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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
HIPAA Planning for 2020 and Beyond - Protecting Patient Information Privacy and Security

HIPAA Planning for 2020 and Beyond - Protecting Patient Information Privacy and Security

  • Speaker: Jim Sheldon-Dean
  • Product ID: 704975
  • Duration: 90 Min
This HIPAA compliance webinar will discuss the issues in patient information privacy and security that healthcare organizations will face in 2020 and how to ensure compliance with HIPAA that will withstand incidents, audits, and investigations by HHS.
CD/Recorded
$179
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Recorded/CD
CDISC Mapping 5: ADAM Models - ADSL, BDS and ADAE

CDISC Mapping 5: ADAM Models - ADSL, BDS and ADAE

  • Speaker: Sunil Gupta
  • Product ID: 704316
  • Duration: 90 Min
This training session is intended for anyone directly or indirectly responsible for the creation, content or validation of CDISC data sets, tables, and data lists used to support research, drug or medical device efficacy and safety in a regulatory submission. The program will provide effective and practical solutions to address real-world issues.
CD/Recorded
$159
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Recorded/CD
Risk Management of Source Water used in the Food Industry

Risk Management of Source Water used in the Food Industry

  • Speaker: Michael Brodsky
  • Product ID: 703211
  • Duration: 60 Min
This training on source water protection will address the issue of source water protection and the potential impact on the food industry. Attendees will learn the best practices for the protection of source water and risk management from a microbiological perspective.
CD/Recorded
$0
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Recorded/CD
Child Support and Garnishments - All You Need To Know

Child Support and Garnishments - All You Need To Know

  • Speaker: David Sanders
  • Product ID: 705089
  • Duration: 90 Min
This webinar will enhance your knowledge by helping you understand the basics of garnishments, liens and levies, how to identify and define their various types, and how to calculate them. This webinar training will help you better understand the various techniques used by your company.
CD/Recorded
$169
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Recorded/CD
OSHA Record Keeping Compliance

OSHA Record Keeping Compliance

  • Speaker: Kenneth S. Weinberg
  • Product ID: 702775
  • Duration: 60 Min
This OSHA Recordkeeping training will cover critical aspects of OSHA recordkeeping and its requirements, to be compliant with OSHA regulations.
CD/Recorded
$199
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Recorded/CD
CDISC Mapping 4: SDTMs and ADAMs Examples (80%/20% Mapping Rule)

CDISC Mapping 4: SDTMs and ADAMs Examples (80%/20% Mapping Rule)

  • Speaker: Sunil Gupta
  • Product ID: 704313
  • Duration: 90 Min
This training program is intended for anyone directly or indirectly responsible for the creation, content or validation of CDISC data sets, tables, and data lists used to support research, drug or medical device efficacy and safety in a regulatory submission. Through case study analysis, the course will examine best practices to provide thoughts and ideas to develop or improve the CDISC mapping system.
CD/Recorded
$299
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Recorded/CD
Sarbanes-Oxley Act Section 404: How to Establish an Effective Internal Controls System

Sarbanes-Oxley Act Section 404: How to Establish an Effective Internal Controls System

  • Speaker: David Sanders
  • Product ID: 704395
  • Duration: 90 Min
This webinar will enhance your knowledge of SOX Section 404 (Sarbanes-Oxley Act Section 404) by helping you understand the elements of an internal controls system. Internal controls are a key part of any organization's continued growth, performance and success. With fraud at an all-time high, a well-designed internal control structure will enhance operations by improving your department's overall security and effectiveness. SOX Section 404 mandates that all publicly-traded companies must establish internal controls and procedures for financial reporting and must document, test and maintain those controls and procedures to ensure their effectiveness.
CD/Recorded
$249
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Recorded/CD
Understanding Aseptic Technique and Cleanroom Behavior

Understanding Aseptic Technique and Cleanroom Behavior

  • Speaker: Danielle DeLucy
  • Product ID: 704429
  • Duration: 60 Min
This training program will discuss how, in sterile compounding, aseptic technique is contributing to the prevention of microbiological contamination. It provides sterility, safety, and efficacy to the sterile product, especially various injections for patients. In this course, cleaning, gowning and proper methods of contamination control will be reviewed along with why clean rooms are designed the way they are.
CD/Recorded
$299
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Recorded/CD
HIPAA Gap Analysis, Risk Assessment and Risk Analysis - Finding and Managing Risks to Protected Health Information

