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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
Validation and Use of Cloud Computing in FDA Regulated Environments

Validation and Use of Cloud Computing in FDA Regulated Environments

  • Speaker: Dr. Ludwig Huber
  • Product ID: 703423
  • Duration: 75 Min
This webinar will discuss FDA requirements related to cloud computing. It will provide step-by-step recommendations for using 'clouds' from planning to reporting.
CD/Recorded
$249
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Recorded/CD
Stability Programs for Leachable Impurities

Stability Programs for Leachable Impurities

  • Speaker: Wayland Rushing
  • Product ID: 704685
  • Duration: 60 Min
This training program will closely examine what are extractables and leachables. It will focus on how to design and implement leachable stability programs, including the requirements for leachable stability programs, developing and validating methods for use in leachable stability programs, and drug product impurities vs. leachable impurities.
CD/Recorded
$199
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Recorded/CD
Data Integrity in the Pharmaceutical Laboratory: Practical Steps to Identify and Avoid Data Integrity Issues

Data Integrity in the Pharmaceutical Laboratory: Practical Steps to Identify and Avoid Data Integrity Issues

  • Speaker: Gregory Martin
  • Product ID: 705347
  • Duration: 90 Min
This webinar will discuss in detail the fundamentals of data integrity including the FDA guidance document. It will teach attendees practical steps to identify and avoid data integrity issues in pharmaceutical laboratory.
CD/Recorded
$199
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Recorded/CD
Construction, Engineering and Scientific Cost Estimating as per OSHA 29 CFR

Construction, Engineering and Scientific Cost Estimating as per OSHA 29 CFR

  • Speaker: Keith Warwick
  • Product ID: 705162
  • Duration: 75 Min
This training program will break down the essential elements covered under OSHA 29 CFR 1910 and 29 CFR 1926 with respect to construction, engineering and scientific cost estimating. In particular, the webinar will discuss techniques for preparing rough estimates, techniques for evaluating and estimating scientific processes, contingencies, overhead and profit, estimating cost of new construction, estimating costs of environmental remediation, and more.
CD/Recorded
$199
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Recorded/CD
Extractables and Leachables in Early Phase Development

Extractables and Leachables in Early Phase Development

  • Speaker: Wayland Rushing
  • Product ID: 704517
  • Duration: 60 Min
This training program will offer insight into where extractables and leachables come from. Attendees will learn the regulatory expectations and trends for extractables and leachables in early phase development and learn which products may require E&L data in early phases. The program will also focus on how to design programs to meet the needs of early phase development – i.e. phase appropriate E&L programs.
CD/Recorded
$179
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Recorded/CD
Residual Solvents: Take Advantage of the New Flexibility in Revised USP <467>

Residual Solvents: Take Advantage of the New Flexibility in Revised USP <467>

  • Speaker: Gregory Martin
  • Product ID: 705325
  • Duration: 90 Min
This webinar provides understanding of the requirements for residual solvents addressed in ICH, USP, EP and JP and focus on the recent changes to USP <467>. It will also help attendees utilize strategies to minimize the testing and resources required to meet the requirements.
CD/Recorded
$249
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Recorded/CD
Safe Use of Ladders and Proper Climbing Practices; Fall Protection on Aerial Lifts; Proper Use of Staging

Safe Use of Ladders and Proper Climbing Practices; Fall Protection on Aerial Lifts; Proper Use of Staging

  • Speaker: John J Meola
  • Product ID: 705493
  • Duration: 90 Min
This webinar will review the best practices associated with use of ladders of all types, including the selection, inspection, storage and transport of ladders, along with safe practice when erecting, climbing, working from and descending a ladder. It will also discuss the process and practices related with aerial lifts and working from buckets on an extended boom.
CD/Recorded
$179
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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
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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
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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
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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
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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
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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
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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
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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
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Recorded/CD
W-2s vs. 1099s - Who Should be an Independent Contractor

W-2s vs. 1099s - Who Should be an Independent Contractor

  • Speaker: Vicki M. Lambert
  • Product ID: 703936
  • Duration: 90 Min
This training program will concentrate on the requirements to classify a worker as an independent contractor or as an employee under the IRS rules. The course will further illustrate how the FLSA rules differ from the IRS rules and why you must follow both.
CD/Recorded
$149
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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
$219
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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
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Recorded/CD
Conducting Effective Quality Audits: Beyond Audit Checklists

Conducting Effective Quality Audits: Beyond Audit Checklists

  • Speaker: Andrew Campbell
  • Product ID: 703539
  • Duration: 60 Min
This webinar will teach attendees best practices for conducting effective quality audits to ensure regulatory compliance. Learn how to avoid potential pitfalls during the audit process.
CD/Recorded
$249
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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
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