ComplianceOnline

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!

Recorded/CD
FMLA Abuse: How to Identify, Investigate, Deny, and Terminate

FMLA Abuse: How to Identify, Investigate, Deny, and Terminate

  • Speaker: Vanessa G Nelson
  • Product ID: 703671
  • Duration: 60 Min
This webinar will assist employers with effective strategies to identify, investigate, and terminate FMLA abusers. Additionally, the course will also instruct employers on when it is appropriate to deny FMLA requests in accordance with the law.
CD/Recorded
$199
Recorded/CD
Transfer of Analytical Methods According to the USP Chapter <1224>

Transfer of Analytical Methods According to the USP Chapter <1224>

  • Speaker: Dr. Ludwig Huber
  • Product ID: 701971
  • Duration: 75 Min
This webinar will explain the final version of USP Chapter <1224> and FDA guidance for conducting and documenting method transfer between laboratories and sites, and provide tools for effective implementation.
CD/Recorded
$179
Recorded/CD
How to Structure and Write a Job Hazard Analysis / Activity Hazard Analysis (JHA – AHA) in Accordance with OSHA 1926 – EM 385

How to Structure and Write a Job Hazard Analysis / Activity Hazard Analysis (JHA – AHA) in Accordance with OSHA 1926 – EM 385

  • Speaker: John J Meola
  • Product ID: 705500
  • Duration: 90 Min
This webinar will explore the common failures associated with organizing and writing Job Hazard Analysis / Activity Hazard Analysis (JHA – AHA) documents. It will also de-mystify some of the language and concepts in the traditional JHA process, namely the risk assessment calculator.
CD/Recorded
$199
Recorded/CD
Customs Entry Reconciliation Program - Valuation Errors and Penalties

Customs Entry Reconciliation Program - Valuation Errors and Penalties

  • Speaker: Raymond Sullivan
  • Product ID: 704815
  • Duration: 60 Min
This webinar will explain how to calculate the correct valuation on a product while importing from related party suppliers. Instructor will discuss how to document transactions for CBP process and to recognize valuation issues that may cause price adjustments after import. Participants will learn to avoid adverse consequences of declared valuation errors and what are the downsides to participation in reconciliation.
CD/Recorded
$199
Recorded/CD
ICH Stability Requirements and Challenges

ICH Stability Requirements and Challenges

  • Speaker: Wayland Rushing
  • Product ID: 704585
  • Duration: 60 Min
This training program will detail the requirements for ICH stability studies, discuss how to design stability programs for your drug product, and list analytical methods requirements. It will also focus on how to interpret the data generated by the stability programs.
CD/Recorded
$279
Recorded/CD
How to Structure and Write an Occupational Safety & Health Plan

How to Structure and Write an Occupational Safety & Health Plan

  • Speaker: John J Meola
  • Product ID: 705429
  • Duration: 90 Min
This webinar will describe the elements and characteristics necessary for the development and writing of an occupational health and safety Plan. The main component of this Plan will be your ‘Company Safety Manual” however the actual Plan will encompass far more than a Manual.
CD/Recorded
$179
Recorded/CD
HIPAA Texting and Emailing | Myths vs Realities

HIPAA Texting and Emailing | Myths vs Realities

  • Speaker: Brian Tuttle
  • Product ID: 704519
  • Duration: 60 Min
This training program will go into great detail regarding you practice or business information technology and how it relates to the HIPAA Security Rule, in particular portable devices. Areas covered will be texting, email, encryption, medical messaging, voice data and risk factors as they relate to IT.
CD/Recorded
$249
Recorded/CD
Untangling the FMLA and ADA Overlap Puzzle to Avoid Employment Litigation

Untangling the FMLA and ADA Overlap Puzzle to Avoid Employment Litigation

  • Speaker: Vanessa G Nelson
  • Product ID: 704305
  • Duration: 60 Min
This FMLA and ADA training program will discuss why it is crucial for employers to have at least a basic knowledge of the laws to apply them correctly and avoid litigation. Both the FMLA and ADA are confusing laws on their own. When there is an overlap between the laws, it can be even more confusing, frustrating, and almost impossible to manipulate. The key to untangling ADA and FMLA is to understand the obligations under each statute.
CD/Recorded
$199
Recorded/CD
Medical Device Tracking Requirements

Medical Device Tracking Requirements

  • Speaker: Vanessa Lopez
  • Product ID: 705192
  • Duration: 60 Min
Medical Device Tracking is a very important aspect of the distribution chain of a medical device. This is because it is critical to have a mechanism by which a medical device can be traced and located in its place after it leaves the manufacturer. This system of tracking helps to identify a defective device and ensure that corrective measures are taken immediately.
CD/Recorded
$169
Recorded/CD
California Meal and Rest Periods

California Meal and Rest Periods

  • Speaker: Kristin Robinson
  • Product ID: 705474
  • Duration: 60 Min
Learn what constitutes a meal or rest break and your obligations as an Employer under California's employee break laws. Understand the requirements and the possible violations and penalties associated with CA meal and rest break compliance
CD/Recorded
$179
Recorded/CD
Structuring Physician Practice Acquisitions: Key Stark Law Considerations

Structuring Physician Practice Acquisitions: Key Stark Law Considerations

  • Speaker: Joseph Wolfe
  • Product ID: 705152
  • Duration: 60 Min
In this session Mr. Wolfe will provide an overview of the Stark Law, including its 2016 changes. He will also discuss best practices for negotiating and drafting physician practice acquisition arrangements on behalf of health systems, hospitals, medical groups and physician practices. The webinar will focus on regulatory requirements, key provisions, valuation considerations and potential pitfalls that should be avoided.
CD/Recorded
$249
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
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
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
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
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
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
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
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
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
Best Sellers
You Recently Viewed
    Loading