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
FDA Regulation of Therapeutic Use of Live Cells

FDA Regulation of Therapeutic Use of Live Cells

  • Speaker: Igor Zlatkin
  • Product ID: 703463
  • Duration: 60 Min
This webinar will discuss the FDA rules and regulations regarding the potential of using live cells in medicine. It will cover FDA guidance documents for cellular and gene therapy and major differences between the rules in the USA and other countries.
CD/Recorded
$229
Recorded/CD
Current Hot Topics in Customs Valuation

Current Hot Topics in Customs Valuation

  • Speaker: George Tuttle
  • Product ID: 703458
  • Duration: 90 Min
This CBP compliance webinar will discuss how to identify critical areas of customs valuation that are often overlooked by importers and customs brokers. Attendees will learn best practices for avoiding costly investigations, audits as well as monetary penalties.
CD/Recorded
$149
Recorded/CD
Essentials of Taxing and Reporting Insurance Benefits in 2014 and Beyond

Essentials of Taxing and Reporting Insurance Benefits in 2014 and Beyond

  • Speaker: Vicki M. Lambert
  • Product ID: 703350
  • Duration: 90 Min
This webinar will explain in detail the reporting requirements under the Affordable Health Care Act, calculating group term life insurance and tax ramifications of third party sick pay. Attendees will gain an understanding of the different types of health plans outside of the typical group health insurance and how each must be handled and reported on Form W-2.
CD/Recorded
$149
Recorded/CD
Dual and Third-Country Nationals: Ensuring Foreign Licensee Requirements to Prevent Diversion of ITAR-Controlled Defense Articles

Dual and Third-Country Nationals: Ensuring Foreign Licensee Requirements to Prevent Diversion of ITAR-Controlled Defense Articles

  • Speaker: Darrell Coleman
  • Product ID: 703454
  • Duration: 70 Min
This webinar will explain the requirements of ITAR 126.18 regarding the transfer of defense articles (including technical data) to dual and third-country nationals employed by approved foreign end-users. Attendees will learn how to ensure compliance with the ITAR and avoid violations and penalties.
CD/Recorded
$149
Recorded/CD
Site Preparation Strategy and Successful FDA Inspection

Site Preparation Strategy and Successful FDA Inspection

  • Speaker: Yasamin Ameri
  • Product ID: 703441
  • Duration: 60 Min
This webinar will explain the Good Manufacturing Practices (GMP) requirements. Attendees will learn strategies for site preparation and hosting of an inspection.
CD/Recorded
$229
Recorded/CD
Selecting the Most Appropriate Predicate Device(S) for your 510(k) Application

Selecting the Most Appropriate Predicate Device(S) for your 510(k) Application

  • Speaker: Cheryl Wagoner
  • Product ID: 703438
  • Duration: 60 Min
This webinar will provide tips and techniques on how to research and identify appropriate predicate devices for a 510(k) application.
CD/Recorded
$229
Recorded/CD
Data Management SOPs

Data Management SOPs

  • Speaker: Adam Ruskin
  • Product ID: 703376
  • Duration: 60 Min
This webinar will teach attendees how to develop more efficient data management SOPs for their company, whether they perform these tasks in-house, oversee this task that a vendor provides, or outsource this task in its entirety.
CD/Recorded
$50
Recorded/CD
Current FMLA and ADA Issues for Managers

Current FMLA and ADA Issues for Managers

  • Speaker: Max Muller
  • Product ID: 703429
  • Duration: 60 Min
This webinar will address current HR issues regarding the FMLA and ADA. It will discuss the common mistakes that managers make when applying these laws and how to avoid them.
CD/Recorded
$149
Recorded/CD
Equipment Requalification: What and When it is Really Required?

Equipment Requalification: What and When it is Really Required?

  • Speaker: Jennifer Medlar
  • Product ID: 703450
  • Duration: 60 Min
This webinar will explain how to generate a practical and compliant methodology to handle equipment requalification. Attendees will learn about common pitfalls to avoid when requalifying equipment.
CD/Recorded
$229
Recorded/CD
Foreign Corrupt Practices Act - Critical Issues and Best Practices

Foreign Corrupt Practices Act - Critical Issues and Best Practices

  • Speaker: Andrea Ewart
  • Product ID: 703167
  • Duration: 90 Min
This training on the Foreign Corrupt Practices Act will focus on the anti-bribery and accounting provisions of the FCPA and will explain the activities and conducts that are prohibited by the FCPA. Learn the best practices and strategies for avoiding criminal and administrative penalties for violating its provisions.
CD/Recorded
$149
Recorded/CD
Issues - Terminations and Exits - Legal Compliance

