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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
Regulatory requirements on pharmaceutical packaging materials from US and EU points of view

Regulatory requirements on pharmaceutical packaging materials from US and EU points of view

  • Speaker: Paul Chen
  • Product ID: 701106
  • Duration: 90 Min
This pharmaceutical training provides a detail review and evaluation of Regulatory requirements on pharmaceutical packaging materials from US and EU. This pharmaceutical training provides a detail review and evaluation of the regulatory requirements for packaging operations including description, suitability, protection, safety, compatibility, performance, Quality Control, supplier, and stability.
CD/Recorded
$0
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Recorded/CD
510(k) Applications made Simple

510(k) Applications made Simple

  • Speaker: E.J Smith
  • Product ID: 701082
  • Duration: 60 Min
This 510(k) Training covers the content requirements of a traditional 510(k) application and covers in detail the recommended 20 sections. This 510(k) Training deals only with those medical devices that require a 510(k) application. All Manufacturers introducing Class II medical devices to the US market must submit a FDA 510(k). It is also required for manufacturers that are changing the intended use of the medical device, or changing the technology of a cleared device such a way that it may significantly affect its safety or effectiveness.
CD/Recorded
$299
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Recorded/CD
Changes to the Medical Devices Directive: 93/42/EEC

Changes to the Medical Devices Directive: 93/42/EEC

  • Speaker: David Dills
  • Product ID: 701073
  • Duration: 60 Min
This webinar will provide valuable assistance and guidance to medical device companies that are preparing for CE Mark and ensuring compliance to MDD 93/42/EEC.
CD/Recorded
$299
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Recorded/CD
The IDE (Investigational Device Exemption) - It's Purpose and Preparation

The IDE (Investigational Device Exemption) - It's Purpose and Preparation

  • Speaker: John E Lincoln
  • Product ID: 701087
  • Duration: 60 Min
This IDE (Investigational Device Exemption) webinar will cover its purpose and preparation recommended subject headings and content Submission and follow up Usage in the clinical trial(s).
CD/Recorded
$299
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Recorded/CD
Japan PAL Audits performed abroad by the PMDA: What to expect and how to prepare

Japan PAL Audits performed abroad by the PMDA: What to expect and how to prepare

  • Speaker: Phil Smart
  • Product ID: 701049
  • Duration: 90 Min
This training course will concentrate on how to prepare for the audit, from language and culture to technical requirements and auditor expectations. Due to the 2005 revisions in the Japanese Pharmaceutical Affairs Law (PAL), the PMDA - Pharmaceuticals and Medical Devices Agency - is beginning to step up its scheduling of on-site audits of foreign medical device manufacturers.
CD/Recorded
$249
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Recorded/CD
Accounts Receivables: How to Ensure Sarbanes-Oxley Compliance

Accounts Receivables: How to Ensure Sarbanes-Oxley Compliance

  • Speaker: Mike Morley
  • Product ID: 700185
  • Duration: 60 Min
What credit professionals need to understand to carry out their responsibilities and duties to ensure Sarbanes-Oxley compliance. The Sarbanes-Oxley Act of 2002 makes company executives of publicly traded US companies personally and criminally responsible for the accuracy and reliability of the financial disclosures of their companies.
CD/Recorded
$199
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Recorded/CD
Complying with Sarbanes Oxley (SOX), Section 404

Complying with Sarbanes Oxley (SOX), Section 404

  • Speaker: Bernice Russell Bond
  • Product ID: 700944
  • Duration: 90 Min
Learn how to comply Sarbanes Oxley compliance in a cost-efficient manner. Many have questioned whether the Sarbanes-Oxley law requirements can be met in a cost-efficient manner. Absorbing the first-year lessons — and, going forward, is a challenge facing all public companies as they prepare to meet quarterly and annual reporting requirements. And further challenges will arise as new compliance issues emerge and PCAOB regulations evolve.
CD/Recorded
$249
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Recorded/CD
How to implement a sustainable Information Security Management System (ISMS)

How to implement a sustainable Information Security Management System (ISMS)

  • Speaker: George Spafford
  • Product ID: 700948
  • Duration: 60 Min
This presentation will review the ISMS and architectural considerations that need to be addressed. An ISMS can help an organization effectively and efficiently manage information security related risks.
CD/Recorded
$249
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Recorded/CD
Internal Control and Sarbanes-Oxley Section 404

Internal Control and Sarbanes-Oxley Section 404

  • Speaker: Dr. Sandford Liebesman
  • Product ID: 700936
  • Duration:
The core of the presentation will be an in-depth look at Section 404 and the COSO Guidance used by most organizations for compliance. We will describe the SOX legislation including the creation of the Public Corporation Accounting Oversight Board (PCAOB) and key sections of the Act.
CD/Recorded
$149
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Recorded/CD
Leveraging SOX Anti-Fraud Programs to Reduce Company-Wide Risks

Leveraging SOX Anti-Fraud Programs to Reduce Company-Wide Risks

  • Speaker: Peter Goldmann
  • Product ID: 700938
  • Duration: 60 Min
The training supports SOX Compliance (particularly Section 30 as it pertains to anonymous hotlines), and conforms to key criteria of the revised US Federal Sentencing Guidelines. Know how to promptly and effectively REPORT incidents of fraud or suspicious conduct.
CD/Recorded
$199
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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