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
Dealing with and Preventing Leave Abuse under FMLA, ADA and Workers' Comp

Dealing with and Preventing Leave Abuse under FMLA, ADA and Workers' Comp

  • Speaker: Janette Levey Frisch
  • Product ID: 704368
  • Duration: 120 Min
This webinar will help you get a working knowledge of how you can minimize your company’s exposure to employee abuse of family and medical leave – be it under the FMLA, ADA, or workers’ comp or other applicable family and medical leave laws.
CD/Recorded
$249
Recorded/CD
Steam Sterilization Microbiology and Autoclave Performance Qualification

Steam Sterilization Microbiology and Autoclave Performance Qualification

  • Speaker: Danielle DeLucy
  • Product ID: 705027
  • Duration: 60 Min
In this webinar, the steam sterilization mechanism will be described as it relates to bacterial cells and endospores. The process and key terminology are defined. Understanding these fundamentals is critical to develop a successful autoclave sterilization process.
CD/Recorded
$299
Recorded/CD
Is HR Placing Your Organization at Risk: Hiring Contract Employees?

Is HR Placing Your Organization at Risk: Hiring Contract Employees?

  • Speaker: Michael Aust
  • Product ID: 704909
  • Duration: 60 Min
You will want to participate in this webinar to gain insight on how to protect your employer from OSHA regulation as well as to develop an understanding on OSHA’s stance for contract and temporary workers. Also, you will not want to miss out on the discussion of the National Labor Relations Board (NLRB) recent stance on the issue.
CD/Recorded
$229
Recorded/CD
The U.S. Food and Drug Administration’s Regulation of Pet Food: Complying with FDA’s Rules for the Marketing and Sale of Dog and Cat Food

The U.S. Food and Drug Administration’s Regulation of Pet Food: Complying with FDA’s Rules for the Marketing and Sale of Dog and Cat Food

  • Speaker: Karl M. Nobert
  • Product ID: 702224
  • Duration: 90 Min
This webinar will provide an introduction to FDA rules governing manufacturing, testing, labeling and marketing of pet food in the U.S. In addition to facility inspections and product recalls, the webinar will summarize and assess FDA’s enforcement activity in the U.S. pet food market paying particular attention to enforcement trends and risks.
CD/Recorded
$399
Recorded/CD
ICD-10-CM 101, the A, B, Cs and 1, 2, 3s

ICD-10-CM 101, the A, B, Cs and 1, 2, 3s

  • Speaker: Victoria M Hernandez
  • Product ID: 703016
  • Duration: 60 Min
This healthcare coding webinar will provide an overview of ICD-10-CM, the format and guidelines. It will also explain the differences between ICD-9 and ICD-10 to help you understand how it will affect your work and as well as your co-workers and providers.
CD/Recorded
$299
Recorded/CD
Unemployment Insurance: Critical Issues in 2021

Unemployment Insurance: Critical Issues in 2021

  • Speaker: Ronald Adler
  • Product ID: 703880
  • Duration: 90 Min
The webinar will provide an update of key federal and state unemployment issues. Participants will gain an understanding of the critical issues affecting their individual Unemployment Insurance (UI) accounts and develop methods to control UI costs and manage other related liabilities.
CD/Recorded
$349
Recorded/CD
Veterinary Medical Devices and FDA’s Regulatory Oversight

Veterinary Medical Devices and FDA’s Regulatory Oversight

  • Speaker: Karl M. Nobert
  • Product ID: 703769
  • Duration: 60 Min
This webinar will make your understand regulatory requirements of veterinary medical device. How to differentiate regulations of human and veterinary medical devices, manufacturing requirements, safety standards, labelling requirements, how to draft the SOPs covering material intake, production, quality control, packing, distribution and sales.
CD/Recorded
$179
Recorded/CD
Service Level Agreements (SLAs) - Preparation Guidelines for Effective SLAs

Service Level Agreements (SLAs) - Preparation Guidelines for Effective SLAs

  • Speaker: Javier Kuong
  • Product ID: 700485
  • Duration: 120 Min
This 2-hr webinar on Service Level Agreements (SLAs) will provide you with sound principles and a set of guidelines for developing and preparing ‘effective’ Service Level Agreements (SLAs) for an internal service function or an outside service provider.
CD/Recorded
$229
Recorded/CD
Mission Possible: How to Obtain A Zero Injury Culture In The Workplace

Mission Possible: How to Obtain A Zero Injury Culture In The Workplace

  • Speaker: Michael Aust
  • Product ID: 704739
  • Duration: 60 Min
This zero tolerance for injuries training program will discuss what it means to have a safety culture on site. It will also identify the four steps of the safety maturity curve and discuss employee and employer rights and responsibilities at each step of the maturity curve. The instructor will explain the benefits of sustaining a safety culture in the workplace.
CD/Recorded
$299
Recorded/CD
HR Audits: Identifying and Managing What Happens Next as the Result of Pandemic

HR Audits: Identifying and Managing What Happens Next as the Result of Pandemic

  • Speaker: Ronald Adler
  • Product ID: 703882
  • Duration: 90 Min
This HR Audit webinar will cover key strategic, operational, and compliance HR management issues. The objective is to provide the attendee with the key areas that should be addressed in conducting an HR audit, an understanding of critical tasks to be completed, and an update how federal and state employment laws may affect the scope and the reporting of the HR audit.
CD/Recorded
$249
Recorded/CD
An Introduction to FDA's Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (''HCT/Ps'') including Stem Cell-Based Drug Products for Human Use

