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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
Integration of ERP and Legacy FDA-Regulated Systems

Integration of ERP and Legacy FDA-Regulated Systems

  • Speaker: Carolyn Troiano
  • Product ID: 704547
  • Duration: 60 Min
This training program will assist those responsible for planning, executing or managing the integration of a business system with any laboratory system governed by FDA regulations. On completing the program, attendees will have an understanding of laboratory system computer validation planning, execution and management concepts, and how they apply to any integrated business system.
CD/Recorded
$0
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Recorded/CD
Affirmative Action Trends and Compliance Advice | New Labor Rules and OFCCP Regulations

Affirmative Action Trends and Compliance Advice | New Labor Rules and OFCCP Regulations

  • Speaker: Cathleen M. Hampton
  • Product ID: 704541
  • Duration: 90 Min
This webinar was designed to provide human resource professionals and business executives with the practical information they need to help increase their effectiveness when developing Affirmative Action programs and practices. Participants will learn about the new labor rules and OFCCP’s regulations in regards to AAP.
CD/Recorded
$149
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Recorded/CD
How to Survive a DEA Inspection Series - DEA and Veterinary Medicine

How to Survive a DEA Inspection Series - DEA and Veterinary Medicine

  • Speaker: Carlos M Aquino
  • Product ID: 704563
  • Duration: 60 Min
This training program is tailored for practitioners treating pain. It will provide you with a better understanding of a DEA inspection and the records needed in the event of an inquiry by DEA or any state regulatory agency. Participants will familiarize themselves with the federal laws and regulations enforced by DEA pertaining to Schedules II through V controlled substances that is dispensed, or prescribed by a physician as part of a pain treatment plan.
CD/Recorded
$0
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Recorded/CD
Monitoring for the FSMA Proposed Rule on Intentional Contamination

Monitoring for the FSMA Proposed Rule on Intentional Contamination

  • Speaker: Ned Mitenius
  • Product ID: 704451
  • Duration: 60 Min
The program will discuss the practical development of an adequate monitoring program optimized to fit the Intentional Adulteration Rule. Attendees will learn the difference between monitoring, verification and validation. The program will review the existing Food Defense Plan Builder tool including its limitations and some possible changes. In the absence of a provided tool, the program participants will be shown how to create an effective monitoring program, and the documentation required to support it.
CD/Recorded
$0
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Recorded/CD
What to Expect When Your Employee Is Expecting: Navigating Pregnancy-Related Issues in California Workplaces

What to Expect When Your Employee Is Expecting: Navigating Pregnancy-Related Issues in California Workplaces

  • Speaker: Jacquiline M Wagner
  • Product ID: 704536
  • Duration: 60 Min
This webinar training course will assist California employers navigate the sometimes turbulent waters of successfully addressing and managing the issues afoot when an employee is expecting. The Instructor will share practical methods of evaluating pregnancy accommodation request, ensuring a pregnant employee receives entitled leave and tips for ensuring a smooth return-to-work.
CD/Recorded
$149
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Recorded/CD
HR/Benefits Outsourcing - Return on Investment (ROI)

HR/Benefits Outsourcing - Return on Investment (ROI)

  • Speaker: Rob J Thurston
  • Product ID: 704535
  • Duration: 90 Min
This webinar training will discuss how to identify key areas of HR/ benefit that can be outsourced and to evaluate and find quality outsourcing options. The Instructor will share surveys, case studies and trends in the Industry. Participants will also learn the law of sunk costs and how to do a cost-benefit analysis.
CD/Recorded
$25
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Recorded/CD
Adverse Event Reporting: Site and Sponsor Reporting Requirements for Investigational Products

Adverse Event Reporting: Site and Sponsor Reporting Requirements for Investigational Products

  • Speaker: Nicole Tesar
  • Product ID: 704534
  • Duration: 60 Min
This training program will help attendees understand what adverse events, serious adverse events and unanticipated problems are, and why reporting them is important to a study hypothesis and is key to keeping subjects safe while on a clinical trial. They will also learn the responsibilities of the sponsor, site/clinical investigator and regulatory agency in reporting adverse events.
CD/Recorded
$0
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Recorded/CD
AML, SOX and Licensing Controls Failures - Detection, Prevention and Risk Mitigation Strategies

AML, SOX and Licensing Controls Failures - Detection, Prevention and Risk Mitigation Strategies

  • Speaker: Jim George
  • Product ID: 704527
  • Duration: 60 Min
This webinar will discuss the common AML, SOX and Licensing control failures and how to detect and prevent them. The instructor will discuss the legal impact of non-compliance on banks and financial institutions, red flags and how to strengthen your internal controls to mitigate risk.
CD/Recorded
$0
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Recorded/CD
New OSC / ICE Guidelines on Internal I-9 Audits Concerning I-9 Errors and How to Correct the Errors

New OSC / ICE Guidelines on Internal I-9 Audits Concerning I-9 Errors and How to Correct the Errors

  • Speaker: Bruce Buchanan
  • Product ID: 703847
  • Duration: 90 Min
This webinar training will discuss common I-9 violations, the recent guidance for ICE and OSC internal I-9 audits and new methods offered to correct errors. The instructor will also discuss the ever-expanding actions by the Office of Special Counsel (OSC) for citizenship and national origin discrimination.
CD/Recorded
$249
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Recorded/CD
Applying SAS Program Validation Techniques Using Proc Tabulate to QC Summary Tables

Applying SAS Program Validation Techniques Using Proc Tabulate to QC Summary Tables

