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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
Stability and Shelf Life of Medical Devices

Stability and Shelf Life of Medical Devices

  • Speaker: Stephanie Cooke
  • Product ID: 705485
  • Duration: 90 Min
This webinar will cover all relevant regulatory requirements (CFR, FDA, ISO, ASTM and European) for establishing the stability and determining the shelf-life of medical devices. Attendees will gain a better understanding of the design control process for designing medical devices.
CD/Recorded
$0
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Recorded/CD
HIPAA for Medical and Dental Offices

HIPAA for Medical and Dental Offices

  • Speaker: Kelly D Ogle
  • Product ID: 705421
  • Duration: 60 Min
The webinar will discuss the critical elements of HIPAA Privacy and Security Rule including the updated changes to the Final Rule. It will also provide best practices for the personnel in medical and dental offices to ensure compliance with HIPAA regulations.
CD/Recorded
$0
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Recorded/CD
Compliance Department Restructuring with the New Regulatory Demands

Compliance Department Restructuring with the New Regulatory Demands

  • Speaker: Carlo Chalhoub
  • Product ID: 705454
  • Duration: 60 Min
This webinar addresses recent changes in the compliance environment. It will also discuss the process for evaluating compliance department structure and the goals of compliance restructuring.
CD/Recorded
$0
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Recorded/CD
Is your Export Control Program Up to Standard? A How-to on Conducting a thorough Self-Assessment

Is your Export Control Program Up to Standard? A How-to on Conducting a thorough Self-Assessment

  • Speaker: Suzanne Bullitt
  • Product ID: 703205
  • Duration: 60 Min
This training on Export Administration Regulations (EAR) compliance will provide the attendees best practices for developing an export control program for conducting a thorough self assessment.
CD/Recorded
$149
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Recorded/CD
Transaction Monitoring and Cybersecurity - DFS, SOC, Cybersecurity Framework and Many More

Transaction Monitoring and Cybersecurity - DFS, SOC, Cybersecurity Framework and Many More

  • Speaker: William Akel
  • Product ID: 705365
  • Duration: 60 Min
Attend this webinar to understand the best ways to maintain annual compliance with DFS cybersecurity requirements through a strategic transformation of IT security monitoring to proactive cyber risk management; and to learn how a human-centric security orchestration model with people, process and technology will save and make you money.
CD/Recorded
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Recorded/CD
How to Conduct a Human Factors Validation Following ISO 62366 and the 2016 FDA Guidance

How to Conduct a Human Factors Validation Following ISO 62366 and the 2016 FDA Guidance

  • Speaker: Edwin Waldbusser
  • Product ID: 705057
  • Duration: 60 Min
This training program will examine how human factors/usability is the analysis of how people interact with medical devices. The process of conducting rigorous human factors studies throughout the design process, integrating it with the device risk analysis and design process and validating the effectiveness of the studies will be explained. The various types and methods of human factors analysis will be explained. This process conforms to the new ISO 62366 standard and the new FDA guidance document.
CD/Recorded
$249
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Recorded/CD
Medical Device CE Mark & Quality System Certification: Recent & Proposed Changes

Medical Device CE Mark & Quality System Certification: Recent & Proposed Changes

  • Speaker: John Chapman
  • Product ID: 700184
  • Duration: 60 Min
This webinar on selling medical devices in the European Union (EU) will immensely benefit companies wishing to penetrate the EU market for medical devices or sharpen their skills. It will provide practical guidance on achieving the CE mark. Medical devices sold into the European Union (EU) must comply with the applicable medical device directives and EU laws similar to FDA’s regulations.
CD/Recorded
$249
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Recorded/CD
HIPAA Updates and the Omnibus Rule

HIPAA Updates and the Omnibus Rule

  • Speaker: Jay Hodes
  • Product ID: 705181
  • Duration: 90 Min
Understand the HIPAA Omnibus Rule requirements and make sure your HIPAA compliance program is adequate and can withstand a government audit or investigation.
CD/Recorded
$179
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Recorded/CD
Develop a Device Master Record that can assist with Device History Record Review

Develop a Device Master Record that can assist with Device History Record Review

  • Speaker: Mary Nunnally
  • Product ID: 705328
  • Duration: 60 Min
This webinar provides a basic understanding of the records required to fulfill requirements of both US FDA 21CFR 820 and ISO 13485:2016 for establishment and maintenance of a Device Master Record. It will further discuss the responsibilities of various development team members such as R&D/engineering, operations, quality assurance, project management and executive management.
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Engaging Hospitalists in the Case Management Process

Engaging Hospitalists in the Case Management Process

  • Speaker: Bev Cunningham
  • Product ID: 705411
  • Duration: 60 Min
This webinar will focus on methods to ensure best-practice strategies for aligning the case management department with hospitalists’ practices. Attendees will understand the role of the hospitalist, the hospitalist group and the collaboration responsibility with the case management department—RN case managers, social workers and leadership.
CD/Recorded
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Recorded/CD
Electronic Data Integrity in a GxP Environment: Managing the Data Lifecycle for Compliance

