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!

Annual Current Good Manufacturing Practices (cGMP) Training
6
/ Dec
Tuesday-2022

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.
* Per Attendee
$199
Data Integrity and Privacy: Compliance with 21 CFR Part 11, SaaS/Cloud, EU GDPR
13
/ Dec
Tuesday-2022

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
Medical Device Change(s) and the 510(k)
17
/ Jan
Tuesday-2023

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performing and documenting meaningful, results driven 510(k) / change analysis activities, based on the FDA's new Draft Guidance, "510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device", dated October 25, 2017.
* Per Attendee
$229
Assaults, Murder - A Major Problem in Healthcare Across the U.S.: What is Your Healthcare Organization Doing to Effectively Prevent & Respond to the Violence?
19
/ Jan
Thursday-2023

Assaults, Murder - A Major Problem in Healthcare Across the U.S.: What is Your Healthcare Organization Doing to Effectively Prevent & Respond to the Violence?

  • 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
$199
Trial Master File and Clinical Data Management Regulated by FDA
27
/ Jan
Friday-2023

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.
* Per Attendee
$199
Excel Spreadsheets; Ensuring Data Integrity and 21 CFR Part 11 Compliance
22
/ Feb
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
Supply Chain and Product Compliance Using RoHS, REACH, and Conflict Minerals
7
/ Mar
Tuesday-2023

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.
* Per Attendee
$199
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
Recorded/CD
Non-Resident Importer in Canada: Responsibilities, Rights, Benefits and More

Non-Resident Importer in Canada: Responsibilities, Rights, Benefits and More

  • Speaker: Fabiola Ferrusquia
  • Product ID: 705463
  • Duration: 60 Min
This webinar will discuss the process of becoming a Canadian Non Resident Importer. Attendees will learn how to attain business registration number, HS tariff classification and tariff treatment, process of claiming GST on imported goods, ways to complete the Canada customs invoice and more.
CD/Recorded
$229
Recorded/CD
Being Prepared for an Active Shooter Incident at Workplace

Being Prepared for an Active Shooter Incident at Workplace

  • Speaker: Michael Aust
  • Product ID: 704652
  • Duration: 60 Min
This training program will take attendees through the actions to take when confronted with an active shooter and in assisting responding law enforcement officials. It will help recognize potential workplace violence indicators and describe actions to take to prevent and explore the General Duty Clause of the OSH Act.
CD/Recorded
$199
Recorded/CD
FDA Ambitious Regulation of Social Media and Corporate Responsibility

FDA Ambitious Regulation of Social Media and Corporate Responsibility

  • Speaker: Casper Uldriks
  • Product ID: 703853
  • Duration: 60 Min
FDA regulates advertising and promotion material as labeling. The legal definition of labeling covers just about anything that explicitly or implicitly conveys a message intended to affect a person’s behavior and decision outcomes. How FDA applies its legal tenants of false and misleading information or variations on that theme requires continual updating by FDA and constant re-evaluation by industry. Now the regulatory landscape involves other federal agencies and academic principles in psychology. It has become very complicated and will prove very costly if you knowingly or unknowing walk into one of FDA’s legal snares. This webinar will bring attendees up to speed so you are clearer about what is a problem, what is not a problem and what becomes a risk laden judgment call.
CD/Recorded
$279
Recorded/CD
The New OSHA Recordkeeping and Reporting Requirements-300, 300A, 301

The New OSHA Recordkeeping and Reporting Requirements-300, 300A, 301

  • Speaker: Michael Aust
  • Product ID: 704465
  • Duration: 60 Min
This webinar training will discuss the recent updates in OSHA Recordkeeping and Reporting Requirements. Speaker will explain the major regulatory changes that went into effect January 1, 2015 Participants will gain valuable understanding of 300, 300A and 301 log, new reporting timeline requirements and exemptions.
CD/Recorded
$249
Recorded/CD
HIPAA Audit and Enforcement Update for 2022 - HHS Keeps Pressure on Access, Privacy, and Security Compliance

HIPAA Audit and Enforcement Update for 2022 - HHS Keeps Pressure on Access, Privacy, and Security Compliance

  • Speaker: Jim Sheldon-Dean
  • Product ID: 705026
  • Duration: 90 Min
This webinar will discuss HIPAA audit and enforcement regulations and processes for 2022 and how they apply to covered entities and business associates. Attendees will learn how to prepare for HIPAA audit to avoid fines and penalties for HIPAA violations.
CD/Recorded
$249
Recorded/CD
Major CGMP Issues - US FDA Concerns in 2022

Major CGMP Issues - US FDA Concerns in 2022

  • Speaker: John E Lincoln
  • Product ID: 702185
  • Duration: 90 Min
This webinar will evaluate the chief areas of FDA CGMP and EU compliance inspections to see actual and anticipated changes in emphasis, and how to better prepare with a company's proactive internal inspection / audit program.
CD/Recorded
$299
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
Recorded/CD
User / Human Factors Engineering Under IEC 62366-1, -2

User / Human Factors Engineering Under IEC 62366-1, -2

  • Speaker: John E Lincoln
  • Product ID: 705111
  • Duration: 90 Min
This webinar will focus on the Key parts of IEC 62366-1:2015 and -2:2016, Human Factors Engineering and Role in Design Control (21 CFR 820.30)l, Design and Development Planning (ISO 13485 7.3) .
CD/Recorded
$299
Recorded/CD
Harmonized Tariff Schedule Classification

Harmonized Tariff Schedule Classification

  • Speaker: Jan Seal
  • Product ID: 705224
  • Duration: 90 Min
In this webinar attendees will understand the rules that are required to classify products in the Harmonized Tariff Schedule. Minimize errors in classification and better prepare your company for import/export audits from the government. It will also assist companies who are eligible for free trade agreements, ex. USMCA, and other agreements, in properly completing Certificates of Origin.
CD/Recorded
$179
Recorded/CD
Challenging the Complexity of Title V Air Permitting: Best Practices

Challenging the Complexity of Title V Air Permitting: Best Practices

  • Speaker: Joe Keenan
  • Product ID: 705189
  • Duration: 90 Min
The webinar will discuss how to evaluate if a Title V Air Permit is required at your facility and how to properly fill them out. After the webinar the attendees will have a good general outline of what is required in a Title V Air Permit, how to go about getting the information to fill it out, and a comprehensive question and answer session.
CD/Recorded
$179
Recorded/CD
Bacterial Endotoxin Test to Include the Latest on Low Endotoxin Recovery (LER)

Bacterial Endotoxin Test to Include the Latest on Low Endotoxin Recovery (LER)

  • Speaker: Barry A Friedman
  • Product ID: 705433
  • Duration: 90 Min
The webinar will review the current testing requirements as defined in the new, revised FDA guidance on Endotoxin and Pyrogen testing. It will further help attendees understand the issues surrounding the Low Endotoxin Recovery (LER) and its regulatory outcome.
CD/Recorded
$299
Recorded/CD
USMCA Rules, Procedures and Documentation

USMCA Rules, Procedures and Documentation

  • Speaker: Jan Seal
  • Product ID: 705498
  • Duration: 90 Min
This webinar will help attendees understand how to meet the rules that are required to qualify their imports/exports between the three USMCA countries (United States, Canada, and Mexico). In addition, this webinar will present some of the major changes between the NAFTA & the USMCA and how these changes may affect the qualification of your products. Some of these changes may impact your company and require advance preparation to meet compliance requirements.
CD/Recorded
$249
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