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!

The New OSHA Recordkeeping and Reporting Requirements-300, 300A, 301
12
/ Aug
Friday-2022

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.
* Per Attendee
$199
FDA Ambitious Regulation of Social Media and Corporate Responsibility
16
/ Aug
Tuesday-2022

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.
* Per Attendee
$229
Excel Spreadsheets; Ensuring Data Integrity and 21 CFR Part 11 Compliance
23
/ Aug
Tuesday-2022

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
SaaS/Cloud Risk-Based Validation With Time-Saving Templates
13
/ Sep
Tuesday-2022

SaaS/Cloud Risk-Based Validation With Time-Saving Templates

  • 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
Being Prepared for an Active Shooter Incident at Workplace
23
/ Sep
Friday-2022

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.
* Per Attendee
$149
Trial Master File and Clinical Data Management Regulated by FDA
18
/ Oct
Tuesday-2022

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
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
Recorded/CD
Personal and Business Tax Returns Analysis - 1040 Federal Tax Returns, K-1 Forms and Tax Code Updates

Personal and Business Tax Returns Analysis - 1040 Federal Tax Returns, K-1 Forms and Tax Code Updates

  • Speaker: David L Osburn
  • Product ID: 705011
  • Duration: 90 Min
This personal and business tax returns analysis training program will focus on key areas such as 1040 federal tax returns, K-1 forms, and tax code updates and how they affect bank’s clients. It will also discuss the structure of a C corporation, S corporation, and Partnership (including LLC) tax return.
CD/Recorded
$249
Recorded/CD
Performing Effective Management Review of the Quality System

Performing Effective Management Review of the Quality System

  • Speaker: David L Chesney
  • Product ID: 704933
  • Duration: 90 Min
This webinar will teach you how to conduct an effective management review of the quality system which helps you understand how to plan and focus on right metrics and governed by an efficient process. Participants will also understand FDA policy regarding disclosure of management review information during inspections.
CD/Recorded
$249
Recorded/CD
The Physician Advisor's Role in Case Management

The Physician Advisor's Role in Case Management

  • Speaker: Laura Ostrowsky
  • Product ID: 705410
  • Duration: 60 Min
This webinar will focus on regulatory requirements, optimal processes and define the difference in collaboration with both internal and external physician advisor roles. It will also discuss the role of the physician advisor and staffing needs to implement this important role.
CD/Recorded
$249
Recorded/CD
Marketing to Medicare or Medicaid Beneficiaries - What You Can and Cannot Do

Marketing to Medicare or Medicaid Beneficiaries - What You Can and Cannot Do

  • 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.
CD/Recorded
$229
Recorded/CD
How to Prepare a Standard Operating Procedure (SOP)?

How to Prepare a Standard Operating Procedure (SOP)?

  • Speaker: Dr. Afsaneh Motamed Khorasani
  • Product ID: 705131
  • Duration: 60 Min
This webinar will detail a step-by-step procedure on how to write a practical, effective and compliant Standard Operating Procedures (SOPs), review and revise SOPs and maintain compliance over the course of the SOP life-time.
CD/Recorded
$299
Recorded/CD
Tax Evasion and Tax Fraud - What it means to you when monitoring BSA and filing SARs

Tax Evasion and Tax Fraud - What it means to you when monitoring BSA and filing SARs

  • Speaker: Doug Keipper
  • Product ID: 703110
  • Duration: 60 Min
This training on BSA compliance will help you understand the concept of tax evasion and tax fraud and the difference between the two. Learn the best practices to identify tax fraud and how to report suspicious activity.
CD/Recorded
$249
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