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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
Introduction to FDA and EU Medical Device Submission

Introduction to FDA and EU Medical Device Submission

  • Speaker: Charles H Paul
  • Product ID: 705065
  • Duration: 60 Min
This webinar will overview each critical aspect of the FDA submissions process to include 510(k) and PMA) and contrast those key steps to those of the EU Medical Device Directives Submissions process.
CD/Recorded
$0
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Recorded/CD
Quality Control for Microbiological Media and Reagents

Quality Control for Microbiological Media and Reagents

  • Speaker: Todd Graham
  • Product ID: 705060
  • Duration: 60 Min
This webinar will give you the tools you need to maintain a quality supply of media and reagents in a variety of microbiology laboratories. A thorough understanding of the variety of challenges necessary in maintain quality media and reagents will be brought to the fore. This will allow you to perform microbiology testing with confidence.
CD/Recorded
$169
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Recorded/CD
ISO 45001: Mitigation Essentials - Part 2

ISO 45001: Mitigation Essentials - Part 2

  • Speaker: Michael Aust
  • Product ID: 705076
  • Duration: 60 Min
This second training program in the series will review the structure of ISO 45001. It will discuss the mitigation process for the standard, the terminology associated with it, and its key requirements.
CD/Recorded
$0
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Recorded/CD
Performing an Effective Out-of-Specification Result Investigation

Performing an Effective Out-of-Specification Result Investigation

  • Speaker: Charity Ogunsanya
  • Product ID: 705064
  • Duration: 90 Min
This webinar will provide the basic understanding of how to conduct a compliant and effective out-of-specification (OOS) result investigation which is critical in preventing product recalls, voluntary and involuntary plant shut down, and FDA 483 findings or warning letter. It will also provide a basic mainframe for the Quality Assurance unit in the final disposition of the affected finished product as well as provide guidance for the different types of OOS investigational systems.
CD/Recorded
$0
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Recorded/CD
Subcontractor auditing (cGMP/Pharma/Med device industries)

Subcontractor auditing (cGMP/Pharma/Med device industries)

  • Speaker: Jan Warner
  • Product ID: 705063
  • Duration: 90 Min
This course will describe the basic principles and requirements for building a supplier audit program. This webinar will provide a framework on which to build your subcontractor auditing program.
CD/Recorded
$0
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Recorded/CD
Interview Questions and Pre-Employment Screening What Every Employer Needs to Know - Title VII, ADA/ADAAA, PDL, GINA, I-9s and Affirmative Action

Interview Questions and Pre-Employment Screening What Every Employer Needs to Know - Title VII, ADA/ADAAA, PDL, GINA, I-9s and Affirmative Action

  • Speaker: Janette Levey Frisch
  • Product ID: 703948
  • Duration: 120 Min
This training program will offer an overview of anti-discrimination laws and affirmative action issued for federal contractors; illegal and ill-advised interview questions; pre-employment tests (skills, strength, medical tests) use of social media, criminal background checks; and more.
CD/Recorded
$149
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Recorded/CD
Packaging and Labeling for Commercial and Clinical Products

Packaging and Labeling for Commercial and Clinical Products

  • Speaker: Peggy Berry
  • Product ID: 704378
  • Duration: 90 Min
This training program will discuss optimizing your packaging design for commercial and clinical products and translating a protocol into effective packaging design. Attendees will learn how to implement an effective artwork change management system. Real-life case studies and dos/don’ts for packaging and labeling for commercial and clinical products will also be discussed.
CD/Recorded
$279
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Recorded/CD
NYS Department of Labor Proposed Salary Increases

NYS Department of Labor Proposed Salary Increases

  • Speaker: Matthew W Burr
  • Product ID: 705071
  • Duration: 60 Min
With the overtime changes in New York State, this training program will discuss areas in New York State where the change will take effect. It will also discuss future changes to the rate and potential federal changes to the overtime rule.
CD/Recorded
$249
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Recorded/CD
Confined Space Rules for Construction as per OSHA Final Rule

Confined Space Rules for Construction as per OSHA Final Rule

  • Speaker: Michael Aust
  • Product ID: 705069
  • Duration: 60 Min
In this interactive training session, attendees will obtain the latest and newest OSHA regulatory information and how it effects confined spaces at you construction site. The course will also help provide practical advice on how to implement practice contractor ‘vetting’ for hiring the best employees for your organization.
CD/Recorded
$179
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Recorded/CD
Corporate Governance and the Board of Directors' Role

Corporate Governance and the Board of Directors' Role

  • Speaker: Adam Kerns
  • Product ID: 705067
  • Duration: 60 Min
This webinar will offer a comprehensive, in-depth review of the state laws affecting the corporate governance standards applicable to insurance companies and the board of directors’ role in those standards.
CD/Recorded
$199
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Recorded/CD
Strategies to Conduct a Successful Method Transfer according to FDA Expectations

