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
Introduction to Country of Origin

Introduction to Country of Origin

  • Speaker: Randi Waltuck Barnett
  • Product ID: 704193
  • Duration: 90 Min
This training program will discuss the historical background, legal framework, and overall concepts of origin. It will also highlight the difference between non-preferential and preferential origin and guide attendees in making origin determinations for imports and exports.
CD/Recorded
$149
Recorded/CD
US Controls on Exports Abroad and Re-Exports: Understand the Regulatory and Administrative Concerns

US Controls on Exports Abroad and Re-Exports: Understand the Regulatory and Administrative Concerns

  • Speaker: Matilda Vasquez
  • Product ID: 705010
  • Duration: 60 Min
This training program will offer an overview of the Foreign Trade Regulations, the 10 General Prohibitions of the Export Administration Regulations, Office of Foreign Assets Controls and the International Traffic in Arms Regulations. It will also offer insight into exports abroad, transshipment and re-export regulations and practices.
CD/Recorded
$179
Recorded/CD
US Export Filing Requirements and the Proper Use of EAR 99

US Export Filing Requirements and the Proper Use of EAR 99

  • Speaker: Grant Smith
  • Product ID: 705004
  • Duration: 60 Min
Exports are governed by the Bureau of Industry and Security (BIS), under the US Department of Commerce. Exports are regulated by the type of export, the value of the export, and the destination of the export. These factors will help determine the documents needed, and the filings needed to legally export. This webinar training will cover US export filing requirements and the proper use of EAR 99. Failure to follow requirements can result in costly customs holds and or fines/penalties.
CD/Recorded
$0
Recorded/CD
AML Risks in Correspondent Banking: What You Need to Know for 2017

AML Risks in Correspondent Banking: What You Need to Know for 2017

  • Speaker: Joe Soniat
  • Product ID: 704997
  • Duration: 60 Min
Correspondent banking has become a hot topic with BSA AML over the past few years. With examination scrutiny on correspondent banking high, this training program will highlight why it is essential to know the risk and what to do when it comes to banking other banks.
CD/Recorded
$279
Recorded/CD
Let's Get Back to Basics:  Withholding, Depositing and Reporting Federal Taxes

Let's Get Back to Basics: Withholding, Depositing and Reporting Federal Taxes

  • Speaker: Vicki M. Lambert
  • Product ID: 704182
  • Duration: 90 Min
This webinar will cover the basics of withholding, depositing, paying and reporting payroll taxes. It will provide a good solid foundation for the payroll beginner or an excellent refresher course for the seasoned professional.
CD/Recorded
$299
Recorded/CD
What Employers Need to Know About Severance Arrangements - EEOC, ACA and ERISA

What Employers Need to Know About Severance Arrangements - EEOC, ACA and ERISA

  • Speaker: Janette Levey Frisch
  • Product ID: 703780
  • Duration: 90 Min
This webinar will highlight the importance of effectively handling severance pay and agreements. It will discuss several frequently asked questions on employee termination, severance pay, severance agreements, and ERISA laws.
CD/Recorded
$229
Recorded/CD
Auditing of Environmental, Health and Safety programs for the non-technical auditor

Auditing of Environmental, Health and Safety programs for the non-technical auditor

  • Speaker: Lynn Fountain
  • Product ID: 703131
  • Duration: 90 Min
This training on EH&S compliance will provide you the powerful tools for building successful audit program for environmental health and safety concerns to ensure compliance with EPA and OSHA policies.
CD/Recorded
$0
Recorded/CD
Structuring Physician Employment Agreements: Key Legal Considerations

Structuring Physician Employment Agreements: Key Legal Considerations

  • Speaker: Joseph Wolfe
  • Product ID: 704716
  • Duration: 60 Min
In this training session, the instructor will provide an overview of Stark Law, including its 2016 changes. He will also discuss best practices for negotiating and drafting physician employment agreements on behalf of health systems, hospitals and medical groups. He will explain key provisions and potential pitfalls in both types of agreements.
CD/Recorded
$249
Recorded/CD
Procurement and Contract Fraud - Detection and Prevention

Procurement and Contract Fraud - Detection and Prevention

  • Speaker: John E Grimes
  • Product ID: 704334
  • Duration: 90 Min
This training program will examine the fraud vulnerabilities in the procurement of materials and services in the private sector. In addition, it will explore the many procurement and contract fraud schemes and at what point in the procurement and contract process they occur.
CD/Recorded
$179
Recorded/CD
ISO 45001 - Mitigation Essentials - Part 1

ISO 45001 - Mitigation Essentials - Part 1

  • Speaker: Michael Aust
  • Product ID: 704939
  • Duration: 60 Min
This webinar will discuss about safety management system and ISO 45001, and how and why 100,000 companies are expected to comply by 2019. Also, this webinar will provide an overview of the new/updated concept of ISO 45001 along with the comparison of OHSAS 18001:2007 to ISO 45001. Furthermore, we will also discuss a three year mitigation process for organizations already 18001 certified.
CD/Recorded
$0
Recorded/CD
Risk-based Approach to Biopharmaceutical Method Transfers

