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
SOX: Internal Controls for Inventory

SOX: Internal Controls for Inventory

  • Speaker: Mike Morley
  • Product ID: 700359
  • Duration: 60 Min
Effective internal controls keep track of inventory and ensure that its proper value is reflected on the financial statements This presentation will provide you with the tools you need to establish and maintain strong internal controls for Inventory that meet Sarbanes-Oxley standards
CD/Recorded
$199
Recorded/CD
IDE (Investigational Device Exemption) for PMA and 510(k) for CDRH and CBER

IDE (Investigational Device Exemption) for PMA and 510(k) for CDRH and CBER

  • Speaker: E.J Smith
  • Product ID: 700956
  • Duration: 60 Min
This presentation covers all of the steps one should take when beginning the IDE process for a PMA.
CD/Recorded
$249
Recorded/CD
Premarket Approval (PMA) agreement with FDA for the medical device companies - the Requirements

Premarket Approval (PMA) agreement with FDA for the medical device companies - the Requirements

  • Speaker: E.J Smith
  • Product ID: 700955
  • Duration: 60 Min
This class reviews the modular option of filing a PMA and the benefits it offers all companies having to negotiate through the PMA process.
CD/Recorded
$249
Recorded/CD
How to Prepare and Submit a Bullet Proof 510(k) Submission

How to Prepare and Submit a Bullet Proof 510(k) Submission

  • Speaker: David Dills
  • Product ID: 700981
  • Duration: 60 Min
This webinar will provide valuable assistance and guidance to all medical device companies that are preparing and submitting 510(k)s to FDA for review and approval.
CD/Recorded
$249
Recorded/CD
Security Standards ISO 27001 and 27002: What they are and how to use them

Security Standards ISO 27001 and 27002: What they are and how to use them

  • Speaker: Diana Kelley,Ed Moyle
  • Product ID: 700868
  • Duration:
In this webinar, ISO certified lead auditor for 27001, Ed Moyle, and Diana Kelley, Partner at Security Curve, will explain how organizations can use the ISO standards as a baseline for their security and risk management program. This webinar will provide valuable assistance to all companies are building and maintaining information security management systems.
CD/Recorded
$249
Recorded/CD
The Employment Law System and how to stay above the legal line

The Employment Law System and how to stay above the legal line

  • Speaker: Scott Baird
  • Product ID: 700810
  • Duration: 60 Min
In this webinar we will cover the legal principles developed by the common law concerning employee privacy, the major anti-discrimination laws.
CD/Recorded
$149
Recorded/CD
Pharmacovigilance aspects of licensing agreements

Pharmacovigilance aspects of licensing agreements

  • Speaker: Dr.Sidney Kahn
  • Product ID: 700928
  • Duration: 60 Min
Regulatory expectations for reporting in multi-company development and marketing programs.
CD/Recorded
$249
Recorded/CD
Virtualization Compliance Assessment (ESX Server and PCI/DSS 1.1)

Virtualization Compliance Assessment (ESX Server and PCI/DSS 1.1)

  • Speaker: Michael Hoesing
  • Product ID: 700878
  • Duration: 60 Min
In this presentation each on the categories and requirements of the PCI/DSS standard 1.1 will be compared to settings within the Virtualization configuration of a VMware ESX Server 3.x machine. Security professionals who wish to have a closer look at the security settings possible on a virtualization host for consideration when crafting detailed policies.
CD/Recorded
$249
Recorded/CD
Computer System Auditing 21CFR Part 11 Compliance

Computer System Auditing 21CFR Part 11 Compliance

  • Speaker: Richard Poser(PhD)
  • Product ID: 700884
  • Duration: 60 Min
The webinar will address each audit item and train the participants how to determine the compliance status. We will use common examples of non-compliance observations from actual audits and suggest remediation plans that are compliant, efficient and economical.
CD/Recorded
$249
Recorded/CD
Utilizing ICH Guidelines for GCP Regulatory Compliance

Utilizing ICH Guidelines for GCP Regulatory Compliance

  • Speaker: Carl Anderson
  • Product ID: 700855
  • Duration: 60 Min
This presentation reviews key ICH guidelines to directly correlate them with FDA Compliance Program Guidance Manuals that FDA investigators use to conduct GCP inspections. This webinar will provide critical assistance to FDA regulated companies currently conducting or preparing to conduct clinical trials.
CD/Recorded
$299
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
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