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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
Drafting 510(k) Submissions Under New FDA Policies - 2012 & Beyond

Drafting 510(k) Submissions Under New FDA Policies - 2012 & Beyond

  • Speaker: Bob Michalik, JD, RAC Michalik
  • Product ID: 702500
  • Duration: 90 Min
This 90-minute 510(K) training will provide practical tips and tools (templates) for preparing regulatory marketing submissions that will ensure swift clearance of your Class II and Class III medical devices.
CD/Recorded
$229
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Recorded/CD
Adjusting your Compliance Program to Meet new FDA Requirements

Adjusting your Compliance Program to Meet new FDA Requirements

  • Speaker: Jason Mefford
  • Product ID: 702509
  • Duration: 60 Min
This webinar will help you understand the new FDA requirements related to the FDA Food Safety Modernization Act (FSMA). You will learn how companies must change their compliance programs in order to meet these new requirements.
CD/Recorded
$229
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Recorded/CD
Effective Use of Validation and Verification to Improve your Food Safety Management System

Effective Use of Validation and Verification to Improve your Food Safety Management System

  • Speaker: John Surak
  • Product ID: 702458
  • Duration: 60 Min
This webinar will cover strategies to effectively use the proper validation and verification techniques to increase the effectiveness of a FSMS. It will show how any food or pharmaceutical company can properly use these techniques to ensure compliance with either ISO 22000 or ISO 9001.
CD/Recorded
$149
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Recorded/CD
When Employer Rights Clash with Employee Privacy Rights

When Employer Rights Clash with Employee Privacy Rights

  • Speaker: Susan Fahey Desmond
  • Product ID: 702472
  • Duration: 60 Min
This webinar will help you identify scenarios and situations where the law protects an individual’s (employee’s) privacy and how an employer can conduct a lawful investigation without crossing the line of violating their employee’s privacy rights.
CD/Recorded
$50
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Recorded/CD
3-hr Virtual Seminar: Human Resources Metrics

3-hr Virtual Seminar: Human Resources Metrics

  • Speaker: Marna Hayden
  • Product ID: 702471
  • Duration: 3 hrs
This 3-hr virtual seminar on logical and meaningful HR metrics will help you in determining what measurements should be used by your company on an ongoing basis and to measure special company goals or initiatives.
CD/Recorded
$299
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Recorded/CD
Supervisors and Their Role in OSHA Compliance and Safety

Supervisors and Their Role in OSHA Compliance and Safety

  • Speaker: Don Dressler
  • Product ID: 702460
  • Duration: 60 Min
This webinar will clarify the role of supervisors under OSHA and provide them with tools to be effective in their jobs and promote safety. You will gain practical and valuable knowledge from the presenter’s extensive experience as an attorney focusing on OSHA compliance.
CD/Recorded
$149
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Recorded/CD
The New HIPAA Audit Protocol - Know What To Do Before They Call

The New HIPAA Audit Protocol - Know What To Do Before They Call

  • Speaker: Jim Sheldon-Dean
  • Product ID: 702456
  • Duration: 90 Min
This 90-minute webinar will explain how HIPAA audits are conducted, what the auditors will look for, what they will ask and how. This training will prepare all HIPAA covered entities and business associates to be fully in compliance and be prepared for an audit at any time and to quickly respond to audits.
CD/Recorded
$229
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Recorded/CD
Complying with Employment Regulations When Religious Beliefs and Work Obligations Conflict

Complying with Employment Regulations When Religious Beliefs and Work Obligations Conflict

  • Speaker: Susan Fahey Desmond
  • Product ID: 702387
  • Duration: 90 Min
This webinar will provide you with a step-by-step guidance on how to deal with complex situations in the workplace that involve conflicts between religious beliefs and work obligations.
CD/Recorded
$149
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Recorded/CD
Risky Business: HACCP Programs for Small Businesses

Risky Business: HACCP Programs for Small Businesses

  • Speaker: David Armatis
  • Product ID: 702423
  • Duration: 60 Min
This webinar will review the first steps of creating a food safety and HACCP program in an on-going operating business. You will understand the key areas to address when setting up or modifying HACCP or food safety programs, with minimal staff.
CD/Recorded
$229
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Recorded/CD
Developing an Effective Industrial Hygiene Monitoring Strategy

Developing an Effective Industrial Hygiene Monitoring Strategy

  • Speaker: Robert Collins
  • Product ID: 702431
  • Duration: 60 Min
This webinar will help you to develop and implement a cost-effective, yet practical strategy, for Industrial Hygiene (IH) monitoring consistent with prevailing standards of practice. You will learn how to select the appropriate sampling and analytical methods for your IH monitoring plan.
CD/Recorded
$149
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Recorded/CD
Understanding and Implementing ISO 17025