Issues - Terminations and Exits - Legal Compliance

  • Speaker: Diana Chomichuk
  • Product ID: 703428
  • Duration: 60 Min
This webinar will explain how to manage employee terminations and exits. Attendees will gain understanding and discover recommended best practices and techniques for ensuring compliance, fairness, and reasonable support during sensitive employee terminations and exits.
CD/Recorded
$149
Recorded/CD
FAA Procedures for Transportation Workplace Drug and Alcohol Testing Programs

FAA Procedures for Transportation Workplace Drug and Alcohol Testing Programs

  • Speaker: Butch Wilson
  • Product ID: 703456
  • Duration: 60 Min
This webinar will discuss the required procedures for conducting workplace drug and alcohol testing for the federally regulated transportation industry. Attendees will learn how to ensure compliance with the FAA's Drug and Alcohol Testing Regulation.
CD/Recorded
$149
Recorded/CD
Regulatory Records Primer:  Decoding the Requirements for Medical Device and Pharmaceutical Manufacturers

Regulatory Records Primer: Decoding the Requirements for Medical Device and Pharmaceutical Manufacturers

  • Speaker: Les Schnoll
  • Product ID: 703433
  • Duration: 90 Min
This webinar will explain FDA regulatory records requirements for medical devices and finished pharmaceuticals. It will cover statutory requirement, required content, format, purpose, retention, and structure for regulatory records for both medical devices and pharmaceuticals.
CD/Recorded
$50
Recorded/CD
Quality Systems Approach for Validation and Maintenance of a Global ERP System

Quality Systems Approach for Validation and Maintenance of a Global ERP System

  • Speaker: James Carron
  • Product ID: 703424
  • Duration: 90 Min
This webinar will explain how to implement an Enterprise Resource Planning (ERP) system by integrating a company’s existing quality system. It will cover selection, analysis, initiation, design, validation and test phases, including change control.
CD/Recorded
$50
Recorded/CD
Adverse Event Reporting Requirements for Dietary Supplements and OTC Drugs

Adverse Event Reporting Requirements for Dietary Supplements and OTC Drugs

  • Speaker: Mukesh Kumar
  • Product ID: 703422
  • Duration: 90 Min
This webinar will discuss regulatory requirements for adverse event reporting for dietary supplements and OTC products. It will explain the similarities and differences in reporting adverse events for dietary supplements and OTC products and will also discuss trends in FDA audit for these products.
CD/Recorded
$229
Recorded/CD
The New European Union Clinical Trials Regulation:  An Analysis of the Key Changes and their Implications for Future Clinical Trials

The New European Union Clinical Trials Regulation: An Analysis of the Key Changes and their Implications for Future Clinical Trials

  • Speaker: Ciara Farrell,Elisabethann Wright
  • Product ID: 703445
  • Duration: 60 Min
This webinar will review the changes introduced by the new European Union ("EU") Clinical Trials Regulation and the implications for future clinical trials.
CD/Recorded
$229
Recorded/CD
OSHA Refresher Course - Electrical Safety Compliance

OSHA Refresher Course - Electrical Safety Compliance

  • Speaker: Leo Muckerheide
  • Product ID: 702424
  • Duration: 90 Min
This webinar will help you understand the applicable electrical safety practices in the workplace and review the responsibilities and requirements for a person qualified in the OSHA and National Fire Protection Association’s (NFPA) standards.
CD/Recorded
$50
Recorded/CD
LDT including CDx; CLIA versus FDA's Authority

LDT including CDx; CLIA versus FDA's Authority

  • Speaker: Abdel Halim
  • Product ID: 703399
  • Duration: 60 Min
This webinar will explain the regulatory path of an in vitro diagnostic (IVD) and Laboratory Developed Test (LDT). It will discuss the CLIA regulations for Laboratory Developed Tests (LDTs), including companion diagnostics (CDx) and how these differ from the FDA’s authority.
CD/Recorded
$229
Recorded/CD
Business Associate Agreements (BAA): Why the Pushback from Business Associates

Business Associate Agreements (BAA): Why the Pushback from Business Associates

  • Speaker: Tom Dumez
  • Product ID: 703397
  • Duration: 60 Min
This webinar will explain the requirements of the Omnibus Final Rule regarding Business Associate Agreements (BAA’s) including what it was, what it is now, and what it might be in the future. It will discuss responsibility, liability, indemnification, injunctive relief, and other topics that are causing, or may be causing, contention.
CD/Recorded
$229
Recorded/CD
Understanding OSHA - Avoiding Citations and Preparing for the Unexpected

Understanding OSHA - Avoiding Citations and Preparing for the Unexpected

  • Speaker: Paul Gogulski PE
  • Product ID: 703419
  • Duration: 90 Min
This webinar will explain how to prepare for an unannounced OSHA inspection and avoid citations and fines. Attendees will learn how to effectively use Job Hazard Analysis (JHA) to prevent accidents in the workplace.
CD/Recorded
$50
Best Sellers
You Recently Viewed
    Loading