  • Speaker: Sunil Gupta
  • Product ID: 704539
  • Duration: 70 Min
This training program is intended for anyone directly or indirectly responsible for the creation, content or validation of SDTMs, ADaMs, tables, and data lists used to support research, drug or medical device efficacy and safety in a regulatory submission. Professionals in the pharmaceutical, biotechnology and medical device industries who want to be 21CFR Part 11 or Good Clinical Practices (GCP) compliant in relation to regulatory submission environment will benefit from this course.
CD/Recorded
$0
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Recorded/CD
Worksheets that Capture SOP Details and Are Compliant

Worksheets that Capture SOP Details and Are Compliant

  • Speaker: Edward O Connor
  • Product ID: 704532
  • Duration: 60 Min
This training program will focus on understanding the drivers and benefit of using worksheets not only as a prompt for recording details but also in reducing efforts of the analysts and auditors in a GLP/GCP bioanalytical lab.
CD/Recorded
$0
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Recorded/CD
CAPA Investigations - Tools for a Compliant and Effective Investigation Process

CAPA Investigations - Tools for a Compliant and Effective Investigation Process

  • Speaker: Carlos Rodriguez Garcia
  • Product ID: 704039
  • Duration: 60 Min
This training program will provide professionals with essential elements of CAPA investigations to assure compliance with regulatory requirements. The corrective and preventive action (CAPA) program is an essential element of a compliant quality management system, as required by international regulations and voluntary standards. Investigations are the backbone of the CAPA program.
CD/Recorded
$229
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Recorded/CD
Family Care and Medical Leave in California - Part II

Family Care and Medical Leave in California - Part II

  • Speaker: Jacquiline M Wagner
  • Product ID: 704508
  • Duration: 90 Min
This series of training programs on Family Care and Medical Leave in California will examine compensation while on leave, continuation of benefits while on leave, employer’s prohibited actions under the CFRA, employee’s return to work policies, and more.
CD/Recorded
$199
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Recorded/CD
Customs Single Window: Are You in Compliance?

Customs Single Window: Are You in Compliance?

  • Speaker: Grant Smith
  • Product ID: 704261
  • Duration: 60 Min
This training program will offer attendees an understanding of single window requirements. It will also discuss documentation requirements (electronic vs. paper) and help determine software requirements.
CD/Recorded
$0
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Recorded/CD
Document Retention: Don’t be Overwhelmed by Your Record Management Program

Document Retention: Don’t be Overwhelmed by Your Record Management Program

  • Speaker: Cathleen M. Hampton
  • Product ID: 704525
  • Duration: 90 Min
This training program will discuss tips for business records retention practices that both strengthen your process and standardize your records management program. The instructor with discuss why effective and reliable records management must be part of your compliance program. The course will also cover key elements of security assessment of your plan, how to plan for worst case scenarios and developing records retention schedules.
CD/Recorded
$149
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Recorded/CD
Cuba Sanctions: All You Need To Know

Cuba Sanctions: All You Need To Know

  • Speaker: Jennifer Diaz
  • Product ID: 704513
  • Duration: 60 Min
In this training program, attendees will learn from an established customs and international trade law expert about recent developments regarding U.S. laws and regulations addressing the expansion of trade, commerce and business opportunities in Cuba.
CD/Recorded
$149
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Recorded/CD
E-Compliance: Online Privacy, Harassment and Identity Theft in the Digital Age

E-Compliance: Online Privacy, Harassment and Identity Theft in the Digital Age

  • Speaker: Joseph Rosner
  • Product ID: 704524
  • Duration: 60 Min
This webinar will discuss the bane of new technology and social media in regards to employers’ and employees’ privacy. The instructor will discuss e-compliances that employers need to adhere to avoid privacy suits. He will also cover the risks of information breach and defamation claims from electronic employee postings. Participants will know how to deal with online privacy and harassment claims and ways and limits of disciplining employees’ online presence. The course will also examine how to legally use Internet postings, profiles and other content in hiring decisions.
CD/Recorded
$0
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Recorded/CD
Discussion of Revisions Contained in ISO 13485:2016

Discussion of Revisions Contained in ISO 13485:2016

  • Speaker: Edward Kimmelman
  • Product ID: 704506
  • Duration: 90 Min
The training program will prepare attendees to better understand the revisions to this standard as they read its requirements in detail. For those organizations that have a QMS that's compliant with ISO 13485:2003, you will benefit from this program as it will help you assess your preparations.
CD/Recorded
$229
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Recorded/CD
Harassment and Bullying: A Sepsis in Healthcare and Detriment to Patient and Staff Safety

Harassment and Bullying: A Sepsis in Healthcare and Detriment to Patient and Staff Safety

  • Speaker: Dr. Susan Strauss
  • Product ID: 704522
  • Duration: 120 Min
Harassment and bullying have become common place in America’s workplaces and particularly in healthcare. As an employer/manager you have the responsibility to both prevent and intervene any abusive conduct and as health professionals to provide quality patient care. This webinar will discuss the two forms of misconduct, what to do when subjected to the harassment or a witness of abusive conduct and how to formulate and implement harassment policy to prevent misconduct.
CD/Recorded
$0
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Recorded/CD
4-Hour Virtual Training: FDA Regulations for Marketing and Labeling OTC Drugs in the U.S.

4-Hour Virtual Training: FDA Regulations for Marketing and Labeling OTC Drugs in the U.S.

  • Speaker: Norma Skolnik
  • Product ID: 704530
  • Duration: 4 hrs
The objective of this virtual training seminar is to assist attendees in understanding and being able to apply FDA regulations for OTC drugs and to label and market them successfully in the U.S. while avoiding regulatory problems. The program will also explore other verticals such as: OTC drug monographs and their importance to product marketing, a summary of OTC drug GMP regulations, FDA rules for adverse event reporting of OTC drugs, avoiding FDA Warning Letters, and more.
CD/Recorded
$0
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