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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
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
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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
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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
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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
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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
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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
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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
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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
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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
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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
$169
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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
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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
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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
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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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Recorded/CD
Employment and Labor Laws With Respect to Social Networking: Understanding the Cause and Effect Relationship

Employment and Labor Laws With Respect to Social Networking: Understanding the Cause and Effect Relationship

  • Speaker: Susan Fahey Desmond
  • Product ID: 705037
  • Duration: 90 Min
Every company will find at some point that it will have a problem that arises from an employee’s use of social networking sites. This training program will discuss the legal implications behind improper handling of social networking issues at the workplace, the standpoint of regulatory agencies, and drafting policies to address these concerns.
CD/Recorded
$229
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Recorded/CD
Perceptions of The Health Risks of Cosmetics, and What it means to Their Regulation

Perceptions of The Health Risks of Cosmetics, and What it means to Their Regulation

  • Speaker: Rob Ross Fichtner
  • Product ID: 704955
  • Duration: 90 Min
This webinar will discuss some of the major issues in the regulation of cosmetics. Upon completion of the session attendees will learn how regulators regulate cosmetics compared to other categories, fine line between cosmetics and drugs, and future directions for cosmetic regulations.
CD/Recorded
$179
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Recorded/CD
How the Food Safety Modernization Act Affects USDA Regulated Facilities

How the Food Safety Modernization Act Affects USDA Regulated Facilities

  • Speaker: Derrick Swint
  • Product ID: 705032
  • Duration: 90 Min
This FSMA webinar will outline key objectives for the meat and poultry industry to better understand what steps must be taken by food producers in this sector to meet, and preferably exceed, all relevant standards and regulations of the Food Safety Modernization Act (FSMA).
CD/Recorded
$0
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Recorded/CD
OSHA's Famous Top 10 List of Citations: General Industry and Construction Industry Standards

OSHA's Famous Top 10 List of Citations: General Industry and Construction Industry Standards

  • Speaker: Michael Aust
  • Product ID: 704216
  • Duration: 60 Min
This training program will review OSHA’s top 10 list of citations for general industry (29CFR1910) and construction industry (29CFR1926) - FY 2015. It will explain best practices to stay ahead of OSHA enforcement actions.
CD/Recorded
$199
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Recorded/CD
Seeking Civility? Understanding and Eradicating Workplace Bullying

Seeking Civility? Understanding and Eradicating Workplace Bullying

  • Speaker: Catherine Mattice Zundel
  • Product ID: 705000
  • Duration: 75 Min
This training program will discuss the definition of workplace bullying and detail strategies to implement a corporate policy that gets buy-in from employees. It will also discuss how to empower employees, supervisors and managers to prevent bullying and offer a wide perspective on regulatory updates on workplace bullying.
CD/Recorded
$0
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Recorded/CD
The Department of Labor's Fiduciary the New Final Rule - Best Practices for Conducting a Due Diligence and Reviewing the Best Interest Contract Exemption

The Department of Labor's Fiduciary the New Final Rule - Best Practices for Conducting a Due Diligence and Reviewing the Best Interest Contract Exemption

  • Speaker: Lisa Marsden
  • Product ID: 705021
  • Duration: 60 Min
This 60-minute training session will provide a detailed overview of the Department of Labor’s Final Fiduciary Rule including the history and on-going resistance to the rule. The session will delve into details on how the rule was established and who it will be applied to. The webinar instructor will discuss the summary of the details of the new final rule and what firms must do to comply.
CD/Recorded
$179
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