An Introduction to FDA's Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (''HCT/Ps'') including Stem Cell-Based Drug Products for Human Use

  • Speaker: Karl M. Nobert
  • Product ID: 701927
  • Duration: 90 Min
This webinar will review FDA's regulatory oversight of stem cell-based products when used in humans and analyze its potential impact on the industry in the future. Learn FDA's criteria for marketing and promotion of stem cell-based products for therapeutic application.
CD/Recorded
$399
Recorded/CD
Employee Handbooks:  Key issues Post Pandemic

Employee Handbooks: Key issues Post Pandemic

  • Speaker: Ronald Adler
  • Product ID: 703910
  • Duration: 90 Min
This webinar discusses the key employment policies that should be incorporated in every employee handbook. The webinar further identifies policies statements that add value to the employer-employee relationship and discusses key issues that will require inclusion in the future.
CD/Recorded
$249
Recorded/CD
Implementation and Management of GMP Data Integrity

Implementation and Management of GMP Data Integrity

  • Speaker: Danielle DeLucy
  • Product ID: 705029
  • Duration: 90 Min
Attend this webinar to learn the regulatory expectations for data integrity during CGMP inspections. The course will review examples of data integrity pitfalls, part 11 compliance data integrity issues, FDA citations related to data integrity. It will teach you how to improve data integrity in a laboratory environment.
CD/Recorded
$299
Recorded/CD
Pricing Contractor Jobsite Overhead Delay Costs

Pricing Contractor Jobsite Overhead Delay Costs

  • Speaker: Jim Zack
  • Product ID: 704367
  • Duration: 90 Min
After attending this training program, attendees will have a better understanding of the issues concerning the pricing of contractor delay damages. Contractors will gain knowledge about the various methods of calculating extended field office overhead costs. Owners will learn some contractual methods for predetermining this element of delay costs in order to prevent the need for end of the job audits or disputes over such costs.
CD/Recorded
$229
Recorded/CD
Tattoos, Sandals, Yarmulkes, Dress and Appearance:  Increasing Legal Challenges for Employees and Employers

Tattoos, Sandals, Yarmulkes, Dress and Appearance: Increasing Legal Challenges for Employees and Employers

  • Speaker: Dr. Susan Strauss
  • Product ID: 704557
  • Duration: 60 Min
This webinar training will explain the role of HR professionals and managers in implementing discrimination-free dress code to ensure all job candidates and employees are treated fairly and equitably. Dress codes are receiving a fair amount of attention in the courts these days with number of precedent setting lawsuits dealing with dress codes’ requirements. The instructor will explain how your current dress code can discriminate against potential and current employees based on their gender, religion, and race, to name a few and lead to lawsuits.
CD/Recorded
$229
Recorded/CD
Introduction to Root Cause Investigation for CAPA

Introduction to Root Cause Investigation for CAPA

  • Speaker: Vanessa Lopez
  • Product ID: 704409
  • Duration: 60 Min
This CAPA training program will provide an understanding of FDA and ISO requirements, steps in CAPA process and the challenges associated to root cause analysis. Attendees will learn the tools and quality data sources to use during root cause analysis investigation.
CD/Recorded
$199
Recorded/CD
Supplier and Service Provider Controls: FDA Expectations

Supplier and Service Provider Controls: FDA Expectations

  • Speaker: Vanessa Lopez
  • Product ID: 704844
  • Duration: 120 Min
This training program will provide regulatory requirements (US) of 21 CFR Section 820.50 (purchasing control) for the medical device industry and illustrate the same with examples. It will furnish details on what purchasing/supplier control management systems should address.
CD/Recorded
$349
Recorded/CD
Best Practices for Setting Up a Global International Trade Compliance Program

Best Practices for Setting Up a Global International Trade Compliance Program

  • Speaker: Deep SenGupta
  • Product ID: 703708
  • Duration: 60 Min
Attend this webinar to learn how to evaluate the trade compliance risk for your worldwide subsidiaries and how to ensure that your worldwide subsidiaries are adequately managing their trade compliance risk.
CD/Recorded
$349
Recorded/CD
Import and Export - Improving Your International Trade Compliance Score

Import and Export - Improving Your International Trade Compliance Score

  • Speaker: Deep SenGupta
  • Product ID: 703961
  • Duration: 60 Min
This international trade compliance training program will evaluate strategies such as drawback, foreign trade zones or free trade agreements. It will also offer guidance and best practice strategies for several import/export practices such as methodology for measuring trade compliance score, and determining export control classification number.
CD/Recorded
$349
Recorded/CD
Successful 510(k) Submissions

Successful 510(k) Submissions

  • Speaker: John E Lincoln
  • Product ID: 700815
  • Duration: 60 Min
In this 510(k) submission process webinar attendees will learn the different types of 510(k)s, 21 required elements in the traditional 510(k) and how are they addressed and documented. Also attendees will learn software / firmware requirements, De Novo submission for obtaining marketing clearance for medical devices in the U.S.
CD/Recorded
$399
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