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Home › Online Training ›  Risk Management & Controls

Risk Management and Controls Regulatory Compliance Training - Live Webinars, Recordings & CDs

The risk management courses on this page are designed to help you strengthen your professional profile and add value to your organization. These courses will help you get insights associated with the numerous laws pertaining to risk management. You will learn how to manage business risks such as developing risks around competition, operational strategies, vendor risk management, establishing meaningful metrics, avoiding decision-making errors, and much more.
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Recorded/CD
Changes to Good Pharmacovigilance Practices in the EU

Changes to Good Pharmacovigilance Practices in the EU

  • Speaker: Robert J Russell
  • Product ID: 702341
  • Duration: 90 Min
This 90-minute webinar will provide you a thorough understanding of the updated framework surrounding Good Pharamcovigilance Practices (GVP) in the EU. This will include updates to the EU regulation, Directive and the first seven PV Modules, which have been published for consultation.
CD/Recorded
$229
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Recorded/CD
Full-day Virtual Seminar : Navigating the Japan Regulatory and Clinical Trial Environment; Conducting Clinical Studies in Japan

Full-day Virtual Seminar : Navigating the Japan Regulatory and Clinical Trial Environment; Conducting Clinical Studies in Japan

  • Speaker: Robert J Russell
  • Product ID: 702170
  • Duration: 6 hrs
This Japan Regulatory and Clinical Trial Requirements training will cover Japan Regulatory Agency Structure and Responsibilities, its review process for decision-making and approval, requirements for clinical trials in Japan and the procedures for conducting clinical studies in the country and reporting them.
CD/Recorded
$1099
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Recorded/CD
Clinical Trial Auditing - Identifying risks and building a more compliant and successful trial

Clinical Trial Auditing - Identifying risks and building a more compliant and successful trial

  • Speaker: Madhavi Diwanji
  • Product ID: 701980
  • Duration: 90 Min
This Clinical trial auditing training will provide an understanding of how to conduct compliant and successful clinical trials by defining FDA clinical trial audit procedures, audit program, audit planning and audit preparation.
CD/Recorded
$229
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Recorded/CD
Election Year Legal and Compliance 2012

Election Year Legal and Compliance 2012

  • Speaker: Michael Bayes ,Jason Torchinsky
  • Product ID: 702228
  • Duration: 75 Min
This webinar on Federal Campaign Finance Law will assist compliance officers and in-house counsel identify common campaign finance issues faced by corporations and trade associations in major election years.
CD/Recorded
$149
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Recorded/CD
Medical Device Risk Management Using ISO 14971

Medical Device Risk Management Using ISO 14971

  • Speaker: Daniel O Leary
  • Product ID: 701268
  • Duration: 90 Min
This webinar explains the application of Risk Management for medical devices using ISO 14971:2007. It explains the flow of information from the Risk Management Plan to the Risk Management Report, looking at important terms including Hazard, Harm, and Risk and explaining how to use each one. The program describes development of a Risk Evaluation form that implements the requirements of ISO 14971.
CD/Recorded
$349
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Recorded/CD
Clinical Trial auditing - Identifying risks and building a more compliant and successful trial

Clinical Trial auditing - Identifying risks and building a more compliant and successful trial

  • Speaker: Peter Calcott
  • Product ID: 701214
  • Duration: 90 Min
This Clinical trial auditing training will provide valuable assistance how to conduct clinical trials both using internal resources and also those that outsource the function to CRO’s in pharmaceutical and biotech industries. How to assure your clinical trials are in compliance and meet the agencies requirements.
CD/Recorded
$249
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Recorded/CD
Gamma Sterilizer Validation: Method 1 and VDmax25 per ISO 11137

Gamma Sterilizer Validation: Method 1 and VDmax25 per ISO 11137

  • Speaker: Mark Dott
  • Product ID: 701255
  • Duration: 60 Min
This Sterilization validation training will review the general requirements for validation as described in ISO 11137:2006.
CD/Recorded
$109
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Recorded/CD
Managing Corporate Risks with ISO 31000

Managing Corporate Risks with ISO 31000

  • Speaker: Kelly Eisenhardt
  • Product ID: 705083
  • Duration: 60 Min
ISO 31000 is a standard developed by the International Organization for Standardization (ISO) which provides a basic guideline and principles for the application of risk management. Companies that use risk management processes vary across industries in scope and magnitude and address a wide variety of challenges. This training program will offer an in depth look into the key components of the ISO 31000 guideline and best practices to implement and support a corporate risk management strategy or program.
CD/Recorded
$0
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Recorded/CD
Advanced Risk Analysis Techniques

Advanced Risk Analysis Techniques

  • Speaker: Richard Cascarino
  • Product ID: 702722
  • Duration: 60 Min
Corporations are facing more risks in the expanded environment of business. This webinar will provide auditors and audit management with advanced approaches to risk management and internal risk assessment at a corporate level.
CD/Recorded
$0
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Recorded/CD
Introduction to disaster/emergency management and business continuity programs

