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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
A Durable Medical Equipment Revenue Program Every Practice Should Have

A Durable Medical Equipment Revenue Program Every Practice Should Have

  • Speaker: Gregory J Simms
  • Product ID: 704694
  • Duration: 60 Min
This training program on durable medical equipment revenue program for medical practitioners will discuss determining business opportunities and determining a financial ROI and a strategic ROI. It will also discuss how to develop policies, processes and business guidelines to make your program successful.
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Recorded/CD
Performing an Effective Risk Assessment of Potential Breaches

Performing an Effective Risk Assessment of Potential Breaches

  • Speaker: Frank Ruelas
  • Product ID: 704682
  • Duration: 60 Min
The Health Insurance Portability and Accountability Act (HIPAA) rules and regulations clearly state that an impermissible use or disclosure is presumed to be a breach. Therefore, any such incident triggers the required notifications. However, if an organization performs a risk assessment and shows why the incident is not a breach, the required notifications would no longer apply. This training program will focus on how to perform an effective risk assessment that can not only reduce the administrative burden of dealing with presumed breaches, but also help an organization meet other criteria such as those that exist in the Office for Civil Rights HIPAA audit protocol.
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Recorded/CD
Measuring and Managing Customer Profitability - From Growing Sales to 'Profitable' Sales

Measuring and Managing Customer Profitability - From Growing Sales to 'Profitable' Sales

  • Speaker: Gary Cokins
  • Product ID: 704679
  • Duration: 90 Min
This training program will focus on how to shift the mindset from growing sales to growing profitable sales and to view customers as investments like in a stock portfolio to seek higher ROIs – return on customers (ROC). It will also look at how measuring forward-looking customer lifetime value (CLV) differs from calculating historical customer/consumer profitability for B2C industries.
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Recruitment and Informed Consent: The Cornerstone of Ethical Clinical Research

Recruitment and Informed Consent: The Cornerstone of Ethical Clinical Research

  • Speaker: Jennifer Holcomb
  • Product ID: 704289
  • Duration: 60 Min
At the end of this training program, participants will be able to differentiate between consent and assent, identify when to use the long form and when to use the short form, describe the consent process using best practices.
CD/Recorded
$229
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Recorded/CD
FDA IDE: Investigational Device Exemption - What You Need To Know

FDA IDE: Investigational Device Exemption - What You Need To Know

  • Speaker: Kesley Tyson
  • Product ID: 704639
  • Duration: 60 Min
This program will identify regulations and guidelines pertaining to investigational device exemptions. Participants will learn to translate regulations and guidelines into practical application. The program will also discuss the dos/don’ts for conducting device trial activities through real-life examples.
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Recorded/CD
Protecting Your Intellectual Property Abroad

Protecting Your Intellectual Property Abroad

  • Speaker: Douglas Cohen
  • Product ID: 702972
  • Duration: 60 Min
IP piracy costs more than a loss in sales. If your brand loses value because it is seen as less exclusive or is confused with poor imitations this poses a long term threat to profitability. Re-establishing brand identity and company reputation is expensive if not impossible. This webinar will provide specific, practical steps to take to lessen this risk of loss.
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Recorded/CD
CDISC Cloud Computing in the Pharmaceutical Industry: Paradigm Shift in Project Management, Analysis and Validation

CDISC Cloud Computing in the Pharmaceutical Industry: Paradigm Shift in Project Management, Analysis and Validation

  • Speaker: Sunil Gupta
  • Product ID: 704674
  • Duration: 75 Min
This training program will help you better manage projects and offer practical tools to understand data content and quality. Attendees will learn to apply validation methods to reduce time to validate clinical summary tables. Attendees will also learn to apply advanced SAS programming techniques to standardize and automate the validation process.
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CAMELS Methodology | Market Risk Identification, Evaluation and Managing Risk Conditions - CCAR and CLAR

CAMELS Methodology | Market Risk Identification, Evaluation and Managing Risk Conditions - CCAR and CLAR

  • Speaker: Robert Geary
  • Product ID: 704669
  • Duration: 60 Min
This training webinar discusses CAMELS components in terms of the regulators’ evaluation methodology. It covers how these considerations translate into the rating of each component and the formulation of a bank’s CAMELS composite rating. In addition, the instructor explains two related evaluations: CCARS which is a “Comprehensive Capital Assessment and Review”, and CLAR which is a “Comprehensive Liquidity Assessment and Review” and how to rate bank’s capital adequacy and liquidity adequacy.
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Recorded/CD
Implementing the Affordable Care Act and Discrimination Laws into your Organization's Wellness Program: Critical Information to Avoid Liability

Implementing the Affordable Care Act and Discrimination Laws into your Organization's Wellness Program: Critical Information to Avoid Liability

  • Speaker: Dr. Susan Strauss
  • Product ID: 704663
  • Duration: 90 Min
A Harvard research study suggested that wellness programs may provide up to a 6:1 dollar return on investment! Organizations with wellness programs report a 15% slower rise in healthcare costs. This training will help participants in creating a comprehensive wellness and disease prevention program to improve employee health while decreasing the employer’s healthcare costs. The participants will understand challenges: employee discrimination based on disability, race, or gender, and how to incorporate non-discriminatory options in their wellness strategy.
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Proper Implementation: The Key to Success With Lean for Your Healthcare Organization

Proper Implementation: The Key to Success With Lean for Your Healthcare Organization

