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
4-Region internal audits: Medical Device Quality System audits that cover internal regulatory compliance for FDA, Europe, Canada and Japan

4-Region internal audits: Medical Device Quality System audits that cover internal regulatory compliance for FDA, Europe, Canada and Japan

  • Speaker: Phil Smart
  • Product ID: 700847
  • Duration: 60 Min
This webinar will provide valuable assistance to all regulated medical device companies who implement internal audit programs to comply with US and international regulations. This presentation will provide an understanding of how to integrate US, Canadian, European and Japanese regulations into an effectively documented and implemented internal audit program.
CD/Recorded
$249
Recorded/CD
Complying with 21CFR Part 11-Understanding the Role of Predicate Rules

Complying with 21CFR Part 11-Understanding the Role of Predicate Rules

  • Speaker: Tony Dunbar
  • Product ID: 700177
  • Duration: 60 Min
AN overview of the Part 11 regulation, with special emphasis on the key role played by the applicable predicate rules as the starting point for any Part 11 compliance assessment. In spite of the FDA’s clarification regarding the scope of electronic records subject to Part 11 as expressed in the Sep 2003 Guidance for Industry, much discussion and debate still surround the topic.
CD/Recorded
$149
Recorded/CD
Preparing Compliant eCTD Submissions

Preparing Compliant eCTD Submissions

  • Speaker: Antoinette Azevedo
  • Product ID: 700719
  • Duration: 60 Min
This webinar will provide valuable assistance to all companies regulated by FDA to understand the current and impending requirements for electronic submissions. The immediate impact is to companies submitting INDs and marketing applications for pharmaceutical and biological products.
CD/Recorded
$249
Recorded/CD
HR Compliance Requirements for small Companies

HR Compliance Requirements for small Companies

  • Speaker: Matthew W Burr
  • Product ID: 700649
  • Duration: 60 Min
This webinar will cover Federal Labor Laws by number of employees and adherence to State Laws.
CD/Recorded
$149
Recorded/CD
Introduction to Defense Trade Controls, ITAR - best-practice strategies to make your program compliant and effective

Introduction to Defense Trade Controls, ITAR - best-practice strategies to make your program compliant and effective

  • Speaker: Natascha Finnerty
  • Product ID: 700696
  • Duration: 60 Min
This presentation will present the major items that your company’s Technology Control Plan and Compliance program must contain. Emphasized are best-practice strategies to make your program compliant and effective.
CD/Recorded
$149
Recorded/CD
The latest approach for complying with 21 CFR Part 11

The latest approach for complying with 21 CFR Part 11

  • Speaker: Sam Mistretta
  • Product ID: 700664
  • Duration: 60 Min
This 21 CFR Part 11 training/webinar will provide valuable assistance to all regulated companies that need to comply with 21 CFR Part 11.
CD/Recorded
$249
Recorded/CD
Overview of the Harmonized Tariff Schedule of the United States - Classifying Your Products for Customs Purposes

Overview of the Harmonized Tariff Schedule of the United States - Classifying Your Products for Customs Purposes

  • Speaker: Paula Connelly
  • Product ID: 700659
  • Duration: 60 Min
This Harmonized Tariff Schedule of the United States training/webinar will provide an overview of the structure of the HTSUS and how to use the HTSUS to determine the correct classification, duty rate, and possible quotas, restrictions or preferential duty rates that may be applicable to your product.
CD/Recorded
$149
Recorded/CD
Sarbanes-Oxley, IT and Segregation of Duties

Sarbanes-Oxley, IT and Segregation of Duties

  • Speaker: George Spafford
  • Product ID: 700112
  • Duration: 60 Min
This segregation of duties (SOD) training/webinar in Sarbanes-Oxley and IT will provide an overview of the current interpretation of Sarbanes-Oxley and will talk about what risks that Sarbanes-Oxley is especially concerned with when it comes to segregation of duties.
CD/Recorded
$99
Recorded/CD
Interviewing and Hiring in Compliance with Federal and State Laws

Interviewing and Hiring in Compliance with Federal and State Laws

  • Speaker: Marna Hayden
  • Product ID: 700647
  • Duration: 60 Min
The HR Compliance training/webinar in Interviewing and Hiring will cover various interviewing techniques and the processes used to make effective selection decisions.
CD/Recorded
$149
Recorded/CD
FDA's cGMPs for the 21st Century Initiative

