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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
State Insurance Solvency Modernization Initiatives - Financial Crisis to Present

State Insurance Solvency Modernization Initiatives - Financial Crisis to Present

  • Speaker: Adam Kerns
  • Product ID: 704901
  • Duration: 60 Min
This webinar training will discuss the state insurance regulatory developments from 2008 through today regarding the (NAIC) Solvency Modernization Initiative (SMI). Participants who attend this webinar will receive a comprehensive, in-depth review of the various state insurance solvency modernization initiatives, along with a better understanding of how such initiatives will directly impact their daily operations.
CD/Recorded
$0
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Recorded/CD
Prove 21 CFR 820 Compliance Using Requirements Traceability

Prove 21 CFR 820 Compliance Using Requirements Traceability

  • Speaker: Russell Pizzuto
  • Product ID: 704935
  • Duration: 90 Min
This webinar will demonstrate how to use requirements tractability to systematically connect Engineering, Manufacturing and Risk Management processes, and how to systematically collect the objective evidence necessary to prove 21 CFR 820 compliance to the FDA.
CD/Recorded
$0
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Recorded/CD
Avoiding the Legal Pitfalls of Screening Applicants

Avoiding the Legal Pitfalls of Screening Applicants

  • Speaker: Susan Fahey Desmond
  • Product ID: 704277
  • Duration: 90 Min
Hiring the wrong individual can be costly in so many ways. You will be eventually looking at terminating him/her, and terminations always run the risk of a lawsuit. Hiring someone with a violent or criminal background can lead to a negligent hiring claim should the individual inflict harm on others while working for your organization. Yet, there are so many laws that say what you can or can’t do when screening your applicants. This webinar will guide participants through the legal pitfalls that come from screening applicants and how to avoid them.
CD/Recorded
$229
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Recorded/CD
2016 Presidential Political Passions and Contentions: How to Navigate Political Speech and Actions at Work

2016 Presidential Political Passions and Contentions: How to Navigate Political Speech and Actions at Work

  • Speaker: Dr. Susan Strauss
  • Product ID: 704735
  • Duration: 60 Min
Only 25% of organizations have a written policy on political activities. What laws or regulations should employers consider in setting the tone of political discussions at work, if any? This training program will address issues regarding workplace policies when it comes to political discussions among employees and employers.
CD/Recorded
$0
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Recorded/CD
Critical Elements of Quality Risk Management Relating to FDA Compliance

Critical Elements of Quality Risk Management Relating to FDA Compliance

  • Speaker: Danielle DeLucy
  • Product ID: 704829
  • Duration: 60 Min
This training program will discuss risk management and outline the requirements for applying risk management to the quality system. It will also discuss how to conduct and implement risk management practices at your firm and review communication techniques to highlight the benefits of risk management.
CD/Recorded
$0
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Recorded/CD
HIPAA Compliance in 4 Parts

HIPAA Compliance in 4 Parts

  • Speaker: Rich Devlin
  • Product ID: 704940
  • Duration: 60 Min
This webinar will discuss the 4 parts of HIPAA compliance and how it can be accomplished comprehensively. You will learn why just performing a Security Risk Analysis (SRA) using the government’s CRM tool is insufficient for compliance and can land you in jail.
CD/Recorded
$0
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Recorded/CD
Conflict of Interest in the Business Environment: Address Workplace Ethics

Conflict of Interest in the Business Environment: Address Workplace Ethics

  • Speaker: John E Grimes
  • Product ID: 704936
  • Duration: 90 Min
This webinar will help in identifying the existence of a conflict of interest. Understand the levels at which potential conflicts can exist, and the various ways in which a conflict can harm an organization. The instructor will explain the correlation between a conflict of interest and corruption, including bribery, kickbacks, and illegal or unauthorized gratuities and discuss proactive preventive and detection measures to combat this fraud hazard.
CD/Recorded
$0
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Recorded/CD
Structuring Physician Leases under the New 2016 Stark Rules

Structuring Physician Leases under the New 2016 Stark Rules

  • Speaker: Joseph Wolfe
  • Product ID: 704420
  • Duration: 60 Min
This healthcare compliance training will provide a general overview of Stark Law. It will also discuss best practices for auditing existing space lease arrangements and for implementing new time-share arrangements under the 2016 Stark rules.
CD/Recorded
$229
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Recorded/CD
Providing DMFs in eCTD format

Providing DMFs in eCTD format

  • Speaker: Peggy Berry
  • Product ID: 704934
  • Duration: 90 Min
This webinar will review the CTD format and content requirements for the DMF. It will discuss the transition from other formats to the CTD/eCTD and technical requirements for eCTD submission.
CD/Recorded
$0
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Recorded/CD
Payroll Benchmarking: Cut Costs, Improve Efficiency - 2016

Payroll Benchmarking: Cut Costs, Improve Efficiency - 2016

  • Speaker: Vicki M. Lambert
  • Product ID: 704658
  • Duration: 90 Min
This training program will cover how to set up and bench mark payroll processes in order to seek out ineffectual processes and strengthen effective ones while improving the department’s efficiency, focusing on best practices for 2016.
CD/Recorded
$0
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Recorded/CD
Federal Election Campaign Act and NLRB Crossover: How to Manage Politically-Charged Workplace

Federal Election Campaign Act and NLRB Crossover: How to Manage Politically-Charged Workplace

