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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
Monitoring Plans: 10 Rules of Effective Writing of Monitoring Plans

Monitoring Plans: 10 Rules of Effective Writing of Monitoring Plans

  • Speaker: Laura Brown
  • Product ID: 703929
  • Duration: 60 Min
This training program will discuss latest requirements for monitoring plans, content and process requirements including FDA monitoring guidance and EU requirements. The webinar will help, sponsors, and CROs in the US, EU and internationally, understand how to effectively draft monitoring plans and comply with the latest FDA and EU inspection requirements for monitoring clinical trials.
CD/Recorded
$229
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Recorded/CD
CLIA (Clinical Laboratory Improvement Amendments) Guidelines on Quality Control and Quality Assessment

CLIA (Clinical Laboratory Improvement Amendments) Guidelines on Quality Control and Quality Assessment

  • Speaker: Barry Craig
  • Product ID: 701305
  • Duration: 60 Min
This Clinical Laboratory Improvement Amendments (CLIA) training will be valuable to CLIA regulated, non-waived laboratories that run automated analyzers or semi-quantitative kit tests. It will highlight differences between quality control and quality assessment and the proper methods to meet CLIA guidelines.
CD/Recorded
$179
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Recorded/CD
Workplace Investigations

Workplace Investigations

  • Speaker: Diana Chomichuk
  • Product ID: 703497
  • Duration: 60 Min
This webinar will provide attendees tools and tips for conducting workplace investigations that are fair, third-party objective, and legally defensible. It will explain the essential elements of an effective investigation.
CD/Recorded
$149
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Recorded/CD
Superiority, Non-inferiority, or Equivalence Trials: How, Why and When

Superiority, Non-inferiority, or Equivalence Trials: How, Why and When

  • Speaker: Rita Hanover
  • Product ID: 702591
  • Duration: 60 Min
This webinar on clinical study design will explore the differences among superiority, Non-inferiority (NI), and equivalence trials, including development of the precise research questions necessary to making a decision about appropriate clinical designs.
CD/Recorded
$229
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Recorded/CD
Nutraceuticals/Dietary Supplements: FDA Regulatory Submission and Manufacturing Quality Requirements

Nutraceuticals/Dietary Supplements: FDA Regulatory Submission and Manufacturing Quality Requirements

  • Speaker: Gretchen Bowker
  • Product ID: 702741
  • Duration: 60 Min
This dietary supplements quality compliance training will review the FDA regulatory requirements for manufacturing and commercialization of dietary supplements. You will gain a complete understanding of FDA requirements for manufacturing of nutraceuticals, food drugs, and dietary supplements.
CD/Recorded
$229
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Recorded/CD
FCC 740 and When to Disclaim

FCC 740 and When to Disclaim

  • Speaker: Alvaro Gutierrez
  • Product ID: 703918
  • Duration: 90 Min
This training program will detail the functions of the Federal Communications Commission (FCC) and the Telecommunications Certification Body (TCB). It will breakdown the contents of the FCC Form 740 and offer guidance for effectively completing the form.
CD/Recorded
$149
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Recorded/CD
Affordable Care Act New Tax Penalties: Impact on Individuals and Employers

Affordable Care Act New Tax Penalties: Impact on Individuals and Employers

  • Speaker: Cherie Hennig
  • Product ID: 703686
  • Duration: 120 Min
This webinar will instruct participants on the new penalties issued to individuals and employers who lack coverage altogether or whose healthcare coverage fails to meet Affordable Care Act (ACA) standards. Attendees will also learn how to compute the required annual payment, i.e., the shared responsibility payment. This two-hour webinar will focus on requirements set forth for individuals and employers filing the new form 1095-C.
CD/Recorded
$149
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Recorded/CD
How to Conduct an Internal Investigation - Vital Piece of EEO Compliance

How to Conduct an Internal Investigation - Vital Piece of EEO Compliance

  • Speaker: Gayla Sherry
  • Product ID: 703826
  • Duration: 60 Min
No two investigations are the same – even a seasoned veteran who has handled discrimination complaints and conducted internal investigations can still benefit from a deeper understanding of how to ensure EEO compliance. The risk of not properly conducting an investigation is substantial in terms of fines, penalties and settlements, but also court costs and deterioration in the organization’s reputation. This webinar will present plain language ideas for conducting investigations.
CD/Recorded
$149
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Recorded/CD
Don't be Blindsided by ERISA: Understand Your Fiduciary Responsibilities to Your Health and Retirement Plans

Don't be Blindsided by ERISA: Understand Your Fiduciary Responsibilities to Your Health and Retirement Plans

  • Speaker: Steve Flores
  • Product ID: 703522
  • Duration: 60 Min
This webinar will focus on the key elements that employers need to know in order to avoid potential fiduciary liability under Employee Retirement Income Security Act (ERISA). It will cover who is a fiduciary, the responsibilities of fiduciaries and how to implement safeguards to reduce the potential for ERISA liability.
CD/Recorded
$149
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Recorded/CD
Fraud in Clinical Research

Fraud in Clinical Research

  • Speaker: David Lim
  • Product ID: 703899
  • Duration: 60 Min
This training program will instruct attendees to better understand ethical and legal requirements when conducting medical/clinical research and study. The webinar will focus on what/how to identify, address and prevent fraud in medical research.
CD/Recorded
$149
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Recorded/CD
FDA vs. EU Inspections - Getting Prepared and What are Differences