FDA's cGMPs for the 21st Century Initiative

  • Speaker: Betty Jones
  • Product ID: 700620
  • Duration: 60 Min
This FDA’s cGMPs training/webinar will provide and insider’s view FDA’s path to restructuring its regulatory oversight of manufacturing quality that is based on quality systems and risk management approaches.
CD/Recorded
$249
Recorded/CD
AML requirements for non-bank financial institutions

AML requirements for non-bank financial institutions

  • Speaker: Kenneth Barden
  • Product ID: 700483
  • Duration: 60 Min
This webinar will focus on AML issues relevant to non-bank financial institutions, such as insurance companies, capital market intermediaries, pension funds, etc.
CD/Recorded
$149
Recorded/CD
Part 11 - Electronic Records and Electronic Signatures

Part 11 - Electronic Records and Electronic Signatures

  • Speaker: Betty Jones
  • Product ID: 700619
  • Duration: 60 Min
This Part 11 - Electronic Records webinar will provide an insider’s view FDA’s current thinking regarding the scope and application of Part 11 of Title 21 of the Code of Federal Regulations; Electronic Records; Electronic Signatures (21 CFR Part 11).
CD/Recorded
$249
Recorded/CD
Doing Business under the North American Free Trade Agreement, Understanding NAFTA

Doing Business under the North American Free Trade Agreement, Understanding NAFTA

  • Speaker: David Ross
  • Product ID: 700496
  • Duration: 60 Min
This NAFTA webinar/training is designed for middle and upper management to help them understand these complex rules to avoid costly fines and penalties and delays in moving their products within North America.
CD/Recorded
$149
Recorded/CD
Global Terms of Sale: Understanding Incoterms 2000

Global Terms of Sale: Understanding Incoterms 2000

  • Speaker: David Ross
  • Product ID: 700495
  • Duration: 60 Min
This module is designed for middle and upper management to help them understand the complexities and the financial impact on their international business
CD/Recorded
$149
Recorded/CD
The In's and Out's of FLSA: Fair Labor Standards Act

The In's and Out's of FLSA: Fair Labor Standards Act

  • Speaker: Jarik E Conrad
  • Product ID: 700545
  • Duration: 60 Min
This workshop will provide an overview of FLSA and its four provisions: (1) Minimum wage; (2) Hours of work; (3) Child labor; and (4) Equal pay
CD/Recorded
$149
Recorded/CD
New SEC Guidance on Sarbanes-Oxley Section 404

New SEC Guidance on Sarbanes-Oxley Section 404

  • Speaker: Bob Benoit
  • Product ID: 700538
  • Duration: 60 Min
This Sarbanes-Oxley Section 404 compliance training will discussed recent developments in the SEC guidance.
CD/Recorded
$149
Recorded/CD
Applying HACCP to insure compliance

Applying HACCP to insure compliance

  • Speaker: Joyce Wilkins
  • Product ID: 700466
  • Duration: 60 Min
This HACCP training will equip the student to apply the concepts of HACCP in their food operation in a manner that is useful and effective without being unduly burdensome. Although HACCP has been around for over 40 years, it still remains the standard in designing a food safety program.
CD/Recorded
$149
Recorded/CD
C-TPAT - Standard Operating Procedures for Security in the Supply Chain

C-TPAT - Standard Operating Procedures for Security in the Supply Chain

  • Speaker: Karma Ruiz,Charlie Hocker
  • Product ID: 700488
  • Duration: 60 Min
In this C-TPAT training we will walk you through the most effective processes we have developed and how they can be customized for your company.
CD/Recorded
$149
Recorded/CD
C-TPAT - annual training for employees to fulfill C-TPAT requirements by CBP

C-TPAT - annual training for employees to fulfill C-TPAT requirements by CBP

  • Speaker: Karma Ruiz,Charlie Hocker
  • Product ID: 700487
  • Duration: 60 Min
This C-TPAT training will guide you on the annual training for employees to fulfill C-TPAT requirements by CBP.
CD/Recorded
$149
Recorded/CD
Processes for 510(k) Clearances for In Vitro Diagnostic/IVD Device Products via FDA-CDRH

Processes for 510(k) Clearances for In Vitro Diagnostic/IVD Device Products via FDA-CDRH

  • Speaker: Alfredo J Quattrone
  • Product ID: 700442
  • Duration: 60 Min
This 510(k) Clearances training/webinar will provide valuable assistance to all regulated companies that need to validate their systems.
CD/Recorded
$149
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