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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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Excel Spreadsheets; Ensuring Data Integrity and 21 CFR Part 11 Compliance
13
/ Dec
Wednesday-2023

Excel Spreadsheets; Ensuring Data Integrity and 21 CFR Part 11 Compliance

  • Speaker: David Nettleton
  • Product ID: 701582
  • Duration: 75 Min
Learn how to use Microsoft Excel spreadsheets for GXP data to ensure compliance with 21 CFR Part 11 and reduce validation cost and time.
* Per Attendee
$229
View Details
Legal & Ethical Challenges for Employers: An Increase In Burnout, Stress, & Mental Illness
12
/ Jan
Friday-2024

Legal & Ethical Challenges for Employers: An Increase In Burnout, Stress, & Mental Illness

  • Speaker: Dr. Susan Strauss
  • Product ID: 706946
  • Duration: 90 Min
Employers are seeing more mental health issues in their workforce than ever before. Long COVID has enhanced mental health concerns even more. Each year 1 in 5 adults is stricken with a mental illness (National Institute of Mental health), making mental illness an everyday reality for many of your employees. Yet only 1 in 3 people seek help with their illness. The ADA, HIPPA, FMLA and most states’ human/civil rights department dictate how employers deal with employees with mental health problems and could charge employers with civil rights liability. Privacy laws create challenges for employers to determine how serious a situation is and whether an employee poses a danger (though those with a mental illness pose no more risk of violence than those without a mental illness). Two thirds of employees would take a pay cut for a job that supports mental health – do you? As a manager, what can you do to better recognize and take care of your employees’ mental health? Seventy percent of employees could do more to support their employees’ mental health according to the Society of Human Rights Management (SHRM, February 15, 2023).
* Per Attendee
$199
View Details
Care of the LGBT Patient and Their Families: Policies, Procedures & Practices to Ensure Quality Care and Reduce Liability
23
/ Jan
Tuesday-2024

Care of the LGBT Patient and Their Families: Policies, Procedures & Practices to Ensure Quality Care and Reduce Liability

  • Speaker: Dr. Susan Strauss
  • Product ID: 704699
  • Duration: 75 Min
This training program will list and enumerate relevant laws, regulations and standards required for health equity and patient-centered care of LGBT patients. It will discuss opportunities to collect LGBT–relevant data and information during the healthcare encounter and help chart strategic community outreach efforts to the LGBT population.
* Per Attendee
$199
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Data Integrity and Privacy: Compliance with 21 CFR Part 11, SaaS/Cloud, EU GDPR
6
/ Feb
Tuesday-2024

Data Integrity and Privacy: Compliance with 21 CFR Part 11, SaaS/Cloud, EU GDPR

  • Speaker: David Nettleton
  • Product ID: 701687
  • Duration: 90 Min
This 21 CFR Part 11 compliance training will guide you through the requirements of Part 11 and will also explain its 3 primary areas: SOPs, product features and validation (10 step risk based approach).
* Per Attendee
$249
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Workplace Unconscious Bias: Minimizing the Impact on Discrimination, Hiring, Promotions, and Retention
13
/ Feb
Tuesday-2024

Workplace Unconscious Bias: Minimizing the Impact on Discrimination, Hiring, Promotions, and Retention

  • Speaker: Dr. Susan Strauss
  • Product ID: 704876
  • Duration: 60 Min
Unconscious bias has been recognized as a form of discrimination and can therefore lead to lawsuits. This training program addresses the science of unconscious bias and lists the examples and types. The Instructor will discuss the implicit association test (IAT) and steps to minimize individual and organizational unconscious bias in hiring, promotions, and retention.
* Per Attendee
$199
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Mastering Medicare and Medicaid Marketing Regulations: Do's and Don'ts
16
/ Feb
Friday-2024

Mastering Medicare and Medicaid Marketing Regulations: Do's and Don'ts

  • Speaker: William Mack Copeland
  • Product ID: 705230
  • Duration: 60 Min
This webinar will review not only the Anti-Kickback Statute and its safe harbors, but will provide an in-depth overview of OIG guidance and advisory opinions dealing with marketing activities, as well as a review of case law regarding marketing behavior.
* Per Attendee
$199
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The Complexity and Interplay Among ADAAA, FMLA, and Worker's Comp (WC) - How Do They Work Together, or Not?
7
/ Mar
Thursday-2024

The Complexity and Interplay Among ADAAA, FMLA, and Worker's Comp (WC) - How Do They Work Together, or Not?

  • Speaker: Dr. Susan Strauss
  • Product ID: 704959
  • Duration: 90 Min
The webinar training will address ADAAA, FMLA, and Worker’s Comp laws that HR is responsible for upholding. When the laws are not followed, it increases the liability for the organization and interferes with a fair and equitable work environment for employees.
* Per Attendee
$199
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The Unthinkable: Violence in Healthcare from Bullying to an Active Shooter
28
/ Mar
Thursday-2024

The Unthinkable: Violence in Healthcare from Bullying to an Active Shooter

  • Speaker: Dr. Susan Strauss
  • Product ID: 704727
  • Duration: 120 Min
The healthcare environment creates a major challenge in the prevention and intervention of violence. The rate of injuries and illness from violence in the healthcare industry is more than three times greater than violence in all private industry. This training program will explore what makes violence in healthcare unique and its negative ramifications on quality patient care.
* Per Attendee
$229
View Details
Recorded/CD
Storm Water Pollution Prevention Plans (SWPPP)

