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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
CMC Considerations for INDs and NDAs for 505(b)(2) Products

CMC Considerations for INDs and NDAs for 505(b)(2) Products

  • Speaker: Mukesh Kumar
  • Product ID: 703393
  • Duration: 90 Min
This webinar will highlight the key elements of the Chemistry, Manufacturing and Controls (CMC) section of an IND and NDA application for a 505(b)(2) product using examples and case studies. It will also discuss role of Drug Master Files (DMFs), and cross reference authorizations.
CD/Recorded
$229
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Recorded/CD
CFR 21 Part 11 and Annex 11: How to Avoid the Audit Traps

CFR 21 Part 11 and Annex 11: How to Avoid the Audit Traps

  • Speaker: Chinmoy Roy
  • Product ID: 702279
  • Duration: 75 Min
This webinar on Part 11/Annex 11 audit and enforcement will explain what the auditors are trained to look for during a Part 11/Annex 11 “tag along” audit. It will cover inspection trends with examples of some recent 483s and warning letters and show what one need to do to have a successful inspection outcome.
CD/Recorded
$229
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Recorded/CD
Overview of Importing Foreign Cosmetic and OTC Products

Overview of Importing Foreign Cosmetic and OTC Products

  • Speaker: Marc Sanchez
  • Product ID: 703379
  • Duration: 60 Min
This webinar will cover key definitions like cosmetics, new drugs, adulteration and misbranding, including key concepts like color additive restrictions and labeling requirements. Attendees will learn best practices for responding to Warning Letters.
CD/Recorded
$229
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Recorded/CD
Document Approval, Control, and Distribution: How to Meet FDA QSR and ISO 13485 Requirements

Document Approval, Control, and Distribution: How to Meet FDA QSR and ISO 13485 Requirements

  • Speaker: Jeff Kasoff
  • Product ID: 700254
  • Duration: 60 Min
This presentation will review the QSR and ISO requirements for document control, and provide a streamlined process for document control.
CD/Recorded
$229
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Recorded/CD
How to Conduct an FLSA Classification Self-Audit

How to Conduct an FLSA Classification Self-Audit

  • Speaker: Max Muller
  • Product ID: 703388
  • Duration: 60 Min
This webinar will explain how to undertake a voluntary self-audit of your organization’s pay practices. Attendees will learn how to determine who is exempt from the overtime provisions of the FLSA and how to document classification decisions.
CD/Recorded
$149
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Recorded/CD
Successful Steps in Documenting Unsatisfactory Employee Performance

Successful Steps in Documenting Unsatisfactory Employee Performance

  • Speaker: Glenn Harris
  • Product ID: 703385
  • Duration: 75 Min
This webinar will explain key steps in documenting employee unsatisfactory performance and progressive employee discipline. Attendees will learn how to clearly and effectively communicate to employees desired behavior and provide specific directives for employee improvement.
CD/Recorded
$50
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Recorded/CD
FDA Regulatory Actions: It's Not Just about Warning Letters

FDA Regulatory Actions: It's Not Just about Warning Letters

  • Speaker: Fredric Richman
  • Product ID: 703344
  • Duration: 60 Min
This training will outline the possible consequences for failing to promptly and adequately correct significant violations related to cGMPs, new drugs or devices, labeling or other regulatory issues resulting in advisory, administrative and judicial actions.
CD/Recorded
$229
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Recorded/CD
FDA Premarket Review of New and Modified Tobacco Products

FDA Premarket Review of New and Modified Tobacco Products

  • Speaker: Azim Chowdhury
  • Product ID: 703127
  • Duration: 60 Min
This training on FDA regulatory requirements for tobacco products will focus on the premarket review of new and modified tobacco products. It will also discuss the impact of FDA deeming regulation for of e- cigarettes and novel tobacco products on premarket authorization requirements.
CD/Recorded
$229
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Recorded/CD
New HIPAA Rules, Tools, and Guidance - Latest Changes and What to Expect Next

New HIPAA Rules, Tools, and Guidance - Latest Changes and What to Expect Next

  • Speaker: Jim Sheldon-Dean
  • Product ID: 703370
  • Duration: 90 Min
This HIPAA compliance training will focus on the privacy and security policies and Notices of Privacy Practices that must be updated to ensure compliance with the final HIPAA Omnibus rule. It will also discuss the new recommendations for accounting of disclosures regulations and the HIPAA audit program.
CD/Recorded
$149
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Recorded/CD
How to file a 510(k) when your device is (or contains) software

How to file a 510(k) when your device is (or contains) software

  • Speaker: Cheryl Wagoner
  • Product ID: 703366
  • Duration: 75 Min
The Webinar will discuss the structure and level of detail required in filing a 510(k) when a medical device is software or contains software.
CD/Recorded
$299
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Recorded/CD
The Two Midnight Rule - Guidance, status and key steps on implementation to avoid enforcement difficulties

