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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
Risk-Based Monitoring Beyond the RACT

Risk-Based Monitoring Beyond the RACT

  • Speaker: Beat Widler
  • Product ID: 704721
  • Duration: 60 Min
This training program will explain what the strengths and weaknesses of the RACT are and where it should be used with caution. It will also elaborate on what needs to be done to establish a comprehensive risk management approach to support risk-based quality management in clinical trials.
CD/Recorded
$0
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Recorded/CD
Designing Effective Controls, Security Safeguards and Governance by a Risk-Based Methodology

Designing Effective Controls, Security Safeguards and Governance by a Risk-Based Methodology

  • Speaker: Javier Kuong
  • Product ID: 704656
  • Duration: 120 Min
This training program will provide a practical and structured methodology for the design of governance, controls and security provisions. The methodology can be applied to participants’ real work environment immediately. Participants will also benefit from comparing their present governance and controls design practices with the structured, risk-based methodology presented in the webinar.
CD/Recorded
$0
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Recorded/CD
FMLA, ADA & Workers Comp - Crafting Policies and Procedures for Managing Employee Leave

FMLA, ADA & Workers Comp - Crafting Policies and Procedures for Managing Employee Leave

  • Speaker: Janette Levey Frisch
  • Product ID: 704425
  • Duration: 90 Min
This webinar will decrypt the complexity of FMLA, ADA, workers comp & state employee leave laws. Participants will learn the critical components, difference and laws governing them in order to craft effective leave policies and manage leave abuse.
CD/Recorded
$149
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Recorded/CD
Patient Access of Records under HIPAA - New HHS Guidance, New Focus for HIPAA Audits

Patient Access of Records under HIPAA - New HHS Guidance, New Focus for HIPAA Audits

  • Speaker: Jim Sheldon-Dean
  • Product ID: 704757
  • Duration: 90 Min
This training program will help health information professionals understand what they have to do, and when, and what to keep in mind as they move forward, in order to be in compliance with the new HHS guidance. It will provide a comprehensive look at the guidance and the changes in the HIPAA rules on access and prepare attendees for the process of incorporating the guidance and the changes in how they do business in their facilities.
CD/Recorded
$179
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Recorded/CD
Navigating Standard 1.2.7 - The Regulation of Nutrition and Health Claims in Australia/NZ

Navigating Standard 1.2.7 - The Regulation of Nutrition and Health Claims in Australia/NZ

  • Speaker: Janine Curll
  • Product ID: 704692
  • Duration: 90 Min
This training program will discuss what is a NCC (Nutrition Content Claims), a GLHC (General Level Health Claims), a HLHC (High Level Health Claims), and the conditions for making these claims. Attendees will understand the conditions on the types of foods that can carry nutrition content and health claims and the process to self–substantiate a food health relationship and requirements for FSANZ notification.
CD/Recorded
$199
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Recorded/CD
ISO 14001:2015 - Understanding Documenting and Auditing - Module 3

ISO 14001:2015 - Understanding Documenting and Auditing - Module 3

  • Speaker: Michael Aust
  • Product ID: 704748
  • Duration: 60 Min
This final training program in the series will help identify how the environment impacts your organization under the new ISO 14001:2015 standard. It will detail how to properly develop an audit schedule and plan for internal and external audits. The session will also describe the next steps to get compliant with the new standard, while preparing for audit and proper documentation.
CD/Recorded
$0
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Recorded/CD
ICD-10 Other Factors Affecting Revenue

ICD-10 Other Factors Affecting Revenue

  • Speaker: Dorothy Steed
  • Product ID: 704746
  • Duration: 60 Min
If you are experiencing claims problems, reduced revenue, increased requests for medical records, or receiving payer push back about you’re coding and billing quality, this training program is for you. All these areas will be discussed in the webinar.
CD/Recorded
$0
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Recorded/CD
FDA's Medical Device Software Regulation

FDA's Medical Device Software Regulation

  • Speaker: Casper Uldriks
  • Product ID: 704749
  • Duration: 90 Min
This training program will focus on FDA software guidance. It will elaborate on applying current provisions that NIST (National Institute of Science and Technology) has put forth in recent reports that FDA will integrate into its regulatory oversight as well.
CD/Recorded
$169
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Recorded/CD
When Studies are Exempted from IND Requirements: Understanding the Criteria and the Consequences

When Studies are Exempted from IND Requirements: Understanding the Criteria and the Consequences

  • Speaker: Jennifer Holcomb
  • Product ID: 702345
  • Duration: 60 Min
This Clinical compliance training will review the purpose of INDs and the process for obtaining an IND. Attendees will gain a complete understanding of the criteria for exemption and the impact an exemption has on a study.
CD/Recorded
$229
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Recorded/CD
3-Hr Virtual Training: What to Expect in a Federal HIPAA Audit and How to Avoid an Audit Altogether

3-Hr Virtual Training: What to Expect in a Federal HIPAA Audit and How to Avoid an Audit Altogether

  • Speaker: Brian Tuttle
  • Product ID: 704761
  • Duration: 3 hrs
This webinar training will discuss changes with the Health and Human Services in regards to the enforcement of the HIPAA laws already on the books and new risks specific to business associates. It will also discuss factors that might cause an unwanted visit or letter from the Office of Civil Rights and how to prepare for the audit and deal with federal and state laws.
CD/Recorded
$0
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Recorded/CD
3-hr Virtual Seminar - Trade with Southern Hemisphere: DR-CAFTA (Dominican Republic-Central America)

3-hr Virtual Seminar - Trade with Southern Hemisphere: DR-CAFTA (Dominican Republic-Central America)

  • Speaker: Linda B Sarabia
  • Product ID: 704715
  • Duration: 3 hrs
This training program on CAFTA import and export will detail the US requirements to export and import procedures to CAFTA Nations. It will also discuss commercial and customs document requirements, tariffs and applicable duties, countervailing and antidumping duties, and highlight the difference and interaction between CAFTA and NAFTA.
CD/Recorded
$0
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Recorded/CD
Social Networks and Pharmacovigilance: What Will Change?