  • Speaker: Samuel Thomas Zidel
  • Product ID: 704616
  • Duration: 60 Min
This Lean implementation training program will guide attendees in understanding why organizations fail at Lean implementation. It will detail best practices for utilizing the Lean implementation model and recognizing the importance of creating a Lean culture. The program will also help create systems thinking by eliminating departmental silos.
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Recorded/CD
Pharmaceutical Company Specific Records and Information Management Programs

Pharmaceutical Company Specific Records and Information Management Programs

  • Speaker: Charlie Sodano
  • Product ID: 704667
  • Duration: 60 Min
This training program will focus on creating a workable and effective records and information policy. It will also discuss establishing records and information management responsibilities, determining the locations of all information resources, planning long term archiving, and content and records management software considerations and options.
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Recorded/CD
Global Considerations for Supplements and Nutritional Products

Global Considerations for Supplements and Nutritional Products

  • Speaker: James Russell
  • Product ID: 704666
  • Duration: 90 Min
This training program will discuss global considerations for supplements and nutritional products as well as the country/region specific considerations for them. It will also elaborate healthcare authorities’ outlook, global expansion challenges, product classification, and marketing challenges in the industry.
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FDA Compliance and Laboratory Computer System Validation

FDA Compliance and Laboratory Computer System Validation

  • Speaker: Carolyn Troiano
  • Product ID: 704660
  • Duration: 60 Min
Upon completion of this training program, attendees will have an understanding of laboratory system computer validation planning, execution and management concepts, based on the System Development Life Cycle (SDLC) framework. They will have received the guidance on industry best practices necessary to develop a compliant and cost-effective validation program. They will understand the steps for validating laboratory systems, along with the key documentation associated with maintaining the systems in a validated state, while minimizing costs. Attendees will gain a good grasp of how to leverage these practices across all systems by creating a standardized program.
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Developing HIPAA Policies and Procedures

Developing HIPAA Policies and Procedures

  • Speaker: Jay Hodes
  • Product ID: 704657
  • Duration: 60 Min
This training program will engage attendees in understanding why it is critical for anyone tasked with managing a HIPAA compliance program to have comprehensive policies and procedures in place. Find out how to create policies and procedures or see if your current ones address all the required topics.
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Recorded/CD
Wage and Hour Compliance Under the New Regulations - Part 3

Wage and Hour Compliance Under the New Regulations - Part 3

  • Speaker: Bob McKenzie
  • Product ID: 704635
  • Duration: 60 Min
The proposed changes to the salary level to qualify for an exemption will have a huge effect on traditional pay practices of most organizations. This training program will explore how the potential cost of not complying will also rise substantially. Business managers and HR professionals have to know what the new regulations are, how they will affect their business model, if the changes will increase the cost of labor and how to communicate the changes to affected employees.
CD/Recorded
$249
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Recorded/CD
The Federal Fair Credit Reporting Act (FCRA) and Background Checks

The Federal Fair Credit Reporting Act (FCRA) and Background Checks

  • Speaker: Lester S Rosen
  • Product ID: 704456
  • Duration: 75 Min
This webinar training will explain the Federal Fair Credit Reporting Act (FCRA) and how it affects the pre-screening and investigation process of current employees. It will discuss the regulations and law that employers should comply with while hiring new employees to avoid getting into legal issues in future. Participants will learn about the best practices and regulatory requirements regarding background checks, pre-screening and investigation for safe hiring.
CD/Recorded
$249
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Recorded/CD
Standards and Their Role in Medical Device and Patient Safety

Standards and Their Role in Medical Device and Patient Safety

  • Speaker: Lena Cordie Bancroft
  • Product ID: 704654
  • Duration: 90 Min
This training program will explore the relationship of standards to medical device legal requirements. It will clarify the standards development process and discuss relationship of standards to patient safety.
CD/Recorded
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Compensation Systems Explained: Essential of Creating Pay Structures

Compensation Systems Explained: Essential of Creating Pay Structures

  • Speaker: Wes Pruett
  • Product ID: 704653
  • Duration: 90 Min
In this training program, participants will understand the fundamental concepts of creating a compensation system. They will receive information on the concepts of: compensation policy, internal and external equity, ranges, grades, position analysis, job evaluation systems, point factor systems, benchmark positions, using market analysis to establish pay ranges and midpoints, options for movement through salary ranges, and calculating compa-ratios. Sample pay grade with variable ranges will also be discussed in the session.
CD/Recorded
$229
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Recorded/CD
Don't Fear the Fork: 7 Strategies for Effective Allergen Control

Don't Fear the Fork: 7 Strategies for Effective Allergen Control

  • Speaker: Valerie Scheidt
  • Product ID: 704637
  • Duration: 60 Min
This training program is designed for food safety practitioners who are preparing for implementation of the Preventive Controls Rule, and require assistance in effectively managing allergens. Those who have an existing allergen control program realize that though a plan is in place, compliance and ongoing monitoring is essential for success. Operations which have formally relied upon the standards as set forth by certification bodies may wish to reconsider their approach based upon the finalization of the PC Rule.
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ICH Addendum and its Implication on Clinical Development

ICH Addendum and its Implication on Clinical Development

  • Speaker: Beat Widler
  • Product ID: 704636
  • Duration: 60 Min
This training program will discuss investigator oversight and responsibilities, records management including source data, trial data handling and procedures, quality and risk management, vendor oversight and subcontracting, risk-based monitoring and last but not least root cause analyses in case of non-compliances.
CD/Recorded
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