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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
Creating Effective SOPs for Regulatory Compliance

Creating Effective SOPs for Regulatory Compliance

  • Speaker: Henry Urbach
  • Product ID: 702999
  • Duration: 60 Min
This FDA documentation webinar will explain the regulatory expectations for, and the proper design and maintenance of effective and compliant standard operating procedures (SOPs).
CD/Recorded
$169
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Recorded/CD
Litigation and Bankruptcy : How Accountants Can Help Clients Minimize Attorney Fees

Litigation and Bankruptcy : How Accountants Can Help Clients Minimize Attorney Fees

  • Speaker: Candace Leuck
  • Product ID: 704911
  • Duration: 120 Min
In this webinar, you’ll learn about the role accountants can play in managing litigation and bankruptcy to reduce costs for their clients in cash distressed situations.
CD/Recorded
$0
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Recorded/CD
Payroll Pitfalls-Don't Fall into the Trap for These Five Areas of Payroll

Payroll Pitfalls-Don't Fall into the Trap for These Five Areas of Payroll

  • Speaker: Vicki M. Lambert
  • Product ID: 704871
  • Duration: 90 Min
This webinar training will explain the payroll rules and regulations in today’s world, its complexities and how to understand and detect the compliance and risk requirements to look for. The Instructor will discuss the five biggest payroll pitfalls and how to avoid them.
CD/Recorded
$229
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Recorded/CD
4-hr Virtual Seminar: The Quality Manual Ensuring Regulatory Requirements

4-hr Virtual Seminar: The Quality Manual Ensuring Regulatory Requirements

  • Speaker: Howard Cooper
  • Product ID: 704915
  • Duration: 4 hrs
This 4-hr webinar will focus on product lifecycle concepts that are applicable to all of the FDA regulated industries. Learn the objectives, purpose and scope of the quality manual and how to can be adapted to each different business environment.
CD/Recorded
$0
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Recorded/CD
The FDA Compliance Enforcement Process

The FDA Compliance Enforcement Process

  • Speaker: David L Chesney
  • Product ID: 704913
  • Duration: 90 Min
This 90 mins webinar will provide a thorough understanding of the range of FDA enforcement options and the criteria the agency applies in deciding which to use.
CD/Recorded
$0
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Recorded/CD
Customs Penalties: 19 USC 1592: Avoiding the Impact of a Claim of Commercial Fraud or Negligence

Customs Penalties: 19 USC 1592: Avoiding the Impact of a Claim of Commercial Fraud or Negligence

  • Speaker: Raymond Sullivan
  • Product ID: 704874
  • Duration: 60 Min
This webinar explains custom penalties - 19 USC 1592 and the elements of violations. The instructor will discuss how to respond to a CBP summons, mitigation procedures and customs’ response. Learn about effect of “prior disclosure” and litigation of 19 USC 1592 claims in the Court of International Trade.
CD/Recorded
$0
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Recorded/CD
eLabeling for Medical Devices: Valuable but not easy

eLabeling for Medical Devices: Valuable but not easy

  • Speaker: Daphne Walmer
  • Product ID: 704912
  • Duration: 90 Min
This webinar will explore the benefits of internet-based manuals/IFUs (instructions for use), as well as the products that are eligible to replace paper manuals with internet-based manuals, along with the compliance and business requirements for implementing eLabeling.
CD/Recorded
$249
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Recorded/CD
Auditing Physician Contracts Under the New 2016 Stark Rules

Auditing Physician Contracts Under the New 2016 Stark Rules

  • Speaker: Joseph Wolfe
  • Product ID: 704384
  • Duration: 60 Min
This training program will provide a general Stark Law overview and explain the requirements for compliance with key regulatory exceptions. The program will also summarize the upcoming changes to the Stark Law for 2016.
CD/Recorded
$229
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Recorded/CD
Integrating ISO 14971 Risk Analysis into the Product Development Process

Integrating ISO 14971 Risk Analysis into the Product Development Process

  • Speaker: Russell Pizzuto
  • Product ID: 704926
  • Duration: 90 Min
This Webinar will present the best practices for integrating medical device risk analysis into a quality system. This integrated processes spans new product development, design change, production, and post market surveillance for the lifecycle of the device. Objective evidence produced by the integrated processes can be used to demonstrate risk analysis compliance to 21 CFR 820 and ISO 14971 during an audit.
CD/Recorded
$249
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Recorded/CD
Veterinary Medicine and the DEA Due Diligence Requirement for Dispensing and Prescribing a Controlled Substance

Veterinary Medicine and the DEA Due Diligence Requirement for Dispensing and Prescribing a Controlled Substance

  • Speaker: Carlos M Aquino
  • Product ID: 704892
  • Duration: 60 Min
This webinar will discuss federal laws and regulations covering all veterinarians who dispense and prescribe controlled substances, record-keeping requirements, penalties for non-compliance and the DEA due diligence required.
CD/Recorded
$0
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Recorded/CD
A to Z of Supply Chain Management