Social Networks and Pharmacovigilance: What Will Change?

  • Speaker: Marco Anelli
  • Product ID: 704690
  • Duration: 90 Min
This training program will examine the different types of social networks (Facebook, Twitter, etc.) and help identify similarities, differences, and challenges for pharmacovigilance (PV) professionals. It will also analyze social networks and the new approach to benefit/risk ratio.
CD/Recorded
$0
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Recorded/CD
Structuring and Implementing Hospital-Physician Medical Director and Administrative Arrangements: Key Legal Considerations for Health Systems, Hospitals and Medical Groups - Part I

Structuring and Implementing Hospital-Physician Medical Director and Administrative Arrangements: Key Legal Considerations for Health Systems, Hospitals and Medical Groups - Part I

  • Speaker: Joseph Wolfe
  • Product ID: 704742
  • Duration: 60 Min
Given the substantial awards and settlements in recent enforcement actions, Stark Law compliance has become more than just a compliance issue: it is an enterprise risk management issue. As medical groups, hospitals, and health systems transition to more innovative compensation structures, this training program will focus on managing compliance and enterprise risk by ensuring their medical director and administrative arrangements are defensible under the Stark Law.
CD/Recorded
$179
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Recorded/CD
Dos & Don'ts Related to Information Security and Data Privacy

Dos & Don'ts Related to Information Security and Data Privacy

  • Speaker: Marc Perl
  • Product ID: 704736
  • Duration: 60 Min
This training program will prepare your organization to understand the need for data security, the steps that can be taken to institute or augment your data security policies/procedures, and the implementation of the needed controls. This webinar will introduce attendees to a set of known and respected data security standards that can be employed by your organization to improve your security. Attendees will walk away with ideas to leverage the curriculum with their existing security infrastructure.
CD/Recorded
$249
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Recorded/CD
Sterilizing Grade and Prefilter

Sterilizing Grade and Prefilter

  • Speaker: Mark Trotter
  • Product ID: 704703
  • Duration: 90 Min
This training program will review the latest industry filtration technologies and standards with an overview of regulatory requirements. It will also discuss why and how to determine which filter, the media, and pore ratings that are appropriate for various filtration applications. The program is designed for experienced as well as those new to biopharmaceutical processes. The need-to-know current requirements for specifying sterilizing grade and prefilters in biopharm processes will also be discussed.
CD/Recorded
$0
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Recorded/CD
FDA Pre-Approval Inspection Readiness: Actionable Steps to Prepare for a BIMO Inspection

FDA Pre-Approval Inspection Readiness: Actionable Steps to Prepare for a BIMO Inspection

  • Speaker: Nicole Tesar
  • Product ID: 704640
  • Duration: 60 Min
This 60-minute training program is designed for those working in the field of clinical research either as a sponsor (pharmaceutical/biotech company) or a research site. The session will discuss key FDA inspection terminology, types of BIMO inspections, site inspection procedures, and sponsor inspection procedures. Attendees will understand when an inspection is likely to be scheduled and the current trends in findings.
CD/Recorded
$0
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Recorded/CD
Hazwoper Training: Tips to Hazardous Waste Cleanup per OSHA’s Guidance

Hazwoper Training: Tips to Hazardous Waste Cleanup per OSHA’s Guidance

  • Speaker: Sheldon Primus
  • Product ID: 704602
  • Duration: 60 Min
This training program will focus on helping attendees identify the hazards of chemical spill cleanup, understand the steps to properly clean up hazardous chemical spills, and gain a basic knowledge of the Resource Conservation and Recovery Act and Process Safety Management.
CD/Recorded
$0
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Recorded/CD
How to Write Error Free and FDA Compliant Procedures

How to Write Error Free and FDA Compliant Procedures

  • Speaker: Ginette M Collazo
  • Product ID: 704122
  • Duration: 90 Min
This training program will focus on the importance of procedures. Attendees will learn why people avoid procedures and understand common human errors and deviations related to the use of procedures.
CD/Recorded
$179
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Recorded/CD
ISO 14001:2015 - Advanced Overview - Module 2

ISO 14001:2015 - Advanced Overview - Module 2

  • Speaker: Michael Aust
  • Product ID: 704728
  • Duration: 60 Min
ISO 14001 is the world's best-known environmental management system standard, and it provides a systematic framework to help organizations protect the environment through balanced socio-economic means. This training program in the two-part series will offer an advanced overview of ISO 14001:2015 and what the updates mean for your business.
CD/Recorded
$0
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Recorded/CD
How to Bill Medicare for Durable Medical Equipment and Stay Legally Compliant

How to Bill Medicare for Durable Medical Equipment and Stay Legally Compliant

  • Speaker: Gregory J Simms
  • Product ID: 702134
  • Duration: 60 Min
This training program will expound on how treating your Medicare patients with durable medical equipment (DME) can be great for patient clinical outcomes, a great revenue stream, and can be legally compliant. It will also lower healthcare costs. However, one must know how to get the proper licensure and know the federal and state guidelines.
CD/Recorded
$50
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