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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
U.S. Adverse Event Reporting Regulations for Drugs, Dietary Supplements and Cosmetics

U.S. Adverse Event Reporting Regulations for Drugs, Dietary Supplements and Cosmetics

  • Speaker: Norma Skolnik
  • Product ID: 704371
  • Duration: 60 Min
In order to market dietary supplements and OTC drugs in the U.S., reporting serious adverse events is required. It’s essential to understand these important FDA requirements to assure regulatory compliance and avoid an FDA warning letter or 483 audit issues.
CD/Recorded
$249
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Recorded/CD
When and How to Report Errors to Customs and Border Protection

When and How to Report Errors to Customs and Border Protection

  • Speaker: Donna L Shira
  • Product ID: 703292
  • Duration: 60 Min
This U.S. Customs & Border Protection compliance (CBP) training will focus on methods that can be used in reporting the errors to the CBP. Attendees will learn best practices for importing products into the U.S to avoid penalties.
CD/Recorded
$149
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Recorded/CD
USA Export Documentation and Procedures

USA Export Documentation and Procedures

  • Speaker: Jan Seal
  • Product ID: 705536
  • Duration: 90 Min
This webinar will assist U.S. companies who export goods around the world to understand the Bureau of Industry and Security U.S. export procedures and regulations and the Foreign Trade Regulations for reporting electronic export information in the Automated Export System (AES) to U.S. Census. It will also assist companies in implementing or updating written export procedures and implementing internal controls to reduce or avoid penalties.
CD/Recorded
$229
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Recorded/CD
Documentation of Medical Necessity - Focus for OIG and other auditors

Documentation of Medical Necessity - Focus for OIG and other auditors

  • Speaker: Laura S Hargraves
  • Product ID: 705139
  • Duration: 60 Min
This medical necessity documentation webinar will cover all the key information needed to support your efforts to document and demonstrate Medical Necessity of services.
CD/Recorded
$249
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Recorded/CD
21 CFR 11 Compliance for Excel Spreadsheet

21 CFR 11 Compliance for Excel Spreadsheet

  • Speaker: Angela Bazigos
  • Product ID: 702450
  • Duration: 90 Min
This Excel spreadsheet compliance training will outline the FDA requirements for Excel spreadsheets used in regulated environments and provide guidance on 21 CFR Part 11 validation.
CD/Recorded
$249
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Recorded/CD
The Dos and Don’ts of Poster Compliance - Is Your Company in Compliance with the 2019 Poster Requirements?

The Dos and Don’ts of Poster Compliance - Is Your Company in Compliance with the 2019 Poster Requirements?

  • Speaker: Margie Pacheco Faulk
  • Product ID: 705233
  • Duration: 90 Min
This training program will equip you with the tools needed to be compliant with workplace labor poster regulations and avoid paying high penalties and fines. It will assist HR, business owners, and professionals responsible for guiding their companies to follow regulations and reduce their risk.
CD/Recorded
$229
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Recorded/CD
Handling Payroll Overpayments Correctly

Handling Payroll Overpayments Correctly

  • Speaker: Vicki M. Lambert
  • Product ID: 703942
  • Duration: 90 Min
This training program will examine the FLSA requirements on recouping overpayments including the 1998 opinion letter that spells out these requirements. It will also focus on issues such as exempt employee status, minimum wage and overtime rules for nonexempt employees must be considered when recovering overpayments from employees. Additionally, it will review the wage and hour laws of several states and the factors that determine if an overpayment can be recouped.
CD/Recorded
$249
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Recorded/CD
USA Import Compliance Program and Written Procedures

USA Import Compliance Program and Written Procedures

  • Speaker: Jan Seal
  • Product ID: 705467
  • Duration: 90 Min
Learn how to pass a focused assessment by the US CBPs Regulatory Audit Division, reduce your risk of non-compliance with import requirements and evaluation of internal controls.
CD/Recorded
$219
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Recorded/CD
Contemporary Case Management Staffing and Models: Best Practices in the Era of Value-Based Purchasing

Contemporary Case Management Staffing and Models: Best Practices in the Era of Value-Based Purchasing

  • Speaker: Toni Cesta
  • Product ID: 705424
  • Duration: 60 Min
This webinar will review contemporary, best practice, case management models including descriptions of the two most commonly used models, the key differences between the models, as well as how they should be designed and structured. The webinar will also discuss the steps needed to re-engineer a case management department and tips for identifying the best model for your organization.
CD/Recorded
$249
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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
Creating a Risk-based Supplier Management program

Creating a Risk-based Supplier Management program

  • Speaker: Betty Lane
  • Product ID: 702501
  • Duration: 75 Min
This webinar on supplier controls will provide you the information you need to assure your supplier management program is in compliance with the latest FDA, European and international guidelines requiring a risk-based supplier management program. We will look at how to improve your supplier management system to meet both the FDA and ISO expectation while potentially reducing your cost of compliance.
CD/Recorded
$299
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Recorded/CD
Multistate Taxation - Fundamentals and Best Practices for Handling Multistate employees

Multistate Taxation - Fundamentals and Best Practices for Handling Multistate employees

  • Speaker: Vicki M. Lambert
  • Product ID: 702984
  • Duration: 90 Min
Attend this webinar to learn payroll best practices (handling of state taxes, wage and hour law, and garnishments) when an employee lives in one state and works in another, or works in two or more states simultaneously. This Includes determining liability as an employer, reciprocal agreements, resident and nonresident taxation, Form W-4 equivalents, state unemployment insurance, wage and hour law requirements and garnishment withholding.
CD/Recorded
$249
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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
Software Validation and its 11 Key Documents

Software Validation and its 11 Key Documents

  • Speaker: John E Lincoln
  • Product ID: 703097
  • Duration: 90 Min
This webinar focuses on the verification and validation planning and execution of software, after basic developmental testing and de-bug. It includes COTS (commercial off-the-shelf) and the growing field of "cloud"-based software. A suggested FDA model (mandated for submissions) will be evaluated, implemented, with V&V documentation and test case examples. Also attendees will learn the most recent issues the FDA has had in this area, and remediation approaches.
CD/Recorded
$299
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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
$249
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Recorded/CD
Fringe Benefits Blitz for 2019: Taxing and Reporting Fringe Benefits

Fringe Benefits Blitz for 2019: Taxing and Reporting Fringe Benefits

  • Speaker: Vicki M. Lambert
  • Product ID: 705447
  • Duration: 90 Min
This webinar will focus on requirements for taxation and reporting of employee fringe benefits including transportation fringe benefits, section 132 fringe benefits, meals, clothing, housing and education fringe benefits, and third party sick pay. It will also provide best practices to comply with IRS taxation and reporting requirements.
CD/Recorded
$0
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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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