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
Developing a Customs Compliance Program Under the Reasonable Care Standard

Developing a Customs Compliance Program Under the Reasonable Care Standard

  • Speaker: Chris Pey
  • Product ID: 704498
  • Duration: 60 Min
This training program will discuss the reasonable care standard and its history. It will analyze customs penalty laws and regulations and illustrate customs penalty examples and audit examples. The program will also highlight best practices for revising your workflows to best fit customs’ expectations.
CD/Recorded
$0
Recorded/CD
3D Printing for Manufacturing Regulated Products: FDA's Current Acceptance and Future Projections

3D Printing for Manufacturing Regulated Products: FDA's Current Acceptance and Future Projections

  • Speaker: Mukesh Kumar
  • Product ID: 703621
  • Duration: 60 Min
The webinar will discuss the current available regulatory pathways to develop FDA-regulated 3D printed products and also predictions on what to expect in the near future. 3D printing in personalized treatments will be discussed and attendees will be provided practical tips for pursuing approval with the FDA.
CD/Recorded
$229
Recorded/CD
3-Hour Virtual Training: Russia Regulatory Compliance Requirements for Life Science Products

3-Hour Virtual Training: Russia Regulatory Compliance Requirements for Life Science Products

  • Speaker: Robert J Russell
  • Product ID: 704356
  • Duration: 3 hrs
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
$429
Recorded/CD
Can Your Use of Criminal Records Pave the Way for Lawsuits - EEOC Laws and Compliance

Can Your Use of Criminal Records Pave the Way for Lawsuits - EEOC Laws and Compliance

  • Speaker: Lester S Rosen
  • Product ID: 704492
  • Duration: 75 Min
This webinar will explain the EEOC requirements and guidance on criminal records used for background checks and employment screening for the hiring process. It will discuss the new changes, opportunity and challenges of the updated EEOC guidance and how to be compliant. Instructor will discuss legal aspects of obtaining and using criminal records for hiring, EEOC best practices and ten steps an employer can take immediately to promote safe hiring.
CD/Recorded
$0
Recorded/CD
Mexico Maquiladora/IMMEX and their Free Trade Agreements

Mexico Maquiladora/IMMEX and their Free Trade Agreements

  • Speaker: John Armonda
  • Product ID: 704503
  • Duration: 60 Min
This training program will cover Maquiladora formation and regulations, IMMEX registration requirements, NAFTA Certificate of Origin, combining IMMEX and NAFTA, and more.
CD/Recorded
$199
Recorded/CD
E-Verify Compliance Essentials

E-Verify Compliance Essentials

  • Speaker: Mary Gormandy White
  • Product ID: 704489
  • Duration: 60 Min
This webinar is designed to help you get started with E-Verify and prepares you to properly implement the system in your organization. Instructor will explain reasons to use E-Verify and its benefits, how to enroll and how the E-Verify system works. Participants will also learn how E-Verify interact with I-9 requirements and the compliance considerations.
CD/Recorded
$249
Recorded/CD
How to Write Employee Documentation to Stand Up in Court

How to Write Employee Documentation to Stand Up in Court

  • Speaker: Vanessa G Nelson
  • Product ID: 704320
  • Duration: 60 Min
This training program will focus on isolating employee documentation issues and addressing them to make sure your organization stays prepared in the event of workplace litigation.
CD/Recorded
$229
Recorded/CD
The Federal False Claims Act and the Anti-Kickback Statute: Healthcare Organizations Are at Risk

The Federal False Claims Act and the Anti-Kickback Statute: Healthcare Organizations Are at Risk

  • Speaker: William Mack Copeland
  • Product ID: 704482
  • Duration: 60 Min
This training session will provide an overview of the Federal Civil False Claims Act (FCA) and how it works. It will also provide an assessment of enforcement activities, showing how participants may be at risk. In addition, the session will review recent cases and show how they potentially impact participants. The course will provide an in-depth review of the AKS (Anti-Kickback Statute) and review various cases to show how easy it is to run afoul of the statute, and how the courts view compliance with it.
CD/Recorded
$229
Recorded/CD
New Affordable Care Act Compliance Update: How to Meet Employer Reporting Requirements

New Affordable Care Act Compliance Update: How to Meet Employer Reporting Requirements

  • Speaker: Cathleen M. Hampton
  • Product ID: 704322
  • Duration: 90 Min
This training program will discuss the basics of the ACA, the timeline for your next steps in implementing the provisions of the Act, and key things employers should already be engaged in with their brokers.
CD/Recorded
$249
Recorded/CD
Design Inputs Design Outputs Traceability Matrix - Principles of Lean Documents and Lean Configuration

Design Inputs Design Outputs Traceability Matrix - Principles of Lean Documents and Lean Configuration

  • Speaker: Jose Mora
  • Product ID: 703321
  • Duration: 60 Min
This webinar will explain how to apply the theory of lean documents and its corollary theory of lean configuration to present a fresh approach to these linked and cascading documents.
CD/Recorded
$179
Recorded/CD
Tax Provision Compliance for Affordable Care Act for Employers : ACA, 1095-C, 1094-C, W9 & 941

Tax Provision Compliance for Affordable Care Act for Employers : ACA, 1095-C, 1094-C, W9 & 941

  • Speaker: JeFreda Brown
  • Product ID: 703986
  • Duration: 90 Min
This training program will detail important requirements of the Affordable Care Act tax provisions. Attendees will learn how to stay compliant with the ACA tax provisions and avoid penalties.
CD/Recorded
$199
Recorded/CD
FMLA and the Flu

FMLA and the Flu

  • Speaker: Mary Gormandy White
  • Product ID: 704461
  • Duration: 60 Min
This training program will clarify the circumstances under which illnesses expected to have relatively short durations – such as the flu – meet this definition of serous health condition and would therefore obligate employers to provide workers with Family Medical Leave (FML) time in a manner consistent with the law. Employers must know how “serious health condition” is defined under FMLA, and must provide FML accordingly in order to remain in compliance with FMLA.
CD/Recorded
$249
Recorded/CD
GMP Data Integrity Best Practices and Regulatory Expectations for the Pharmaceutical Industry

GMP Data Integrity Best Practices and Regulatory Expectations for the Pharmaceutical Industry

  • Speaker: Angela Dunston
  • Product ID: 704454
  • Duration: 90 Min
This training program will discuss MHRA GMP data integrity definitions and guidance. It will also highlight the difference between intentional and unintentional failures of data integrity and examine how regulatory agencies detect data integrity problems.
CD/Recorded
$229
Recorded/CD
Unemployment: How to Fight Unemployment Claims and Win!

Unemployment: How to Fight Unemployment Claims and Win!

  • Speaker: Vanessa G Nelson
  • Product ID: 703872
  • Duration: 60 Min
This training program is a must attend for employers to ensure they are contesting unemployment claims appropriately and consistently, as well as, to avoid higher tax rates and unemployment payments.
CD/Recorded
$149
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
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