  • Speaker: Dr. Susan Strauss
  • Product ID: 704920
  • Duration: 60 Min
This webinar will discuss Federal Election Campaign Act , National Labor Relations Act and the workers’ rights about political speech. It will explain the legal rights and responsibilities of the workplace/employer include about political speech by the organization and management and how to diminish bias and risk of liability regarding political speech.
CD/Recorded
$0
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Recorded/CD
HIPAA and BYOD

HIPAA and BYOD

  • Speaker: Brian Tuttle
  • Product ID: 704412
  • Duration: 60 Min
This HIPAA training program will focus on the risks and issues of the use of portable devices for patient communications and accessing PHI. Areas covered will be texting, email, encryption, medical messaging, voice data and risk factors as they relate to IT.
CD/Recorded
$179
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Recorded/CD
Section 1557 of the Affordable Care Act: New Civil Rights Law for the Healthcare Industry

Section 1557 of the Affordable Care Act: New Civil Rights Law for the Healthcare Industry

  • Speaker: Dr. Susan Strauss
  • Product ID: 704923
  • Duration: 90 Min
The U. S. Department of Health and Human Services, Office for Civil Rights issued the new regulations for Section 1557 of the Affordable Care Act. This act deals with nondiscrimination in healthcare and provides important new protections for patients including broad rules dealing with sex discrimination.This webinar will guide how to implement the new law to certify decreased risk of liability, ensure quality and equitable care and insurance coverage of all patients thereby enhancing quality care of patients.
CD/Recorded
$0
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Recorded/CD
Being Prepared for a HIPAA Audit

Being Prepared for a HIPAA Audit

  • Speaker: Jay Hodes
  • Product ID: 704722
  • Duration: 60 Min
Almost 120,000,000 individuals were affected by HIPAA data breaches in 2015. This is a significant reason why Congress has inquired about the recent and very sizeable increases in cyber-attacks that inflect the risk of medical identity theft. This training program will explore how, with the Phase 2 audit program underway, selected covered entities will soon receive written notifications they are going to be audited.
CD/Recorded
$179
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Recorded/CD
Panama: The Port with Two Oceans - 10 Reasons Panama Should be Your Latin American Distribution Center

Panama: The Port with Two Oceans - 10 Reasons Panama Should be Your Latin American Distribution Center

  • Speaker: Joe Lynch
  • Product ID: 704794
  • Duration: 60 Min
This training program will discuss why US companies are opening distribution centers in Latin America. It will review typical problems encountered with Latin American distribution centers and offer an understanding of why Panama is one of the best locations for a distribution center.
CD/Recorded
$50
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Recorded/CD
3-hr Virtual Seminar - Boot Camp: Untangling the FMLA, ADAAA, GINA, and Workers Compensation Laws

3-hr Virtual Seminar - Boot Camp: Untangling the FMLA, ADAAA, GINA, and Workers Compensation Laws

  • Speaker: Susan Fahey Desmond
  • Product ID: 702172
  • Duration: 3 hrs
This 3-hr training will show how you can deal with an employee who suffers from an on the job injury and his/her leave requirements trigger rights under the FMLA and the newly amended ADAAA. You will learn when you can terminate this individual, if ever and make sure you are complying with all legal requirements when it appears that compliance with one law may mean violating the other.
CD/Recorded
$229
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Recorded/CD
Implementing the New Usability Engineering Standard

Implementing the New Usability Engineering Standard

  • Speaker: Daniel O Leary
  • Product ID: 704894
  • Duration: 90 Min
Usability Engineering has become a major topic. The current standard tightens the linkage to risk management. In addition, there are changes in the US and EU approach, all of which find a basis in this standard. Attending this presentation provides the information you need to prepare for these major changes.
CD/Recorded
$279
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Recorded/CD
Validation Master Planning - The Unstated Requirements

Validation Master Planning - The Unstated Requirements

  • Speaker: John E Lincoln
  • Product ID: 704292
  • Duration: 90 Min
This training program will focus on U.S. FDA and EU's MDD expect documented risk-based VMP planning, though the CGMPs mention little about it. The course will analyze product V&V versus process/ equipment V&V and how to use DQ, IQ, OQ, PQ, and ASTM E2500 equivalents.
CD/Recorded
$279
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Recorded/CD
Develop and Upgrade Sound Business Continuity Plans | New and Potential Threats

Develop and Upgrade Sound Business Continuity Plans | New and Potential Threats

  • Speaker: Javier Kuong
  • Product ID: 704908
  • Duration: 120 Min
This webinar will offer guidelines on how organizations should take a short-, medium-, and long-term vision of their enterprise-wide contingency and business continuity plan preparation. It will also offer best practices to upgrade your Business Continuality Plan (BCP) to cope with a whole variety of new current and forecast threats, with uncertain times of occurrence, in a dynamic business and global threat panorama.
CD/Recorded
$0
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Recorded/CD
Complying with the Rules and Regulations Pertaining to Letters of Credit: OFAC, Anti-Boycott, and the USA PATRIOT Act

Complying with the Rules and Regulations Pertaining to Letters of Credit: OFAC, Anti-Boycott, and the USA PATRIOT Act

  • Speaker: Buddy Baker
  • Product ID: 702639
  • Duration: 90 Min
This international trade compliance training will provide an overview and introduction to rules and regulations governing international trade and take an in-depth look at US sanctions enforced by the Office of Foreign Assets Control (OFAC), Anti-Boycott regulations maintained by the US Department of Commerce, and section 326 of the USA PATRIOT Act (“Know Your Customer”).
CD/Recorded
$249
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