A to Z of Supply Chain Management

  • Speaker: Danielle DeLucy
  • Product ID: 704917
  • Duration: 60 Min
This webinar will provide complete view on supply chain management. You will learn how to manage supply chain risk, creating opportunities in an Integrated supply chain, how supply chain decisions impact strategy, how to measure supply chain and vendor success.
CD/Recorded
$0
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Recorded/CD
The New EU Clinical Trial Regulation

The New EU Clinical Trial Regulation

  • Speaker: Robert J Russell
  • Product ID: 703758
  • Duration: 90 Min
This course will present attendees with a clear understanding of the new processes and requirements for EU sponsors of clinical trials as the new regulation is published, rolled-out and implemented by the Member States, the European Medicines Agency and the European Commission.
CD/Recorded
$279
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Recorded/CD
Type 2 DMFs for Active Pharmaceutical Ingredients (APIs)

Type 2 DMFs for Active Pharmaceutical Ingredients (APIs)

  • Speaker: Peggy Berry
  • Product ID: 704882
  • Duration: 90 Min
This webinar will discuss approaches to developing and understanding the manufacturing process for a drug substance. The information obtained will enable completion of the drug substance information in the Drug Master File – in support of Module 3 of a CTD application. The webinar will address aspects of development and manufacture of the drug substance including steps to reduce impurities. Both traditional and enhanced approaches are discussed.
CD/Recorded
$0
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Recorded/CD
How to Use Big Data for an AML/AB&C Compliance and Risk Mitigation

How to Use Big Data for an AML/AB&C Compliance and Risk Mitigation

  • Speaker: Shaun Miller
  • Product ID: 704779
  • Duration: 120 Min
This webinar discuss how big data is used for AML compliance review. The instructor will explain how an unstructured data, becomes structured and is subjected to data quality review, sampling and subsequent forensic analysis. The instructor will share how this analysis influences strategic decision in terms of risk mitigation and AML Program enhancement.
CD/Recorded
$229
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Recorded/CD
USP Hot Topics: What's Hot Now and How to Track Coming Changes and Influence USP

USP Hot Topics: What's Hot Now and How to Track Coming Changes and Influence USP

  • Speaker: Gregory Martin
  • Product ID: 703521
  • Duration: 90 Min
This webinar will provide insight into some of the hottest topics at USP which will have the greatest impact on pharmaceutical laboratories. It will provide a comprehensive overview of the major changes in the USP that have been proposed or implemented in the last year and describe strategies for keeping abreast of coming changes and how you can influence them.
CD/Recorded
$249
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Recorded/CD
Overview of the Mexican Labeling Standards and the New Labeling Requirements

Overview of the Mexican Labeling Standards and the New Labeling Requirements

  • Speaker: Sergio Ernesto Gutierrez
  • Product ID: 704904
  • Duration: 90 Min
In this 90 minutes session, attendees will learn the Mexican labeling standard as well as and the new requirements regarding the use of Front of Pack icons and the voluntary nutritional quality seal.
CD/Recorded
$229
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Recorded/CD
Pre-Demolition Engineering Survey

Pre-Demolition Engineering Survey

  • Speaker: Michael Aust
  • Product ID: 704838
  • Duration: 60 Min
This training program will help you understand OSHA’s requirement for a pre-demolition engineering survey, including what documents to have in place, for renovation and complete demolition of buildings/structures.
CD/Recorded
$299
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Recorded/CD
Customs Valuation and Related Party Transactions - Transfer Pricing Documentation and Obligations

Customs Valuation and Related Party Transactions - Transfer Pricing Documentation and Obligations

  • Speaker: Raymond Sullivan
  • Product ID: 704697
  • Duration: 60 Min
This training program will assist attendees in recognizing related-party valuation issues and discuss documenting the transaction for CBP purposes. It will further help attendees in identifying and documenting transactions that are subject to a transfer pricing agreement.
CD/Recorded
$199
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Recorded/CD
Trans-Pacific Partnership Agreement (TPP)

Trans-Pacific Partnership Agreement (TPP)

  • Speaker: Jan Seal
  • Product ID: 704799
  • Duration: 60 Min
This webinar will provide an introduction into some of the key chapters relating to customs, trade facilitation, duty reductions, and rules of origin and how they could impact your company. Learn more about calculating duty reductions or eliminations, documentation, and certification requirements.
CD/Recorded
$199
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Recorded/CD
Problem Solving using DMAIC

Problem Solving using DMAIC

  • Speaker: Mercedes Massana
  • Product ID: 704807
  • Duration: 60 Min
This webinar will provide an introduction into the DMAIC problem solving process and will show how DMAIC can be utilized to ensure that any process which requires an investigation to be performed can be thoroughly addressed and well documented.
CD/Recorded
$0
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