Storm Water Pollution Prevention Plans (SWPPP)

  • Speaker: Joe Keenan
  • Product ID: 705510
  • Duration: 90 Min
This webinar will discuss the basics of what is required in a Storm Water Pollution Prevention Plan (SWPPP), how to develop and implement and formalized SWPPP and address site-specific questions and scenarios.
CD/Recorded
$249
View Details
Recorded/CD
Supply Chain and Product Compliance Using RoHS, REACH, and Conflict Minerals

Supply Chain and Product Compliance Using RoHS, REACH, and Conflict Minerals

  • Speaker: Kelly Eisenhardt
  • Product ID: 703871
  • Duration: 60 Min
This training program will offer an in-depth look at three important product regulations focused on materials compliance and ethical sourcing, along with the tools and policies needed to implement them.
CD/Recorded
$249
View Details
Recorded/CD
Total Organic Carbon Analysis for Cleaning Validation in Pharmaceutical Manufacturing

Total Organic Carbon Analysis for Cleaning Validation in Pharmaceutical Manufacturing

  • Speaker: Joy McElroy
  • Product ID: 705929
  • Duration: 90 Min
In this cleaning validation webinar attendees will learn the Total Organic Carbon (TOC) feasibility, method validation and transfer from the laboratory to the manufacturing floor, as well as reviewing a feasibility study of multiple, difficult to oxidise or low solubility organic compounds.
CD/Recorded
$299
View Details
Recorded/CD
Effective Systems for Change Control in the Pharmaceutical Industry

Effective Systems for Change Control in the Pharmaceutical Industry

  • Speaker: David L Chesney
  • Product ID: 705002
  • Duration: 90 Min
This webinar will help you understand GMP requirements for change control from a pharmaceutical manufacturing perspective, the purpose of change control and what types of changes are or are not subject to change control. Participants will learn how to execute and implement a change in a regulated environment.
CD/Recorded
$249
View Details
Recorded/CD
Advanced Auditing for Data Integrity

Advanced Auditing for Data Integrity

  • Speaker: Joy McElroy
  • Product ID: 705275
  • Duration: 90 Min
This training program will teach attendees best practices on how to perform audits for data integrity within their organization. Attendees will also learn how to centralize management and eliminate silos.
CD/Recorded
$249
View Details
Recorded/CD
How To Create an Effective Export Control Compliance Program under the Export Administration Regulations in 2023

How To Create an Effective Export Control Compliance Program under the Export Administration Regulations in 2023

  • Speaker: Douglas Cohen
  • Product ID: 703983
  • Duration: 60 Min
This training program will assist attendees in establishing and enhancing an export compliance program and offer best practices for export compliance given under the Export Administration Regulations (EARs).
CD/Recorded
$149
View Details
Recorded/CD
Writing an Effective SAR Narrative

Writing an Effective SAR Narrative

  • Speaker: Doug Keipper
  • Product ID: 702993
  • Duration: 60 Min
This BSA compliance training on Suspicious Activity Reporting (SAR) will provide details on how to prepare a SAR (Suspicious Activity Reporting) narrative that meets examiner scrutiny and provides necessary detail for law enforcement.
CD/Recorded
$199
View Details
Recorded/CD
Computer System Validation and Part 11 Compliance

Computer System Validation and Part 11 Compliance

  • Speaker: Joy McElroy
  • Product ID: 705427
  • Duration: 60 Min
This webinar will discuss in detail the requirements of 21 CFR part 11 and updated European Annex 11 regulation including requirements for local, SaaS, and cloud hosting. It will also offer techniques to implement a computer system using risk-based validation to gain maximum productivity and reduce cost by as much as two thirds.
CD/Recorded
$249
View Details
Recorded/CD
Trial Master File and Clinical Data Management Regulated by FDA

Trial Master File and Clinical Data Management Regulated by FDA

  • Speaker: Carolyn Troiano
  • Product ID: 705360
  • Duration: 60 Min
This FDA compliance training will cover in detail the new requirements for trial master files including documents related to clinical trials that are required to be prepared, collected and maintained as part of the TMF.
CD/Recorded
$249
View Details
Recorded/CD
Medical Device Change(s) and the 510(k)

Medical Device Change(s) and the 510(k)

  • Speaker: John E Lincoln
  • Product ID: 701742
  • Duration: 90 Min
This 90-minute webinar will provide valuable assistance to all regulated companies performing and documenting meaningful, results driven 510(k) / change analysis activities, based on the FDA's new Draft Guidance, "510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device", dated October 25, 2017.
CD/Recorded
$299
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Recorded/CD
Annual Current Good Manufacturing Practices (cGMP) Training

Annual Current Good Manufacturing Practices (cGMP) Training

  • Speaker: Kelly Thomas
  • Product ID: 705422
  • Duration: 60 Min
This webinar provides a basic understanding and fundamental principles of Current Good Manufacturing Practices and will fulfill the requirement of personnel involved in cGMP must have documented training of current Good Manufacturing Practices. This session will focus on the FDC Act and 21 CFR federal regulations as applied to cGMP.
CD/Recorded
$249
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Recorded/CD
Human Factors/Usability Studies following ISO 62366 and the new FDA Guidance

Human Factors/Usability Studies following ISO 62366 and the new FDA Guidance

  • Speaker: Edwin Waldbusser
  • Product ID: 704496
  • 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
View Details
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