FDA vs. EU Inspections - Getting Prepared and What are Differences

  • Speaker: Marie Dorat
  • Product ID: 703516
  • Duration: 75 Min
This webinar will help attendees understand the FDA and EU inspection process and how to prepare for both of them. Attendees will learn the best practices to respond to Form 483 citations, Warning Letters and EU inspection findings.
CD/Recorded
$229
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Recorded/CD
FDA Guidance on RUO (Research Use Only)/IUO (Investigational Use Only) Products

FDA Guidance on RUO (Research Use Only)/IUO (Investigational Use Only) Products

  • Speaker: Dev Raheja
  • Product ID: 703898
  • Duration: 60 Min
This FDA guidance training on RUO (Research Use Only) and IUO (Investigational Use Only) products will enumerate FDA requirements for research use only and investigational use only IVD products. The webinar instructor, an industry expert, will highlight appropriate labeling and distribution practices for RUO and IUO products and detail instructions for use of an IVD product labeled RUO or IUO.
CD/Recorded
$25
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Recorded/CD
Export to Mexico Documentation and Procedures

Export to Mexico Documentation and Procedures

  • Speaker: Rossano V Gerald
  • Product ID: 703917
  • Duration: 90 Min
This training program will detail appropriate multiple trade agreements that importers and exporters require when conducting trade transactions, focusing particularly on trade requirements and procedures while exporting to Mexico. The webinar will provide import compliance materials that examine U.S. Customs and Border Protection regulations for record keeping that can be used in the international logistic arena.
CD/Recorded
$149
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Recorded/CD
Common Pitfalls in Wage and Hour Compliance

Common Pitfalls in Wage and Hour Compliance

  • Speaker: Gayla Sherry
  • Product ID: 703913
  • Duration: 60 Min
This training program will offer an overview of the Fair Labor Standards Act (FLSA) which is the guiding law pertaining to classification, deductions, travel time, not tracking hours worked and misclassifying independent contractors. It will also focus on leading wage and hour violations. Recent case histories will also be reviewed for emphasis.
CD/Recorded
$149
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Recorded/CD
Social Media for FDA Regulated Industry: Navigating the Web of Rules and Guidance

Social Media for FDA Regulated Industry: Navigating the Web of Rules and Guidance

  • Speaker: Michael Walsh
  • Product ID: 703466
  • Duration: 60 Min
This webinar will provide an overview of regulations for the use of social media for promoting FDA regulated products. Attendees will learn how to comply with these regulations and avoid enforcement actions.
CD/Recorded
$229
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Recorded/CD
Health Canada's Enforcement of the Regulatory Requirements for the Manufacture, Advertising and Sale of Foods and Beverages

Health Canada's Enforcement of the Regulatory Requirements for the Manufacture, Advertising and Sale of Foods and Beverages

  • Speaker: Sara Zborovski
  • Product ID: 703852
  • Duration: 60 Min
Health Canada takes an active role in ensuring compliance with the regulatory requirements for advertising, marketing and selling food in Canada. In addition to rules to ensure the safety of food for Canadians, there are strict rules to ensure that manufacturers do not make false or misleading representations about food to Canadian consumers. This training program will introduce participants to various key legislations and its regulators, and discuss regulatory measures to ensure compliance.
CD/Recorded
$229
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Recorded/CD
Clinical Trial Liability Lawsuits

Clinical Trial Liability Lawsuits

  • Speaker: Jonathan Mcdermed
  • Product ID: 703645
  • Duration: 60 Min
This hour-long session will provide insights on liabilities arising due to non-compliance and oversight in clinical trials. The clinical affairs expert will also discuss identifying the types of litigation and how best to eliminate the source of risk with real world examples. Participants will learn to appreciate the importance of formal training in conducting proficient clinical trials.
CD/Recorded
$229
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Recorded/CD
Compliant and Effective Recruiting Including Compliance Challenges with Passive Candidates (NJ, PA, DE and NY State Regulations)

Compliant and Effective Recruiting Including Compliance Challenges with Passive Candidates (NJ, PA, DE and NY State Regulations)

  • Speaker: Deborah E Watson
  • Product ID: 703693
  • Duration: 90 Min
This course will highlight the key components of an effective and compliant recruiting process and discuss federal and state regulations that impact recruiting. The webinar instructor, a senior human resource executive and business strategist, will also analyze the challenges in passive candidate recruiting.
CD/Recorded
$149
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Recorded/CD
Qualified vs. Non-Qualified Deferred Compensation Plan - 409A, ERISA and Govt. Filing Requirements

Qualified vs. Non-Qualified Deferred Compensation Plan - 409A, ERISA and Govt. Filing Requirements

  • Speaker: Steve Flores
  • Product ID: 703666
  • Duration: 60 Min
This presentation will provide you with a good foundation to help you design and administer these nonqualified deferred compensation plans in a legally compliant manner. You will learn the differences between qualified and non-qualified plans, ERISA, 409A & Govt. filing requirments.
CD/Recorded
$149
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Recorded/CD
HIPAA Security and Breach Notification Rules - Protecting Security of PHI

HIPAA Security and Breach Notification Rules - Protecting Security of PHI

  • Speaker: Jim Sheldon-Dean
  • Product ID: 703869
  • Duration: 90 Min
Staying HIPAA compliant entails ensuring you have the right policies, procedures, and documentation, and have performed the appropriate risk analysis of confidentiality, integrity, and availability of the electronic protected health information (PHI). This course will discuss how to create the right breach notification policy for your organization and how to follow through when an incident occurs. In addition, a policy framework to help establish good security practices will be presented.
CD/Recorded
$229
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