Risk-based Approach to Biopharmaceutical Method Transfers

  • Speaker: Jeffrey Staecker
  • Product ID: 705049
  • Duration: 60 Min
This Webinar will discuss how non-compendial biopharmaceutical analytical method transfers can leverage a risk-based approach to address Quality and Regulator concerns. Method transfers using a statistical equivalence approach with tight criteria as frequently suggested by regulators makes it difficult to transfer methods and can result in a high transfer failure rate.
CD/Recorded
$0
Recorded/CD
Compliance with Brexit's Impact on the Global Pharmaceutical industry

Compliance with Brexit's Impact on the Global Pharmaceutical industry

  • Speaker: Laura Brown
  • Product ID: 705047
  • Duration: 60 Min
Pharmaceutical companies will need to develop strategies for their drug programmes to deal with Brexit. This webinar will provide an essential understanding to help develop a strategy for managing Brexit.
CD/Recorded
$0
Recorded/CD
Quality by Design

Quality by Design

  • Speaker: Heath Rushing
  • Product ID: 705051
  • Duration: 60 Min
This training program will guide attendees in implementing QbD principles from discovery through product discontinuation. It will also illustrate applying statistics to set specifications and validate measurement systems (assays) and discuss utilizing risk management tools to identify and prioritize potential critical process parameters.
CD/Recorded
$0
Recorded/CD
Reimbursement Requirements for Designing Innovative Devices

Reimbursement Requirements for Designing Innovative Devices

  • Speaker: Tom Kramer
  • Product ID: 704625
  • Duration: 60 Min
This training program will highlight key metrics needed to convince reimbursement panels of design compliance and discuss how best to implement practices in your development process that ensure acceptance by reimbursement groups.
CD/Recorded
$0
Recorded/CD
How to prepare a 510(k) FDA Submission

How to prepare a 510(k) FDA Submission

  • Speaker: Edwin Waldbusser
  • Product ID: 705024
  • Duration: 60 Min
This 510(k) training will discuss the submission process and the contents required by the FDA for a successful 510(k) submission.
CD/Recorded
$0
Recorded/CD
TSCA Reform - Immediate Actions Required

TSCA Reform - Immediate Actions Required

  • Speaker: Rose Passarella
  • Product ID: 705036
  • Duration: 60 Min
This webinar will provide an overview of the new law and major changes to Toxic Substances Control Act (TSCA). All chemical stakeholders doing business in the U.S. will need to understand the fundamental shifts in requirements, the new concepts and approaches that are introduced by the law, and the timetable that the U.S. Environmental Protection Agency (EPA) must follow in implementing the new law.
CD/Recorded
$249
Recorded/CD
Audits - Seven reasons they don't work

Audits - Seven reasons they don't work

  • Speaker: Susanne Manz
  • Product ID: 705042
  • Duration: 90 Min
Continuous Improvement starts with awareness of issues and opportunities. And without an effective internal audit program, management lacks awareness of the issues within their quality system. Management is blind to the gaps in the quality system and the risk that poses for the company. Even worse, management is blind to the impact on product quality and risk to the customer. This webinar will highlight red-flags and ways reduce compliance and quality risk.
CD/Recorded
$0
Recorded/CD
Ethical Dilemmas in Food Policy

Ethical Dilemmas in Food Policy

  • Speaker: Darin Detwiler
  • Product ID: 705034
  • Duration: 90 Min
This webinar sheds light on the changes in the political, economic and judicial landscape of the food industry. Landmark food industry events over the last two decades highlight the evolution of the challenges and consequences related to ethical dilemmas in the food industry. This webinar covers the elements of food systems, economics of failure, true burden of disease, case studies from industry and regulatory agencies.
CD/Recorded
$219
Recorded/CD
OSHA Recordkeeping for 2017: Beyond the OSHA 300 Summary

OSHA Recordkeeping for 2017: Beyond the OSHA 300 Summary

  • Speaker: David A Casavant
  • Product ID: 703492
  • Duration: 90 Min
This webinar will focus on the OSHA recordkeeping requirements. Attendees will learn how to ensure compliance with these regulations and avoid OSHA citations and fines.
CD/Recorded
$149
Recorded/CD
Moving FDA Boundaries for Direct-to-Consumer Advertising

Moving FDA Boundaries for Direct-to-Consumer Advertising

  • Speaker: Casper Uldriks
  • Product ID: 705033
  • Duration: 90 Min
FDA encourages companies that offer DTC advertising to include accurate information in their ads. Through a comprehensive surveillance and enforcement program, the agency ensures that consumers are not misled or deceived by advertisements that violate the law. This webinar will bring attendees up to speed so you are clearer about when DTC advertising makes you ripe for legal picking by the FDA.
CD/Recorded
$179
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