ComplianceOnline

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!

Recorded/CD
Trial Master File for Research Sites: Can You Pass FDA Inspection?

Trial Master File for Research Sites: Can You Pass FDA Inspection?

  • Speaker: Madhavi Diwanji
  • Product ID: 701864
  • Duration: 60 Min
This webinar on Trial Master File (TMF) for clinical research sites will show how you can create an FDA compliant TMF to ensure that it will pass inspection by FDA investigators and QA Auditors.
CD/Recorded
$229
Recorded/CD
The U.S. FDA's New Global Engagement Initiative

The U.S. FDA's New Global Engagement Initiative

  • Speaker: John E Lincoln
  • Product ID: 702324
  • Duration: 90 Min
This 90-minute webinar will discuss the new FDA "Global Engagement" Initiative for new areas for heightened CGMP compliance from U. S. FDA-regulated companies and their global partners. It will cover areas for increased awareness, focus, and remediation, and the approaches that are now mandated.
CD/Recorded
$229
Recorded/CD
Common Concerns and Penalties Related to the Americans with Disability Amendments Act (ADAA)

Common Concerns and Penalties Related to the Americans with Disability Amendments Act (ADAA)

  • Speaker: Joe Gross
  • Product ID: 702348
  • Duration: 90 Min
This 90-minute webinar will help you understand the Americans with Disability Amendments Act (ADAA) requirements, concepts, and broad applicability of the Act. It will answer critical questions address common problems that employers face in implementing the ADAA.
CD/Recorded
$149
Recorded/CD
Device Corrections and Removals

Device Corrections and Removals

  • Speaker: Daniel O Leary
  • Product ID: 702291
  • Duration: 90 Min
This 90-minute webinar on device corrections and removals will clarify your obligations for corrections and removals under Part 806 of the FDA regulations.
CD/Recorded
$229
Recorded/CD
21 CFR Part 11 compliance for Electronic Medical Records

21 CFR Part 11 compliance for Electronic Medical Records

  • Speaker: Alfonso Fuller
  • Product ID: 701217
  • Duration: 60 Min
This 21 CFR Part 11 training will analyze the regulations and provides concrete guidance on compliance for Electronic Medical Records.
CD/Recorded
$229
Recorded/CD
HIPAA Breach Notification: Avoiding the fines and costs of healthcare information breaches and what to do when you have a breach

HIPAA Breach Notification: Avoiding the fines and costs of healthcare information breaches and what to do when you have a breach

  • Speaker: Jim Sheldon-Dean
  • Product ID: 702310
  • Duration: 90 Min
This 90-minute webinar on HIPAA Breach Notification will show how to create an effective breach notification policy for your organization and how to follow through when a breach occurs. You will learn about the kinds of threats that exist for PHI, information security methods you can use to keep breaches from happening, and be in compliance with the HIPAA Security Rule as well.
CD/Recorded
$229
Recorded/CD
Best Practices for Maintaining an IND and IDE Application with FDA

Best Practices for Maintaining an IND and IDE Application with FDA

  • Speaker: Mukesh Kumar
  • Product ID: 702254
  • Duration: 60 Min
This webinar on IND and IDE Application management will help you understand the current FDA requirements for IND and IDE application post initial approval to proceed with the clinical trial.
CD/Recorded
$229
Recorded/CD
The Top 6 HIPAA Security Issues: Minimizing Risks Related to Portable Devices, Remote Access, Disaster Recovery, Policies and Procedures, Training, and Documentation

The Top 6 HIPAA Security Issues: Minimizing Risks Related to Portable Devices, Remote Access, Disaster Recovery, Policies and Procedures, Training, and Documentation

  • Speaker: Jim Sheldon-Dean
  • Product ID: 702309
  • Duration: 90 Min
This 90-minute webinar will review the top HIPAA security issues that health information professionals face - encryption and mobile devices, remote access, disaster recovery, policies and procedures, documentation and training - and show what they have to do to mitigate the risks they present.
CD/Recorded
$229
Recorded/CD
21CFR Part 11 - Predicate Rules Compliance

21CFR Part 11 - Predicate Rules Compliance

  • Speaker: Alfonso Fuller
  • Product ID: 701328
  • Duration: 60 Min
This 21CFR Part 11 training will clarify the relationship between predicate rules and 21 CFR part 11 compliance, allowing companies to satisfy FDA with a minimum of effort.
CD/Recorded
$349
Recorded/CD
Handling Supplemental Pay Under the FLSA

Handling Supplemental Pay Under the FLSA

  • Speaker: Michael Haberman
  • Product ID: 702271
  • Duration: 60 Min
This webinar on handling supplemental pay will help you ensure that your supplemental pay practices are in compliance with the Fair Labor Standards Act. It will review in detail all areas of supplemental pay.
CD/Recorded
$199
Recorded/CD
Managing the Risk of Discrimination Litigation with a Compensation Review

Managing the Risk of Discrimination Litigation with a Compensation Review

  • Speaker: Stephanie R Thomas
  • Product ID: 702222
  • Duration: 90 Min
This 90-minute training on managing discrimination litigation risks will provide a comprehensive primer on reviewing compensation systems for internal equity and discuss why, in light of recent legal and regulatory changes, employers should be performing compensation reviews.
CD/Recorded
$149
Recorded/CD
Webinar: When Do You Need a 510K?

