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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
CDISC Mapping 2: ODM, MindMaps and References

CDISC Mapping 2: ODM, MindMaps and References

  • Speaker: Sunil Gupta
  • Product ID: 704208
  • Duration: 90 Min
This training program will highlight key differences between SDTM and ADaM models and process flows. It will also focus on key differences between the seven CDISC classes and on best practices to create Dataset.XML from SAS. Attendees will gain a better understanding of the structure and syntax of ODM-XML files as well.
CD/Recorded
$299
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Recorded/CD
Risk Based Monitoring for GCP Compliance

Risk Based Monitoring for GCP Compliance

  • Speaker: Laura Brown
  • Product ID: 705052
  • Duration: 60 Min
This Webinar will help you how to ensure that your data and supporting documentation are in the appropriate format to comply with regulatory authority inspection. Risk based monitoring can contribute to better oversight and more efficient use of resources of clinical studies.
CD/Recorded
$299
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Recorded/CD
BSA/AML - What is Old is New Again?

BSA/AML - What is Old is New Again?

  • Speaker: Armen Khachadourian
  • Product ID: 703352
  • Duration: 90 Min
This webinar will provide attendees a clear understanding of the compliance department of the future. Attendees will learn the best practices to ensure BSA and AML compliance and avoid failure and fines.
CD/Recorded
$249
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Recorded/CD
2-hr Virtual Seminar: Learning the OSHA Recordkeeping Analysis

2-hr Virtual Seminar: Learning the OSHA Recordkeeping Analysis

  • Speaker: William Principe
  • Product ID: 703267
  • Duration: 120 Min
This 2-hr virtual seminar will show how OSHA analyzes record-keeping scenarios, applying the recordkeeping regulations, Frequently Asked Questions, and Interpretation Letters.
CD/Recorded
$199
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Recorded/CD
The Workers’ Compensation Premium Audit: More than 75% are Incorrect - How You Can Avoid Being Overcharged

The Workers’ Compensation Premium Audit: More than 75% are Incorrect - How You Can Avoid Being Overcharged

  • Speaker: Kevin Ring
  • Product ID: 704448
  • Duration: 60 Min
The webinar will cover what employers need to know about the workers’ compensation premium audit. Experience shows that more than 75 percent of premium audits are incorrect, most often to the detriment of the employer. At the end of the webinar, attendees will be armed with the knowledge they need to ensure that they pay only what exactly they owe for their workers’ compensation and not a penny more.
CD/Recorded
$249
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Recorded/CD
FDA Regulations for Marketing OTC Drugs and New Legislation

FDA Regulations for Marketing OTC Drugs and New Legislation

  • Speaker: Norma Skolnik
  • Product ID: 704145
  • Duration: 60 Min
This training program will illustrate why it’s essential to understand FDA regulations and OTC labeling requirements to market OTC drugs in the U.S.
CD/Recorded
$249
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Recorded/CD
Risk Analysis in Medical Device Design

Risk Analysis in Medical Device Design

  • Speaker: Charles H Paul
  • Product ID: 704803
  • Duration: 60 Min
This webinar will discuss the regulatory requirements and the processes, tools and techniques for conducting an effective risk and hazard analysis for medical devices as per FDA, FTA, FMEA, and FMECA guidelines.
CD/Recorded
$0
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Recorded/CD
The Most Serious FDA 483s - How to Avoid Them

The Most Serious FDA 483s - How to Avoid Them

  • Speaker: John E Lincoln
  • Product ID: 702766
  • Duration: 90 Min
This webinar on avoiding serious FDA 483s will explain FDA's changed audit focus based on recent top 483 findings and provide practical tips on how to better prepare your company's internal audit program to avoid serious Form 483 observations.
CD/Recorded
$299
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Recorded/CD
CMS Restraint and Seclusion (Most Problematic Standard for Hospitals and 2019 Change)

CMS Restraint and Seclusion (Most Problematic Standard for Hospitals and 2019 Change)

  • Speaker: Sue Dill Calloway
  • Product ID: 705145
  • Duration: 120 Min
This program will discuss the most problematic standards in the restraint section. It will cover the 50 pages of restraints standards that hospitals must follow according to CMS.
CD/Recorded
$349
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Recorded/CD
Form W-4 for 2019: Best Practice and Compliance Requirements

Form W-4 for 2019: Best Practice and Compliance Requirements

  • Speaker: Vicki M. Lambert
  • Product ID: 703858
  • Duration: 90 Min
This webinar covers the IRS Form W-4 for 2019 including the requirements for completing the form properly, handling non-resident aliens, state equivalent forms, record retention and processing the form electronically instead of on paper. We also cover the changes to the 2019 form caused by the Tax Cuts and Jobs Act and give information on the related anticipated changes to Form W-4 for 2020. We will also discuss best practices for processing more efficiently within the department.
CD/Recorded
$249
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Recorded/CD
Failure Modes and Effects Analysis - An effective Risk Management Tool