The Two Midnight Rule - Guidance, status and key steps on implementation to avoid enforcement difficulties

  • Speaker: Susan Lee Walberg
  • Product ID: 703362
  • Duration: 60 Min
This healthcare webinar will provide the latest guidance and status on implementation and enforcement of the ‘Two-Midnight Rule’, which is a part of the CMS' IPPS 2014 regulations. It will also provide guidance on key steps to implement in order to avoid enforcement difficulties down the road.
CD/Recorded
$229
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Recorded/CD
Employee Final Settlements: What You Can Do To Achieve Final Finality

Employee Final Settlements: What You Can Do To Achieve Final Finality

  • Speaker: Jonathan Evan Goldberg
  • Product ID: 703298
  • Duration: 60 Min
This webinar will focus on techniques and strategies for negotiating employment dispute settlements. Attendees will learn best practices for ensuring finality.
CD/Recorded
$50
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Recorded/CD
How to Create Legally Compliant Commission Agreements

How to Create Legally Compliant Commission Agreements

  • Speaker: Stephanie Yang
  • Product ID: 703343
  • Duration: 60 Min
This webinar will focus on the requirements of a commission agreement in California and differences between an earned commission and an unearned commission. Attendees will learn best practices for creating commission agreements for California employees and how to avoid the pitfalls.
CD/Recorded
$149
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Recorded/CD
Food Safety and Continual Improvement: Beyond Corrections and Audits

Food Safety and Continual Improvement: Beyond Corrections and Audits

  • Speaker: Oscar Rodriguez Gonzalez
  • Product ID: 703361
  • Duration: 60 Min
This webinar will present a proactive approach to improve food safety management systems that go beyond corrective actions to deviations and findings from external audits. It will focus on the continual improvement methodologies to speed up or optimize processes, solve problems and manage complexity.
CD/Recorded
$229
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Recorded/CD
Managing the Trial Master File - Considerations for Moving to Electronic TMFs

Managing the Trial Master File - Considerations for Moving to Electronic TMFs

  • Speaker: Eldin Rammell
  • Product ID: 703256
  • Duration: 60 Min
This clinical compliance training will review what issues one needs to consider if one’s organization is thinking about introducing an IT solution for the management of trial master file content. Attendees will gain an understanding of how to comply with the regulatory requirements that are pertinent to the maintenance of the TMF and how to choose efficient supporting TMF processes.
CD/Recorded
$229
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Recorded/CD
Mobile Medical Applications: Software Regulatory Requirements

Mobile Medical Applications: Software Regulatory Requirements

  • Speaker: Tim Stein
  • Product ID: 702812
  • Duration: 90 Min
This mobile medical apps training will outline the regulatory requirements for medical device software development processes, and the requirements for submissions.
CD/Recorded
$349
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Recorded/CD
Supplier Quality Management: Implement it Now or Pay for it Later

Supplier Quality Management: Implement it Now or Pay for it Later

  • Speaker: Les Schnoll
  • Product ID: 703357
  • Duration: 90 Min
This webinar will discuss FDA's requirements for medical device supplier management and the controls you need to have in place to ensure compliance with quality. It will cover how to structure a supplier quality agreement and the tools and methods you need for evaluating and assessing suppliers.
CD/Recorded
$229
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Recorded/CD
Travel Pay and Expense Reimbursements - Do You Comply with the Law?

Travel Pay and Expense Reimbursements - Do You Comply with the Law?

  • Speaker: Miles Hutchinson
  • Product ID: 703342
  • Duration: 90 Min
This webinar will explain various laws affecting travel pay and expense reimbursements. Attendees will learn best practices to comply with federal travel regulations.
CD/Recorded
$149
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Recorded/CD
Are you prepared for a regulatory audit from FDA or any other regulatory body?

Are you prepared for a regulatory audit from FDA or any other regulatory body?

  • Speaker: Philip Russ
  • Product ID: 703355
  • Duration: 90 Min
This FDA audit training provides an overview of the audit readiness process from internal evaluation of your quality systems to the logistics of the audit itself; with key emphasis placed on equipping you and your team with the skills needed to present expert testimony during interviews with regulators.
CD/Recorded
$229
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Recorded/CD
Conducting a Risk Analysis to Comply with Meaningful Use, HIPAA and HITECH

Conducting a Risk Analysis to Comply with Meaningful Use, HIPAA and HITECH

  • Speaker: William Miaoulis
  • Product ID: 703347
  • Duration: 90 Min
This webinar will discuss how to do a security risk analysis to meet the requirements of HIPAA, HITECH and Meaningful Use attestation. It will describe ways for effectively completing a risk analysis at the organizational level, the network level and the application level.
CD/Recorded
$229
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