Strategies to Conduct a Successful Method Transfer according to FDA Expectations

  • Speaker: Kim Huynh-Ba
  • Product ID: 705059
  • Duration: 90 Min
This webinar discusses how to execute meaningful Method Transfers by selecting appropriate analytical performance characteristics and acceptance criteria, documentation of the transfer process and how to avoid failures.
CD/Recorded
$0
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Recorded/CD
Use of Electronic Health Record Data (EHR) in FDA regulated clinical investigations

Use of Electronic Health Record Data (EHR) in FDA regulated clinical investigations

  • Speaker: Rachelle D Souza
  • Product ID: 704906
  • Duration: 60 Min
This webinar will discuss FDA’s current recommendations on using electronic health records in prospective clinical investigations of human drugs, biologics, medical devices and combination products.
CD/Recorded
$249
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Recorded/CD
Effective Discipline and Lawsuit-Proof Termination: How to Remedy Performance and Conduct Problems While Minimizing Your Legal Risks

Effective Discipline and Lawsuit-Proof Termination: How to Remedy Performance and Conduct Problems While Minimizing Your Legal Risks

  • Speaker: Susan Fahey Desmond
  • Product ID: 705058
  • Duration: 90 Min
This training program will elucidate effective documentation techniques. It will discuss what documentation is needed to justify a termination decision and key record retention requirements. Attendees will learn how to fill out a performance appraisal and understand the essentials of a document retention program.
CD/Recorded
$249
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Recorded/CD
Implementing a Modern Pharmaceutical Quality System

Implementing a Modern Pharmaceutical Quality System

  • Speaker: Steven Laurenz
  • Product ID: 705055
  • Duration: 60 Min
This presentation explores the basic concepts making up an ICH Q10 Quality System approach and steps to properly implement the concepts.
CD/Recorded
$0
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Recorded/CD
Business Email Compromise and Ransomware - Red Flags and Mitigation

Business Email Compromise and Ransomware - Red Flags and Mitigation

  • Speaker: Rayleen M Pirnie
  • Product ID: 705038
  • Duration: 60 Min
The Internet Crime Complaint Center (IC3) reports that U.S. victims alone lost $18 million in 15 months to just a single form of ransomware. This training program will review the risks associated with various types of cyber fraud, and in particular, business email compromise (BEC) and ransomware. The session will also discuss documenting sound business practices to minimize exposure and loss and list what to present to your board of directors before an incident.
CD/Recorded
$179
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Recorded/CD
Importing into the United States in Compliance with U.S. Customs & Border Protection (CBP)

Importing into the United States in Compliance with U.S. Customs & Border Protection (CBP)

  • Speaker: Jennifer Diaz
  • Product ID: 702212
  • Duration: 60 Min
This U.S. Customs & Border Protection (CBP) compliance training will help you understand best practices when importing products into the U.S.
CD/Recorded
$50
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Recorded/CD
Overview of Penalties for Different OSHA Violations in 2017

Overview of Penalties for Different OSHA Violations in 2017

  • Speaker: Michael Aust
  • Product ID: 704965
  • Duration: 60 Min
This training program addresses the increase in OSHA penalties. The new penalties took effect August 2, 2016. Any citations issued by OSHA on or after this date will be subject to the new penalties if the related violations occurred after November 2, 2015.
CD/Recorded
$0
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Recorded/CD
Introduction to Country of Origin

Introduction to Country of Origin

  • Speaker: Randi Waltuck Barnett
  • Product ID: 704193
  • Duration: 90 Min
This training program will discuss the historical background, legal framework, and overall concepts of origin. It will also highlight the difference between non-preferential and preferential origin and guide attendees in making origin determinations for imports and exports.
CD/Recorded
$149
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Recorded/CD
US Controls on Exports Abroad and Re-Exports: Understand the Regulatory and Administrative Concerns

US Controls on Exports Abroad and Re-Exports: Understand the Regulatory and Administrative Concerns

  • Speaker: Matilda Vasquez
  • Product ID: 705010
  • Duration: 60 Min
This training program will offer an overview of the Foreign Trade Regulations, the 10 General Prohibitions of the Export Administration Regulations, Office of Foreign Assets Controls and the International Traffic in Arms Regulations. It will also offer insight into exports abroad, transshipment and re-export regulations and practices.
CD/Recorded
$179
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Recorded/CD
US Export Filing Requirements and the Proper Use of EAR 99

US Export Filing Requirements and the Proper Use of EAR 99

  • Speaker: Grant Smith
  • Product ID: 705004
  • Duration: 60 Min
Exports are governed by the Bureau of Industry and Security (BIS), under the US Department of Commerce. Exports are regulated by the type of export, the value of the export, and the destination of the export. These factors will help determine the documents needed, and the filings needed to legally export. This webinar training will cover US export filing requirements and the proper use of EAR 99. Failure to follow requirements can result in costly customs holds and or fines/penalties.
CD/Recorded
$0
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