Failure Modes and Effects Analysis - An effective Risk Management Tool

  • Speaker: John Chapman
  • Product ID: 701138
  • Duration: 60 Min
This Medical device training will acquaint one with the various terms used in risk management and the importance of ISO 14971 & ISO 13485 in the managements of risks during the life cycle of medical devices starting with design and manufacture.
CD/Recorded
$299
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Recorded/CD
Laboratory Inspection Readiness - Implementing GMPs for the Pharmaceutical Laboratory

Laboratory Inspection Readiness - Implementing GMPs for the Pharmaceutical Laboratory

  • Speaker: Gregory Martin
  • Product ID: 702534
  • Duration: 90 Min
This 2-hr laboratory inspection webinar will discuss strategies to implement before your laboratory is about to undergo a pre-approval inspection or a general GMP inspection. It will help you gain an understanding of the key areas that are likely to be the subject of a laboratory inspection.
CD/Recorded
$219
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Recorded/CD
FDA Regulations for Environmental Monitoring (EM) Program

FDA Regulations for Environmental Monitoring (EM) Program

  • Speaker: Joy McElroy
  • Product ID: 704377
  • Duration: 90 Min
This training program on applicable regulations pertaining to clean room environmental monitoring (EM) programs will discuss the basics of setting a robust and effective EM program. The course will also detail the relationship between an EM Excursion Program and CAPA and the four phases of clean room transitional monitoring.
CD/Recorded
$299
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Recorded/CD
Grievances and Complaints: What Hospitals Should Know about the CMS, Joint Commission, DNV and OCR Standards?

Grievances and Complaints: What Hospitals Should Know about the CMS, Joint Commission, DNV and OCR Standards?

  • Speaker: Sue Dill Calloway
  • Product ID: 705231
  • Duration: 120 Min
This training program will discuss in detail the CMS requirements for hospitals to help prevent the hospital from being found out of compliance with the grievance regulations. It will also cover a new law under the OCR Section 1557 which requires the hospital to have a new process for handling discrimination complaints.
CD/Recorded
$279
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Recorded/CD
Current Concepts and Challenges in Cloud Compliance

Current Concepts and Challenges in Cloud Compliance

  • Speaker: Angela Bazigos
  • Product ID: 703739
  • Duration: 90 Min
Cloud computing has become perhaps the most critical compliance topic related to computer validation and electronic records. The potential economic and resource advantages to using cloud based environments guarantee that management will expect compliance strategies to be developed that will support decisions to utilize cloud environments to perform regulated activities. This presentation will provide a baseline of information related to cloud computing which will help attendees better understand the cloud concept, associated regulatory challenges, and suggestions for consideration when establishing a cloud based system.
CD/Recorded
$299
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Recorded/CD
3-Hr Virtual Seminar: Import and Export with Latin America: Argentina, Brazil and Venezuela

3-Hr Virtual Seminar: Import and Export with Latin America: Argentina, Brazil and Venezuela

  • Speaker: Raymond Sullivan
  • Product ID: 704646
  • Duration: 3 hrs
This training program on Latin America import and export will detail the US requirements to export and import procedures to Latin America. It will also discuss commercial and customs document requirements, tariffs and applicable duties, countervailing and antidumping duties, and highlight the difference between automatic and non-automatic import licenses.
CD/Recorded
$199
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Recorded/CD
Country of Origin Marking for Imports/Exports

Country of Origin Marking for Imports/Exports

  • Speaker: Jan Seal
  • Product ID: 704785
  • Duration: 90 Min
This training program will focus on regulations that apply to most goods imported into the United States and illustrate them with examples. In addition, attendees will learn more about country of origin marking for exports from the United States to other countries.
CD/Recorded
$199
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Recorded/CD
CDISC Mapping 1: Specifications and FDA Requirements

CDISC Mapping 1: Specifications and FDA Requirements

  • Speaker: Sunil Gupta
  • Product ID: 704152
  • Duration: 90 Min
This training program will discuss CDISC requirements to create SDTMs and ADaMs. It will also offer essential mapping and strategy concepts for creating and validating SDTM and ADaM variables in key CDISC datasets (DM, AE, ADSL, and ADAE).
CD/Recorded
$299
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Recorded/CD
FDA Compliance and Clinical Trial Computer System Validation

FDA Compliance and Clinical Trial Computer System Validation

  • Speaker: Carolyn Troiano
  • Product ID: 705358
  • Duration: 60 Min
This webinar will discuss FDA requirements for clinical trial Computer System Validation (CSV) including System Development Life Cycle (SDLC) approach to validation. It will help attendees understand how to leverage the vendor and other external resources to apply the best industry practices and avoid potential pitfalls when validating a clinical trial system.
CD/Recorded
$199
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Recorded/CD
Bundled Payment Review: How Case Management Can Play a Strategic Role

Bundled Payment Review: How Case Management Can Play a Strategic Role

  • Speaker: Toni Cesta
  • Product ID: 705119
  • Duration: 60 Min
This webinar will teach you how bundled payments actually work as they move from demonstration to reality. It will discuss how case management must become a fully integrated across the continuum model.
CD/Recorded
$249
View Details
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