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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
US Expatriate Compensation Planning and Reporting Methodology

US Expatriate Compensation Planning and Reporting Methodology

  • Speaker: Matthew W Burr
  • Product ID: 705362
  • Duration: 60 Min
This webinar will offer attendees an understanding of compensation and planning for U.S. expatriates. It will assist you in preparing compensation plans, the reporting process, and in reporting expectations. The training session will also discuss variations across countries and common concerns/mistakes.
CD/Recorded
$249
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Recorded/CD
System Suitability Testing (SST) for USP and FDA Compliance

System Suitability Testing (SST) for USP and FDA Compliance

  • Speaker: Dr. Ludwig Huber
  • Product ID: 702512
  • Duration: 75 Min
Amid several other critical discussions, this training program will detail FDA and international requirements for system suitability testing; SST in comparison with equipment qualification and quality control sample analysis; critical parameters for SST in EP and USP; recommendations for implementing the updated <621>; and developing an SOP for system testing.
CD/Recorded
$249
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Recorded/CD
How to Perform a HIPAA Risk Assessment

How to Perform a HIPAA Risk Assessment

  • Speaker: James B Wener
  • Product ID: 704058
  • Duration: 60 Min
This risk assessment training will discuss why it is essential to perform a risk assessment and what kind of breaches can occur. It will also list what HIPAA regulations require and what it should tell you.
CD/Recorded
$249
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Recorded/CD
Setting Specifications for Drug Substances and Drug Products

Setting Specifications for Drug Substances and Drug Products

  • Speaker: Peggy Berry
  • Product ID: 704859
  • Duration: 90 Min
This 90-minute training will discuss the requirements of ICH for using testing and stability data to set specifications for drug substances and drug products including use of special stability studies. Attendees will also learn the requirements for changing specifications through the lifecycle of the product.
CD/Recorded
$249
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Recorded/CD
HIPAA Training for Security Officers

HIPAA Training for Security Officers

  • Speaker: Brian Tuttle
  • Product ID: 704350
  • Duration: 60 Min
This webinar will be addressing how practice/business managers (or compliance offers) need to get their HIPAA house in order before the imminent audits occur. It will also address major changes under the Omnibus Rule and any other applicable updates for 2018. The primary goal is to ensure everyone is well educated on what is myth and what is reality with this law, there is so much misleading information all over regarding the do’s and don’ts with HIPAA.
CD/Recorded
$199
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Recorded/CD
Understanding HIPAA Security Rule Requirements

Understanding HIPAA Security Rule Requirements

  • Speaker: Jay Hodes
  • Product ID: 704877
  • Duration: 60 Min
This webinar will teach you all the requirements that must be in place for the HIPAA Security Rule and how to demonstrate compliance with all the required and addressable safeguards. After completing this course, a Covered Entity or Business Associate will be able to know what needs to be place when it comes to all of the HIPAA regulations.
CD/Recorded
$199
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Recorded/CD
The Good, the Bad & the Ugly : A ‘How-to’ guide on Employee Performance Management - Module 3

The Good, the Bad & the Ugly : A ‘How-to’ guide on Employee Performance Management - Module 3

  • Speaker: Wes Pruett
  • Product ID: 704747
  • Duration: 90 Min
This training program will highlight the steps for conducting disciplinary investigations. It will discuss how to hold employees accountable for sustained change and detail a simple system for determining how to coach employees. It will also focus on Performance Improvement Plans (PIPs) and how progressive discipline policies can hurt you.
CD/Recorded
$229
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Recorded/CD
Export Documentation and Procedure

Export Documentation and Procedure

  • Speaker: Iliyana Hristev
  • Product ID: 704537
  • Duration: 90 Min
This webinar training will discuss the export documentation and procedures. The instructor will discuss the differences in documentation requirements between exporting and domestic business , how to create important documentation including commercial invoice, shipper's letter of instruction, customs and consular invoices, product specification documentation and certificates of origin
CD/Recorded
$0
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Recorded/CD
Employee Retention Toolkit : Set the Stage to meet Employee Expectation - Module 2

Employee Retention Toolkit : Set the Stage to meet Employee Expectation - Module 2

  • Speaker: Wes Pruett
  • Product ID: 704729
  • Duration: 90 Min
This training program in the three-part series will break down specific steps for conducting an effective retention interview. It will help organizations in employing a system for tracking retention in relation to risk of leaving and employee performance. It will also examine the link between employee satisfaction, motivation, and engagement and how it relates to stay interviews.
CD/Recorded
$229
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Recorded/CD
Unemployment Claims: How to Prepare for Unemployment Hearings

Unemployment Claims: How to Prepare for Unemployment Hearings

  • Speaker: Matthew W Burr
  • Product ID: 705263
  • Duration: 60 Min
This unemployment claims webinar will offer guidance on preparing for unemployment hearings. It will discuss the fact-finding process, closing statements, appealing a ruling, and the impact of the process on your organization.
CD/Recorded
$179
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Recorded/CD
Paying Health Care Providers for Quality and Value: Key Trends and Stark Law Considerations

