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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
Using Analysis of Variance - A Practical Approach

Using Analysis of Variance - A Practical Approach

  • Speaker: Daniel O Leary
  • Product ID: 703824
  • Duration: 60 Min
This training program will illustrate the underlying idea that makes ANOVA work. It will also offer an understanding of the data collection issues you should plan and how to get access to ANOVA in Excel.
CD/Recorded
$229
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Recorded/CD
How to Properly Monitor Process and Performance of Pharmaceutical Solid Dosage Equipment

How to Properly Monitor Process and Performance of Pharmaceutical Solid Dosage Equipment

  • Speaker: Michael Levin
  • Product ID: 704274
  • Duration: 60 Min
Among other key topics, this training program will focus on what can be monitored in mixing operations, wet granulation operations, dry granulation operations, compaction operations, and coating operations.
CD/Recorded
$229
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Recorded/CD
Making Sense of BSCs, Hoods, Isolators, RABs

Making Sense of BSCs, Hoods, Isolators, RABs

  • Speaker: Joseph Winslow
  • Product ID: 704361
  • Duration: 60 Min
Attendees will come away from the training program with the tools they need to understand the various types of enclosures and how to select the correct type of enclosure for their process in order to meet regulations, protect the product, and ensure worker safety. The course is apt for personnel in FDA regulated industries who want to learn about what enclosure is best suited for their process and why.
CD/Recorded
$229
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Recorded/CD
Out in the Open: Protecting Your Privacy and Identity in the Digital Age on the Internet

Out in the Open: Protecting Your Privacy and Identity in the Digital Age on the Internet

  • Speaker: Joseph Rosner
  • Product ID: 704256
  • Duration: 60 Min
This privacy protection in the digital age training program will detail what the Internet of Things is and how it collects data and tracks you. It will further examine the risks attached to personal information and more.
CD/Recorded
$0
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Recorded/CD
Vendor Management - Building a Strong Questionnaire

Vendor Management - Building a Strong Questionnaire

  • Speaker: Michael D King
  • Product ID: 704119
  • Duration: 60 Min
This training program will highlight why a vendor questionnaire is the keystone your vendor management program is built on. The course will help ensure attendees get the whole picture and determine appropriate controls for information security and privacy.
CD/Recorded
$0
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Recorded/CD
ISO/IEC 27001:2013 - Breaking It Down to Understand and Implement

ISO/IEC 27001:2013 - Breaking It Down to Understand and Implement

  • Speaker: Michael C Redmond
  • Product ID: 703977
  • Duration: 90 Min
This training program will guide attendees in implementing and complying with the requirements of ISO 27001:2013. ISO 27001 is an international standard published by the International Standardization Organization (ISO), and it describes how to manage information security in a company. The latest revision of this standard was published in 2013, and its full title now is ISO/IEC 27001:2013.
CD/Recorded
$0
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Recorded/CD
How to Develop a Successful ERM Program Ensuring Synergy, Transparency and System Solutions

How to Develop a Successful ERM Program Ensuring Synergy, Transparency and System Solutions

  • Speaker: Michael C Redmond
  • Product ID: 703580
  • Duration: 60 Min
This webinar highlights the importance of an effective ERM program in project management and risk assessment. Attendees will learn how to implement a viable ERM program including documenting and testing it.
CD/Recorded
$0
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Recorded/CD
Risk Management for Medical Devices: ISO 14971:2007

Risk Management for Medical Devices: ISO 14971:2007

  • Speaker: Ronald Schoengold
  • Product ID: 700132
  • Duration: 75 Min
This training on ISO 14971:2007 will help you understand the risk management process for medical devices, including risk analysis, risk evaluation, risk control and post-production information.
CD/Recorded
$299
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Recorded/CD
The Role of the Board in Oversight of Enterprise Risk

The Role of the Board in Oversight of Enterprise Risk

  • Speaker: Douglas Webster
  • Product ID: 702708
  • Duration: 90 Min
This webinar highlights the evolution of Enterprise Risk Management (ERM), the importance of ERM in meeting board fiduciary responsibilities, and the rationale and mechanisms for ensuring effective risk management through the board.
CD/Recorded
$449
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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
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
Monitoring High Risk Transactions

Monitoring High Risk Transactions

  • Speaker: Doug Keipper
  • Product ID: 703001
  • Duration: 60 Min
This BSA/AML (Bank Secrecy Act/ Anti Money Laundering) compliance training will help attendees understand, identify and mitigate the risks associated with high risk transactions.
CD/Recorded
$0
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Recorded/CD
W-2 and W-4 Update and Best Practices

W-2 and W-4 Update and Best Practices

  • Speaker: Miles Hutchinson
  • Product ID: 704333
  • Duration: 90 Min
This webinar will prepare your staff for this filing year, improve your employee reporting set-up and maintenance practices, and reduce your risk of complaints from the IRS. Learn the latest updates on Form W-4 and Form W-2 wage and withholding reporting.
CD/Recorded
$0
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Recorded/CD
Anti-Kickback, Fraud, Stark, and Marketing - Where are the Landmines?

Anti-Kickback, Fraud, Stark, and Marketing - Where are the Landmines?

  • Speaker: William Mack Copeland
  • Product ID: 704950
  • Duration: 90 Min
This webinar will provide an in-depth understanding of the Federal False Claims Act, Federal Anti-Kickback and Stark laws, and discuss how marketing activities can trigger either or both.
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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