Webinar: When Do You Need a 510K?

  • Speaker: Charles R. McConachie
  • Product ID: 702249
  • Duration: 90 Min
This 90-minute webinar will help you understand the 510K process including some history about 510ks versus PMAs and give you the necessary information to know when to file a 510k, as opposed to a PMA, or to not file any 510K of a new or existing medical device.
CD/Recorded
$50
Recorded/CD
3-hr Virtual Seminar - HIPAA Security Policies and Procedures: New finalized regulations bring new obligations

3-hr Virtual Seminar - HIPAA Security Policies and Procedures: New finalized regulations bring new obligations

  • Speaker: Jim Sheldon-Dean
  • Product ID: 702194
  • Duration: 3 hrs
This 3-hr virtual seminar on HIPAA Security Policies and Procedures will show how you can comply with the extensive requirements for policies and procedures in the HIPAA security regulation.
CD/Recorded
$399
Recorded/CD
SSAE 16 (formally known as SAS70), SOC1 to SOC 3 Reporting Demystified

SSAE 16 (formally known as SAS70), SOC1 to SOC 3 Reporting Demystified

  • Speaker: Angela Polania
  • Product ID: 702230
  • Duration: 90 Min
In this 90-minute training you will learn more about SSAE 16 (formally known as SAS 70), SOC 1, SOC 2 and SOC 3 reporting, how to choose the right report for your organization and how to get ready for the attestation.
CD/Recorded
$149
Recorded/CD
3-hr Virtual Seminar - OSHA Asbestos and Mold Awareness: All-in-One Session

3-hr Virtual Seminar - OSHA Asbestos and Mold Awareness: All-in-One Session

  • Speaker: Jonathan Klane
  • Product ID: 702197
  • Duration: 3 hrs
This 3-hr virtual seminar - OSHA Asbestos and Mold Awareness - will cover OSHA's regulations on Asbestos and specific guidelines and general regulations on Mold.
CD/Recorded
$299
Recorded/CD
COBIT and ITIL Framework Alignment to Improve the IT Organization while Improving Compliance

COBIT and ITIL Framework Alignment to Improve the IT Organization while Improving Compliance

  • Speaker: Angela Polania
  • Product ID: 702139
  • Duration: 120 Min
This training will show how the CobIT and ITIL Frameworks can be aligned to enable process maturity analysis, adherence with compliance mandates and process improvement initiatives.
CD/Recorded
$149
Recorded/CD
Preventing Listeria in RTE processing plants

Preventing Listeria in RTE processing plants

  • Speaker: Jeffrey Brusseau
  • Product ID: 702220
  • Duration: 60 Min
This Listeria Prevention training will cover HAACP requisites as well as GMP and Sanitation programs to address areas of possible listeria contamination and methods to eradicate them.
CD/Recorded
$229
Recorded/CD
Implementation of the USP GMP Potency Bioassay Suite

Implementation of the USP GMP Potency Bioassay Suite

  • Speaker: Ana Menendez
  • Product ID: 701275
  • Duration: 60 Min
This webinar on Potency Bioassays will show how to implement the parameters described in the new USP Bioassay suite to deliver compliant assays for Phase I/II, Phase III and commercial products.
CD/Recorded
$299
Recorded/CD
3-hr Virtual Seminar: An Introduction to the FDA New Drug Approval Process

3-hr Virtual Seminar: An Introduction to the FDA New Drug Approval Process

  • Speaker: Karl M. Nobert
  • Product ID: 702207
  • Duration: 3 hrs
This 3-hr virtual seminar on the FDA New Drug Approval Process will cover the NDA and ANDA review and approval process including a discussion of preparing NDAs and ANDAs, relevant meetings, timing, costs, approval requirements and other FDA regulatory requirements. The various existing regulatory approval pathways (the “full” NDA, the 505(b)(2) NDA and the ANDA) will be discussed.
CD/Recorded
$899
Recorded/CD
3-hr Virtual Seminar - OSHA Subpart Z (or IH) Regulations: Everything you Always Wanted to Know About It

3-hr Virtual Seminar - OSHA Subpart Z (or IH) Regulations: Everything you Always Wanted to Know About It

  • Speaker: Jonathan Klane
  • Product ID: 702196
  • Duration: 3 hrs
This 3-hr virtual seminar on OSHA Subpart Z (or IH) Regulations will discuss many of the individual standards as well as the general model and approach and “template” that OSHA takes with these IH regulations.
CD/Recorded
$699
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