Introduction to disaster/emergency management and business continuity programs

  • Speaker: Bill Greulich
  • Product ID: 701337
  • Duration: 60 Min
This Risk management training module will describe a common set of criteria for disaster/emergency management and business continuity programs.
CD/Recorded
$199
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Recorded/CD
Product Risk Management under FDA and ISO 14971:2007

Product Risk Management under FDA and ISO 14971:2007

  • Speaker: John E Lincoln
  • Product ID: 701176
  • Duration: 60 Min
This Product risk management training/webinar for Medical devices will help in to develop a compliant Hazard Analysis / Risk Management File and Report, as outlined in the newly revised ISO 14971:2007. The US FDA is increasingly stating that many regulated activities should be “risk-based”. Major resource-consuming activities such as product and process / equipment / facility, and software validation, CAPA investigations, vendor audits can all be tailored to a risk based approach. This eliminates the current SOP-defined “one size fits all” approach, to a flexible, resource adjusted approach, less arbitrarily defined in an SOP, but yielding results targeted to real needs. Attendees will be helped to see how to develop a compliant Hazard Analysis / Risk Management File and Report, as outlined in the newly revised ISO 14971:2007, a standard recognized by the FDA and rapidly being adopted by industry. Then how to use this document to accomplish the above goals.
CD/Recorded
$0
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Recorded/CD
Evaluating the Effectiveness of your ERM Program: Linking shareholder value with superior governance and ERM

Evaluating the Effectiveness of your ERM Program: Linking shareholder value with superior governance and ERM

  • Speaker: David R Koenig,Dr. Robert Mark
  • Product ID: 701231
  • Duration: 60 Min
This Enterprise Risk Management training (ERM) will provide a framework for evaluating the effectiveness of risk management based on an inventory of questions an effective ERM program should be able to answer.
CD/Recorded
$249
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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
Using ICH Q9 and Recent FDA Comments as the Foundation for the Planning, Development and Execution of Risk-Based Cleaning Validation Studies

Using ICH Q9 and Recent FDA Comments as the Foundation for the Planning, Development and Execution of Risk-Based Cleaning Validation Studies

  • Speaker: John Hyde
  • Product ID: 701184
  • Duration: 90 Min
This Cleaning validation training will provide valuable assistance to all regulated companies that need to develop and validate their equipment cleaning processes. This session will address risk-based approaches to cleaning validation studies using ICH Q9 and recent FDA comments and observations as a foundation. Recent FDA warning letters illustrate just how critical good cleaning practices are. Understanding and employing good cleaning practices are instrumental to improving cleaning consistency, quality and traceability. The FDA favors automated CIP systems since they reduce operator variability while enhancing consistency and reproducibility. Our research has indicated that in the last 5 years, cleaning citations were noted in 50% of warning FDA letters. Many cited contamination issues have an element of poor cleaning practices associated with them. Examples include “investigations…did not include an evaluation of the cleaning processes and procedures…to determine if equipment cleaning is effective in preventing cross contamination of the inactivated batches”, FDA Warning Letter, Jan 2008; "vaccine manufacturing plant in Pennsylvania, has been served with an FDA warning letter asking for measures to ensure batches of its flu shot ingredients do not become contaminated again.” Jul-2006..

An overview of ICH risk management techniques and how to apply them to equipment cleaning programs will be discussed. In addition, case studies from manufacturing facilities will be used to illustrate risk-based cleaning validation principles and practices.
CD/Recorded
$299
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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
Risk Management and the Risk Assessment Process

Risk Management and the Risk Assessment Process

  • Speaker: Bernice Russell Bond
  • Product ID: 701047
  • Duration: 90 Min
This Risk Management training will cover Risk management & Risk assessment within all business processes. Risk management is a concern that must be taken seriously in all aspects of your business. Are you prepared for the problems you may face?
CD/Recorded
$249
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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
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
Validating spreadsheets: strategies for satisfying FDA requirements

Validating spreadsheets: strategies for satisfying FDA requirements

  • Speaker: Alfonso Fuller
  • Product ID: 700969
  • Duration: 90 Min
This presentation explores strategies for recognizing when validation is required, how to achieve compliance and what documentation needs to be generated and maintained.
CD/Recorded
$299
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Recorded/CD
Process Validation, planning, strategy, requirements, risk assessment, design description

Process Validation, planning, strategy, requirements, risk assessment, design description

  • Speaker: Peter Calcott
  • Product ID: 700891
  • Duration: 60 Min
While simple to describe many companies fall into the trap of territoriality, and confusion of roles and responsibilities. This webinar will walk through the elements of a process validation program for biological products with an emphasis on the involvement of all functions especially process development.
CD/Recorded
$249
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