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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
Project Management for Auditors - Improving audit productivity for GCP, GMP and GLP

Project Management for Auditors - Improving audit productivity for GCP, GMP and GLP

  • Speaker: Laura Brown
  • Product ID: 701982
  • Duration: 60 Min
This Project Management training for Auditors will help you understand how to apply project management principles to auditing to ensure efficient and effective quality assurance of drug development.
CD/Recorded
$299
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Recorded/CD
New and Expected Guidance’s on Data Standards and Electronic Submissions for Drugs and Medical Products

New and Expected Guidance’s on Data Standards and Electronic Submissions for Drugs and Medical Products

  • Speaker: Angela Bazigos
  • Product ID: 704529
  • Duration: 90 Min
This training program will examine the approval process for drugs, biologics and devices and elaborate FDA submission requirements and guidances. It will also discuss electronic regulatory submission and gateway for FDA and FDA eCTD guidance and specifications.
CD/Recorded
$249
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Recorded/CD
Best Practices in Nursing Documentation: Writing Effective and Legal Proof Notes

Best Practices in Nursing Documentation: Writing Effective and Legal Proof Notes

  • Speaker: Laura S Hargraves
  • Product ID: 705138
  • Duration: 60 Min
This healthcare documentation webinar will discuss how to create a lawsuit-proof, auditable nursing documentation and how to maintain compliance over the course of the document life-time. You will learn how to de-risk your documentation so as to withstand legal scrutiny.
CD/Recorded
$249
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Recorded/CD
AML Investigations and SAR Preparation

AML Investigations and SAR Preparation

  • Speaker: Armen Khachadourian
  • Product ID: 704406
  • Duration: 90 Min
This training program will provide guidance in recognizing, investigating and reporting suspicious activities. It will also discuss instructions on implementing and maintaining an enterprise wide compliance program to safeguard the financial system from illicit use and combat money laundering and promote national security through the collection, analysis, and dissemination of financial intelligence to the regulatory authorities.
CD/Recorded
$249
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Recorded/CD
FDA Regulations and New Legislation for Marketing Cosmetics in the U.S

FDA Regulations and New Legislation for Marketing Cosmetics in the U.S

  • Speaker: Norma Skolnik
  • Product ID: 704317
  • Duration: 60 Min
The webinar training will cover FDA regulations for marketing cosmetics and help attendees learn about new proposed legislation which will place new requirements on cosmetic product marketing in the U.S.
CD/Recorded
$189
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Recorded/CD
QbD Approach to Analytical Method Lifecycle: Design, Development, Validation and Transfer

QbD Approach to Analytical Method Lifecycle: Design, Development, Validation and Transfer

  • Speaker: Gregory Martin
  • Product ID: 703644
  • Duration: 90 Min
This training on using the QbD approach to analytical method lifecycle is designed to provide participants with a lifecycle approach to developing and validating analytical methods and comply with compendial requirements. The webinar presenter will use case studies to illustrate each stage in the process.
CD/Recorded
$179
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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
$199
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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
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
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
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
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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