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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
Control Activities Component of COSO at the Entity Level

Control Activities Component of COSO at the Entity Level

  • Speaker: John C Blackshire
  • Product ID: 700974
  • Duration: 90 Min
This COSO training will provide an in depth look at the Control Activities Component of COSO at the Entity Level. The goals of these principles within this Component are to allow for the Key Controls at various layers and levels within ICFR to reduce risks of achievement of financial reporting objectives.
CD/Recorded
$299
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Recorded/CD
Japanese PAL - Dealing with a JPAL Quality Interface Agreement between the foreign manufacturer and MAH (Marketing Authorization Holder)

Japanese PAL - Dealing with a JPAL Quality Interface Agreement between the foreign manufacturer and MAH (Marketing Authorization Holder)

  • Speaker: Phil Smart
  • Product ID: 701277
  • Duration: 90 Min
This JPAL training will describe requirements, common mistakes & best practices while dealing with a JPAL Quality Interface Agreement between the foreign manufacturer and MAH (Marketing Authorization Holder).
CD/Recorded
$299
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Recorded/CD
Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences PART I

Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences PART I

  • Speaker: Robert J Russell
  • Product ID: 701258
  • Duration: 90 Min
This Regulatory compliance training is designed to provide an overview of the regulatory environment in Japan.
CD/Recorded
$299
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Recorded/CD
Japanese PAL - Navigating the Japanese Pharmaceutical Affairs Law

Japanese PAL - Navigating the Japanese Pharmaceutical Affairs Law

  • Speaker: Phil Smart
  • Product ID: 701276
  • Duration: 90 Min
This JPAL training will emphasize on Japanese Pharmaceutical Affairs law with respect to - Classification, device approvals, clinical data, MAH (Marketing Authorization Holder),foreign manufacturer accreditation,QMS,post-market complaints & vigilance
CD/Recorded
$299
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Recorded/CD
HACCP in a Real World Environment

HACCP in a Real World Environment

  • Speaker: John Miller
  • Product ID: 701173
  • Duration: 60 Min
This HACCP training will explain the FSIS regulations and policies program requirements.
CD/Recorded
$50
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Recorded/CD
Delivering Biopharmaceutical Facilities in a Risk Based World: The Role of GEP, QbD, and E2500

Delivering Biopharmaceutical Facilities in a Risk Based World: The Role of GEP, QbD, and E2500

  • Speaker: Jeff Odum
  • Product ID: 701207
  • Duration: 60 Min
This Biopharmaceutical training will introduce and link the concepts of GEP and QbD and also identify synergies with the new ASTM E2500 standard Biopharmaceutical Active Pharmaceutical Ingredients (APIs) must be produced according to Good Manufacturing Practices outlined in FDA and ICH guidelines in order to be marketed to the public. This webinar will review the areas that an inspector may examine when conducting an audit of a biopharmaceutical API supplier to ensure it complies with regulatory requirements.
CD/Recorded
$129
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Recorded/CD
Risk Evaluation and Mitigation Strategies (REMS) what you need to know in order to comply with FDA's new requirements

Risk Evaluation and Mitigation Strategies (REMS) what you need to know in order to comply with FDA's new requirements

  • Speaker: R. Wayne Frost
  • Product ID: 701155
  • Duration: 60 Min
This FDA compliance training will be valuable who are involved in the development of REMS and who are planning a submission and need to understand what might be required by FDA and how to comply and for those who have Risk Management Plans.
CD/Recorded
$299
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Recorded/CD
Rules of Practice (FSIS) 9CFR part 500

Rules of Practice (FSIS) 9CFR part 500

  • Speaker: John Miller
  • Product ID: 701172
  • Duration:
This Food Safety and Inspection Service (FSIS) training will guide you through the different levels of enforcement that FSIS utilizes.
CD/Recorded
$199
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Recorded/CD
21 CFR Part 11 compliance under the Obama administration

21 CFR Part 11 compliance under the Obama administration

  • Speaker: Alfonso Fuller
  • Product ID: 701215
  • Duration: 60 Min
This 21 CFR Part 11 training will deliver concrete guidance which will provide a roadmap for compliance that will have immediate benefits, withstand FDA’s changes to Part 11, and discuss the new Obama administration approach to enforcement.
CD/Recorded
$299
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Recorded/CD
Critical Control Points (CCP’s). Where are they? Why? When?

Critical Control Points (CCP’s). Where are they? Why? When?

  • Speaker: Irwin Pronk
  • Product ID: 701180
  • Duration: 60 Min
This Food safety compliance training will explain the CCP Decision Tree and help you understand the principles behind each question. We will review various food processing steps in a variety of situations to determine whether they are CCP’s. What is the thought process in determining a CCP? Can it be done consistently? What criteria are used? Are some processing steps always CCP's e.g. heating? If not, why? One thing to remember is the importance of analyzing the hazards at each step very carefully. The more clearly the hazards are described (including equipment failures, personnel errors etc) the easier it will be to find the CCP.
CD/Recorded
$199
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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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