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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
Navigating the maze of changes with Form 5500

Navigating the maze of changes with Form 5500

  • Speaker: Cathleen M. Hampton
  • Product ID: 704588
  • Duration: 90 Min
This webinar will discuss practical information to ensure compliance with the myriad of changes made to Form 5500 filing requirements. The Instructor will discuss EFAST2 processes and Schedule C disclosures and review changes to the 2014 Form 5500 series reports and 2015 Form 5500-SUP draft instructions. Participants will understand audit requirements and how to handle late deposits.
CD/Recorded
$249
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Recorded/CD
CMS Hospital CoP and TJC Telemedicine Standards, Telemedicine Credentialing and Privileging

CMS Hospital CoP and TJC Telemedicine Standards, Telemedicine Credentialing and Privileging

  • Speaker: Sue Dill Calloway
  • Product ID: 705491
  • Duration: 2 hrs
This webinar will give insights on regulations and CMS interpretive guidelines which are now part of the hospital CoPs on telemedicine credentialing. It will discuss CMS mechanism for all hospitals to use proxy credentialing with Medicare-certified hospitals or other telemedicine entities. It will further discuss why written agreement is required, and insights on the requirements in the written agreement. It will also provide insights on standards, Joint Commission has on telemedicine in the leadership chapter.
CD/Recorded
$249
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Recorded/CD
How to Transition from Paper to Electronic Records in a Regulatory Environment

How to Transition from Paper to Electronic Records in a Regulatory Environment

  • Speaker: Charlie Sodano
  • Product ID: 703576
  • Duration: 75 Min
This webinar will cover effective and efficient ways to transition from paper to electronic records in a regulated environment. It will address compliance issues, complexity in decision making and implications specific to the pharmaceutical industry.
CD/Recorded
$249
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Recorded/CD
Credit card surcharging - who is going to do it and what are the stipulations for compliance?

Credit card surcharging - who is going to do it and what are the stipulations for compliance?

  • Speaker: Ray Graber
  • Product ID: 702866
  • Duration: 60 Min
This training on credit card surcharges compliance will discuss how the recent changes in law will affect end-user organizations. It will also provide attendees with the tools necessary to review and deal with any potential surcharge/checkout fee situations.
CD/Recorded
$249
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Recorded/CD
Preparing Compliant eCTD Submissions: Are You Prepared for Upcoming FDA Mandate on e-Submissions?

Preparing Compliant eCTD Submissions: Are You Prepared for Upcoming FDA Mandate on e-Submissions?

  • Speaker: Peggy Berry
  • Product ID: 705349
  • Duration: 60 Min
This webinar will review the CTD format requirements including documentation and technical requirements for an eCTD submissions. It will help attendees prepare for implementing the FDA upcoming mandates on e-submissions.
CD/Recorded
$10
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Recorded/CD
Good Practices for Data Integrity, the new Guidance and one FDA Inspector's Experience

Good Practices for Data Integrity, the new Guidance and one FDA Inspector's Experience

  • Speaker: John R Godshalk
  • Product ID: 704806
  • Duration: 60 Min
This webinar, by an ex-FDA, will cover Good Data Integrity Practice for GxP environments. Participants will understand what FDA looks for with regard to data integrity, what may need to be audited, the new guidance and application of data integrity, and relevant regulations for data integrity
CD/Recorded
$249
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Recorded/CD
Family Medical Leave Statutes for Small and Medium Business

Family Medical Leave Statutes for Small and Medium Business

  • Speaker: Matthew W Burr
  • Product ID: 705268
  • Duration: 60 Min
This training program will describe the scope, objective and domain of FMLA. It will help identify most frequent types of FMLA abuse and discuss case studies on FMLA abuses. The webinar instructor will also discuss best practices to carry out effective FMLA investigation and highlight documentation guidelines that will help your company stay out of court and avoid settling claims.
CD/Recorded
$179
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Recorded/CD
Practical Risk Appetite and Risk Tolerance

Practical Risk Appetite and Risk Tolerance

  • Speaker: Mario Mosse
  • Product ID: 704949
  • Duration: 90 Min
This webinar will discuss how to implement and monitor risk policy. The instructor will explain the challenges and opportunities involved in developing and implementing an effective risk appetite statement, which is supported by risk limits, and the determination of actual exposure against those limits and risk tolerance.
CD/Recorded
$229
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Recorded/CD
How to Conduct a HIPAA Risk Assessment

How to Conduct a HIPAA Risk Assessment

  • Speaker: Brian Tuttle
  • Product ID: 704592
  • Duration: 60 Min
This training program will cover the proper methodologies of conducting a HIPAA risk assessment based on the formula used by federal auditors and based on the NIST (National Institute of Standard for Technologies) guidelines. The session will also cover the most important aspects to be aware of in terms of the federal auditing process as well as the new risks regarding patients suing for wrongful disclosures.
CD/Recorded
$249
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Recorded/CD
Patients Suing Under HIPAA

Patients Suing Under HIPAA

  • Speaker: Brian Tuttle
  • Product ID: 704387
  • Duration: 60 Min
This training program will be addressing major changes under the Omnibus Rule which give patients the right to sue under state law citing HIPAA. There are enormous issues and risks for covered entities and business associates under Omnibus.
CD/Recorded
$249
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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
Developing Effective Workers Compensation Case Management Strategies

Developing Effective Workers Compensation Case Management Strategies

  • Speaker: Joe Keenan
  • Product ID: 705315
  • Duration: 90 Min
Workplace injuries and illnesses can cause huge financial tolls and disrupt the workforce in an organization. This webinar will dive into the importance of developing an effective Return to Work program and presenting the program to senior management.
CD/Recorded
$179
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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
Form I-9 and E-Verify, Getting and Staying Compliant

Form I-9 and E-Verify, Getting and Staying Compliant

  • Speaker: Cathleen M. Hampton
  • Product ID: 703756
  • Duration: 120 Min
Today, in order to avoid astronomical fines for non-compliance, employers need to be ever so vigilant and diligent in their process. This webinar discussion will include a review of the penalties ICE and Office of Special Counsel (OSC) can impose. Additionally, the webinar will review paper versus electronic I-9 forms and the common mistakes employers make in the process.
CD/Recorded
$149
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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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