Paying Health Care Providers for Quality and Value: Key Trends and Stark Law Considerations

  • Speaker: Joseph Wolfe
  • Product ID: 705434
  • Duration: 60 Min
This webinar will provide an overview of new quality and value based payment trends including CMS’s new quality payment program. Attendees will get a better understanding of the legal issues surrounding paying for quality and value so they can refine their current strategy and can identify new delivery models and potential opportunities.
CD/Recorded
$249
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Recorded/CD
Employers Guide to HIPAA

Employers Guide to HIPAA

  • Speaker: Kristin Robinson
  • Product ID: 705473
  • Duration: 60 Min
This webinar will cover the major provisions of the HIPAA regulations, including, healthcare access and portability, non-discrimination requirements, and privacy rules. Learn how to stay in compliance with HIPAA security rule requirements.
CD/Recorded
$179
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Recorded/CD
How to undergo an FDA Inspection Successfully

How to undergo an FDA Inspection Successfully

  • Speaker: Marie Morin
  • Product ID: 705170
  • Duration: 90 Min
This webinar will discuss best practices for preparing for an international announced inspection as well as how to be always prepared for those in the US who may be inspected at any time. It also discusses the various roles of the persons who will be assisting during the inspection and suggests how to organize support personnel to aid in keeping the inspection going smoothly and identify and address issues before FDA sees them.
CD/Recorded
$249
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Recorded/CD
The Predictive Utility of Behavior Based Interviews: A Hands-on Training with Practical Handouts - Module 1

The Predictive Utility of Behavior Based Interviews: A Hands-on Training with Practical Handouts - Module 1

  • Speaker: Wes Pruett
  • Product ID: 704705
  • Duration: 90 Min
When it comes to hiring effective employees the best interview method is undoubtedly the behavioral-based interview format where the interviewee formulates responses to specific situations he/she has actually encountered at the workplace. The concept is that past performance is the best predictor of future performance. This kind of interview format helps employers know what the employee can and cannot do based on assessing past work behaviors. This first training program in the three-part series will focus on the SOAR method (Situation – Obstacle – Action – Result) of behavioral-based interviews to help you make each department at your workplace more productive and efficient by hiring the right employees for the job.
CD/Recorded
$229
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Recorded/CD
How to Prepare for the New EU Medical Device Regulations

How to Prepare for the New EU Medical Device Regulations

  • Speaker: Richard Young
  • Product ID: 705513
  • Duration: 90 Min
The course is designed to review critical elements of the new regulations and will be run as an interactive 2 hour course designed for business leaders with a good working knowledge of current requirements.
CD/Recorded
$279
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Recorded/CD
Navigating the Regulatory Landscapes from State to State

Navigating the Regulatory Landscapes from State to State

  • Speaker: Darin Detwiler
  • Product ID: 705417
  • Duration: 60 Min
This webinar will provide participants with competitive insight into differences between states’ regulatory agencies, impact(s) of states’ funding sources on their food regulatory authority and variations in states’ history of adopting federal food policies such as FDA Food Code.
CD/Recorded
$199
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Recorded/CD
New York State Paid Family Leave: What You Need to Know Before 2018

New York State Paid Family Leave: What You Need to Know Before 2018

  • Speaker: Matthew W Burr
  • Product ID: 705242
  • Duration: 60 Min
Understand the definition of New York State paid family leave and how it will impact your organization. The webinar will also discuss the process for filing, pending changes, and its association with the FMLA.
CD/Recorded
$179
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Recorded/CD
Transgender Employees in the Workplace

Transgender Employees in the Workplace

  • Speaker: Kristin Robinson
  • Product ID: 705465
  • Duration: 60 Min
Learn how best to manage workplace issues surrounding an employee's gender transition.
CD/Recorded
$179
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Recorded/CD
The Compliance Officer's Toolkit: Best Practices for Compensating and Contracting With Physicians

The Compliance Officer's Toolkit: Best Practices for Compensating and Contracting With Physicians

  • Speaker: Joseph Wolfe
  • Product ID: 705435
  • Duration: 60 Min
This webinar will provide an overview of the technical requirements of the health care laws such as Stark Law, Anti-Kickback Statute, Civil Monetary Penalties Law, False Claims Act, etc. It will also discuss best practices that health care organizations can follow to avoid compliance traps related to these laws.
CD/Recorded
$199
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Recorded/CD
Change Control Best Practices: Avoiding Unintended Consequences of Changes

Change Control Best Practices: Avoiding Unintended Consequences of Changes

  • Speaker: Andrew Campbell
  • Product ID: 703540
  • Duration: 90 Min
This webinar will provide an overview of regulatory requirements for change control. It will focus on changes to equipment, facilities, materials/components, test methods, suppliers, specifications, etc.
CD/Recorded
$169
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