Electronic Data Integrity in a GxP Environment: Managing the Data Lifecycle for Compliance

  • Speaker: Sarah Fowler Dixon
  • Product ID: 705451
  • Duration: 60 Min
This webinar will provide an understanding of the data integrity and data lifecycle within the GxP environment. Attendees will learn best practices to comply with the current regulations and industry standards for electronic data integrity throughout the data lifecycle.
CD/Recorded
$0
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Recorded/CD
Texting and E-mail with Patients - Meeting Patient Desires Within the HIPAA Rules

Texting and E-mail with Patients - Meeting Patient Desires Within the HIPAA Rules

  • Speaker: Jim Sheldon-Dean
  • Product ID: 702854
  • Duration: 90 Min
This HIPAA compliance training will explain how HIPAA requirements for privacy and security can be reconciled with patient requests for information to be provided by e-mail and text messages.
CD/Recorded
$179
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Recorded/CD
OSHA for Medical and Dental Offices

OSHA for Medical and Dental Offices

  • Speaker: Kelly D Ogle
  • Product ID: 705416
  • Duration: 60 Min
This webinar will discuss the most frequently found safety hazards in medical and dental offices, the OSHA requirements and standards that apply, and how to ensure compliance.
CD/Recorded
$0
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Recorded/CD
Laboratory Accreditation and Quality Management Systems Part 2: Technical Concerns

Laboratory Accreditation and Quality Management Systems Part 2: Technical Concerns

  • Speaker: Michael Brodsky
  • Product ID: 705299
  • Duration: 60 Min
This laboratory accreditation training program will focus on technical components of Quality Management System (QMS) including accommodation and environmental conditions, test and calibration methods, equipment, measurement traceability, sampling and much more.
CD/Recorded
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Equal Employment Opportunity (EEO) Beyond the Basics: Key Concepts and Principles

Equal Employment Opportunity (EEO) Beyond the Basics: Key Concepts and Principles

  • Speaker: Mary Gormandy White
  • Product ID: 705483
  • Duration: 60 Min
This webinar will focus on what supervisory and HR professionals at all levels need to know about EEO regulations and requirements, including protected characteristics, workplace harassment, retaliation and more.
CD/Recorded
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HIPAA and BYOD - Portable Devices and Enforcement

HIPAA and BYOD - Portable Devices and Enforcement

  • Speaker: Jim Sheldon-Dean
  • Product ID: 703822
  • Duration: 90 Min
This training session will discuss the requirements, the risks, and the issues of the increasing use of mobile devices for patient communications and provide a road map for how to use them safely and effectively, to increase the quality of health care and patient satisfaction.
CD/Recorded
$249
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Recorded/CD
The Past Isn't in the Past: Effecting Sound Employment Background Checks

The Past Isn't in the Past: Effecting Sound Employment Background Checks

  • Speaker: Jacquiline M Wagner
  • Product ID: 705489
  • Duration: 60 Min
This webinar will discuss the various laws covering background checks, common types, requirements for conducting background checks and more. It will also provide best practices to ensure compliance with the regulatory requirements.
CD/Recorded
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Drug Product Performance, In Vivo: Bioavailability and Bioequivalence

Drug Product Performance, In Vivo: Bioavailability and Bioequivalence

  • Speaker: Leon Shargel
  • Product ID: 705461
  • Duration: 90 Min
This webinar will discuss the basic concepts of bioavailability and bioequivalence and their relationship to drug product performance, in vivo. It will also provide practical examples to show how bioavailability and bioequivalence studies can be applied to drug product development.
CD/Recorded
$249
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Recorded/CD
Good Manufacturing Practices for Active Pharmaceutical Ingredients (APIs)

Good Manufacturing Practices for Active Pharmaceutical Ingredients (APIs)

  • Speaker: Stephanie Cooke
  • Product ID: 705486
  • Duration: 90 Min
This webinar will cover ICH Q7, Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients (API). Attendees will gain a deeper understanding of the importance of GMPs for APIs, apply these principles in their current roles in order to better manage quality, make improvements, solve problems and make decisions.
CD/Recorded
$179
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Recorded/CD
ECCN & CCL - Classification, Exceptions, Documentation, License Requirements & More

ECCN & CCL - Classification, Exceptions, Documentation, License Requirements & More

  • Speaker: Suzanne Bullitt
  • Product ID: 704054
  • Duration: 60 Min
This webcast will provide an overview of U.S. Export Classification Control Numbers (ECCN) and making license determinations via the Commerce Control List (CCL).It will explain the “How to” classification breakdown and the considerations for commodity jurisdictions (CJs).
CD/Recorded
$179
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