Understanding and Implementing ISO 17025

  • Speaker: Dr. Ludwig Huber
  • Product ID: 700989
  • Duration: 75 Min
This webinar will provide a detailed information on the critical requirements of ISO 17025 and recommendations for cost effective implementation. You will learn steps towards laboratory accreditation and how to prepare for an ISO 17025 audit.
CD/Recorded
$50
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Recorded/CD
Developing and Implementing a Practical Noise Monitoring Strategy

Developing and Implementing a Practical Noise Monitoring Strategy

  • Speaker: Robert Collins
  • Product ID: 702414
  • Duration: 65 Min
This webinar will build upon a basic knowledge of noise monitoring and hearing loss to help in understanding the instruments used in performing noise monitoring and how best to use them in developing and implementing a practical strategy for performing noise monitoring.
CD/Recorded
$149
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Recorded/CD
How To Establish An Effective Good Clinical Practice in Drugs and Medical Devices

How To Establish An Effective Good Clinical Practice in Drugs and Medical Devices

  • Speaker: David Lim
  • Product ID: 702252
  • Duration: 90 Min
This 90-minute webinar will help you establish an effective Good Clinical Practice (GCP) by providing a current, accurate and complete (CAC) review and understanding of the relevant and applicable regulations for clinical trials or studies, the requirements and compliance in a systematic, integrative (SI) manner.
CD/Recorded
$229
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Recorded/CD
Making Sense of FDA's (proposed) Rules for the Development and Approval of Biosimilars

Making Sense of FDA's (proposed) Rules for the Development and Approval of Biosimilars

  • Speaker: Karl M. Nobert
  • Product ID: 702325
  • Duration: 60 Min
This webinar will help you understand the process, requirements, quality and safety considerations for demonstrating biosimilarity to a Reference Product. You will learn about what type and how much clinical data are needed to support a showing of biosimilarity.
CD/Recorded
$229
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Recorded/CD
HIPAA and EHRs: How to Comply with the New Regulations and What to Ask of your Vendor

HIPAA and EHRs: How to Comply with the New Regulations and What to Ask of your Vendor

  • Speaker: Jim Sheldon-Dean
  • Product ID: 702258
  • Duration: 90 Min
This 90-minute webinar will review the new and proposed HIPAA Privacy and Security regulations and discuss their effects on the use of Electronic Health Records (EHRs).
CD/Recorded
$229
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Recorded/CD
Software validation and 21 CFR Part 11 remediation planning: FDA inspection strategies

Software validation and 21 CFR Part 11 remediation planning: FDA inspection strategies

  • Speaker: Alfonso Fuller
  • Product ID: 701216
  • Duration: 60 Min
This FDA Inspection training provides concrete strategies for planning remediation projects.
CD/Recorded
$229
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Recorded/CD
Developing and Implementing Golden Parachute Agreements

Developing and Implementing Golden Parachute Agreements

  • Speaker: Michael Melbinger
  • Product ID: 702363
  • Duration: 90 Min
This 90-minute webinar will provide practical tips on how you can develop and implement Golden Parachute Agreements that fulfill tax code and federal securities law requirements, pass investor and media scrutiny, and avoid potentially high stakes litigation.
CD/Recorded
$149
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Recorded/CD
HR Policies for Small Companies/Organizations

HR Policies for Small Companies/Organizations

  • Speaker: Joe Gross
  • Product ID: 702331
  • Duration: 90 Min
This 90-minute webinar provide you a comprehensive understanding of HR policies that small companies need to have, information on the number of employees you can have before you must have these policies in place, and save you from penalties and fines.
CD/Recorded
$149
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Recorded/CD
Risk Management for Human Resources

Risk Management for Human Resources

  • Speaker: Marna Hayden
  • Product ID: 701711
  • Duration: 60 Min
This HR Risk Management training will cover compliance "Hot Spots" where HR professionals need to be especially vigilant in times of complex labor laws, changing environments and workforce reorganization.
CD/Recorded
$199
View Details
Recorded/CD
FDA's Regulation of Veterinary Regenerative Medicine: What Industry Needs to Know to Market and Sell a Stem Cell Product for Use in Dogs, Cats, Horses and other Animals

FDA's Regulation of Veterinary Regenerative Medicine: What Industry Needs to Know to Market and Sell a Stem Cell Product for Use in Dogs, Cats, Horses and other Animals

  • Speaker: Karl M. Nobert
  • Product ID: 702322
  • Duration: 60 Min
This webinar will provide an introduction to FDA’s regulation of veterinary regenerative medicine and highlight the regulatory requirements that a biotech company needs to satisfy to commercialize a stem cell or other complex biotech product for animal use in the U.S.
CD/Recorded
$229
View Details
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