Export Management Control Program

  • Speaker: Randi Waltuck Barnett
  • Product ID: 704400
  • Duration: 60 Min
This training program will offer attendees an understanding of the legal framework for US commercial exports and discuss how you can leverage your existing quality system (QS) for your exports. Participants will also learn to identify areas where their existing ERP can support ECMP requirements.
CD/Recorded
$50
Recorded/CD
I-9 Form Immigration Compliance - Is Your Company Ready for ICE?

I-9 Form Immigration Compliance - Is Your Company Ready for ICE?

  • Speaker: Bruce Buchanan
  • Product ID: 703930
  • Duration: 60 Min
This training program on I-9 form immigration compliance will discuss an organization’s preparedness for ICE inspections. It will detail compliance requirements and penalties for non-compliance along with course of action on receipt of Notice of Inspection from ICE.
CD/Recorded
$149
Recorded/CD
3-Hour Virtual Training: Guidelines for Performing a Corporate Wide Internal Audit Risk Assessment

3-Hour Virtual Training: Guidelines for Performing a Corporate Wide Internal Audit Risk Assessment

  • Speaker: Marna Steuart
  • Product ID: 704386
  • Duration: 180 Min
This training program will detail key components of a risk assessment and management program, and include a fraud risk assessment discussion. Other training points in the program include analyzing the methodology for successful risk assessment process, understanding the steps involved in the risk assessment process, and fraud risk assessment.
CD/Recorded
$199
Recorded/CD
HIPAA Enforcement Examples - Where Others Have Gone Wrong

HIPAA Enforcement Examples - Where Others Have Gone Wrong

  • Speaker: Jim Sheldon-Dean
  • Product ID: 703900
  • Duration: 90 Min
This HIPAA training will outline the new rules and significantly higher fines, including mandatory minimum fines of $10,000, for willful neglect of compliance. HIPAA enforcement has taken on a new importance at HHS; officials have publicly stated that enforcement is now a priority, and that means being ready for an audit or compliance review is more important than ever.
CD/Recorded
$179
Recorded/CD
Creating Proper User Requirement Specifications (URS) for Computer Systems Validation (CSV) - Ensuring Overall Regulatory Compliance

Creating Proper User Requirement Specifications (URS) for Computer Systems Validation (CSV) - Ensuring Overall Regulatory Compliance

  • Speaker: Gaurav Walia
  • Product ID: 704370
  • Duration: 75 Min
This training program will provide attendees with the ultimate set of tools in order to help their firms properly create User Requirement Specifications (URS) for Computer Systems Validation (CSV) with emphasis on current industry trends in this particular area as well as current Food and Drug Administration (FDA) regulatory trends and enforcement activity.
CD/Recorded
$229
Recorded/CD
Bulletproof Workplace Investigations

Bulletproof Workplace Investigations

  • Speaker: Cathleen M. Hampton
  • Product ID: 703734
  • Duration: 90 Min
This webinar will train attendees on carrying out effective and lawful workplace investigations. Human resources managers and others charged with conducting workplace investigations will learn effective strategies for investigating complaints made by or against an employee. This webinar will offer guidance on how best to proceed and how to achieve a meaningful outcome for all involved.
CD/Recorded
$149
Recorded/CD
Process Robustness: The New FDA Paradigm

Process Robustness: The New FDA Paradigm

  • Speaker: Angela Dunston
  • Product ID: 703990
  • Duration: 90 Min
In this training program, attendees will learn how process robustness tools and metrics can be utilized to enhance process understanding and control. The new FDA paradigm is shifting to the expectation that organizations certified by other standards such as ISO and EFfCI demonstrate process robustness. It is the obligation of the primary pharmaceutical provider to ensure process robustness throughout the supply chain.
CD/Recorded
$229
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