HIPAA Gap Analysis, Risk Assessment and Risk Analysis - Finding and Managing Risks to Protected Health Information

  • Speaker: Jim Sheldon-Dean
  • Product ID: 703180
  • Duration: 90 Min
This training on HIPAA compliance will teach the attendees how to examine their security policies, practices, and risk issues to find and fill any gaps in the documentation that is required by the HIPAA rules to show compliance, survive audits, and avoid enforcement action.
CD/Recorded
$199
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Recorded/CD
Medical Records: Compliance with CMS Hospital CoPs and Proposed Changes

Medical Records: Compliance with CMS Hospital CoPs and Proposed Changes

  • Speaker: Sue Dill Calloway
  • Product ID: 705244
  • Duration: 120 Min
This training program will cover in detail the CMS regulations and interpretive guidelines for medical records. It will also discuss important proposed changes to the CMS discharge planning standards including changes to the federal law on alcohol and drug records.
CD/Recorded
$349
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Recorded/CD
FATCA - Implications, Changes and How to Implement in a Foreign Financial Institution

FATCA - Implications, Changes and How to Implement in a Foreign Financial Institution

  • Speaker: Jason Simpson
  • Product ID: 702989
  • Duration: 60 Min
This training on Foreign Account Tax Compliance Act (FATCA ) will highlight the evolution of the Act and its current regulations. It will also provide attendees practical and effective methods for solid FATCA implementation along with tools for identifying FATCA specific complexities in order to avoid enforcement actions.
CD/Recorded
$249
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Recorded/CD
Record Retention and Destruction Compliance

Record Retention and Destruction Compliance

  • Speaker: David Sanders
  • Product ID: 704445
  • Duration: 90 Min
This training program will offer attendees an understanding of record schedule defensibility and best practices to take steps toward improvements. The IRS states entities need to be fully informed of the code relating to Record Retention and Destruction to determine what records are necessary to stay in compliance or face fines. According to IRS and state statistics of the entities audited over the past three years, 82% could not supply adequate records to pass an audit - resulting in substantial fines for non-compliance.
CD/Recorded
$249
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Recorded/CD
Vendor Qualification - How to Design and Implement an Efficient and Compliant Vendor Program

Vendor Qualification - How to Design and Implement an Efficient and Compliant Vendor Program

  • Speaker: Todd Graham
  • Product ID: 703066
  • Duration: 60 Min
This webinar will tell you what you need to know to design a compliant vendor program, implement it throughout the organization, manage the necessary documentation and effectively communicate with vendors your requirements, needs and issues.
CD/Recorded
$299
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Recorded/CD
Nursing: CMS CoP Standards for Hospitals and Proposed Changes: 2019 Update

Nursing: CMS CoP Standards for Hospitals and Proposed Changes: 2019 Update

  • Speaker: Sue Dill Calloway
  • Product ID: 705239
  • Duration: 120 Min
This training program will cover requirements in the CMS hospital CoP manual on nursing section. It will discuss proposed changes in the Hospital Improvement Act including plans of care, staffing, policy changes, documentation, supervision, nursing leadership, verbal orders, antibiotic stewardship program and much more.
CD/Recorded
$249
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Recorded/CD
CDISC Mapping 3: Compare and Contrast SDTM and ADaM Steps

CDISC Mapping 3: Compare and Contrast SDTM and ADaM Steps

  • Speaker: Sunil Gupta
  • Product ID: 704302
  • Duration: 90 Min
This training program will assist anyone directly or indirectly responsible for the creation, content or validation of CDISC data sets, tables, and data lists used to support research, drug or medical device efficacy and safety in a regulatory submission. Professionals in the pharmaceutical, biotechnology and medical device industries who want to be Good Clinical Practices (GCP) compliant in relation to regulatory submission environment will benefit from this training. Effective and practical solutions to address real-world issues will be detailed.
CD/Recorded
$299
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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
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
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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