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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
Pharmacokinetics/Biopharmaceutics for Chemists/Analysts

Pharmacokinetics/Biopharmaceutics for Chemists/Analysts

  • Speaker: Saeed Qureshi
  • Product ID: 705271
  • Duration: 120 Min
This training program will focus on defining and explaining numerous concepts and terminologies in a simple language as related to the safety, efficacy and quality assessment of pharmaceutical products for human use. It will also describe the necessity of understanding the basic physiological concepts pertinent to drug actions, product developments and evaluations.
CD/Recorded
$0
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Recorded/CD
Sample Quality Control for Molecular Diagnostics

Sample Quality Control for Molecular Diagnostics

  • Speaker: Todd Graham
  • Product ID: 705222
  • Duration: 60 Min
In this webinar attendees will learn the key issues and sample requirements (collection methods, sample inhibition and sample volume) for molecular diagnostics and the tools (PCR, DNA fluorescent assays & NGS assays) you need to deal with your laboratory challenges in clinical laboratory.
CD/Recorded
$299
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Recorded/CD
The Provider Self Disclosure Protocol (SDP) and the OIG- Compliance: Self - Reporting to OIG - When should this happen and how to do it?

The Provider Self Disclosure Protocol (SDP) and the OIG- Compliance: Self - Reporting to OIG - When should this happen and how to do it?

  • Speaker: Laura S Hargraves
  • Product ID: 703203
  • Duration: 60 Min
This training on OIG Self-Disclosure Protocol will help the attendees on the revised self-disclosure protocol (SDP), the process and procedures for self-reporting and the risks of not self-reporting. It will also review the need for the organization to be aware of excluded entities.
CD/Recorded
$249
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Recorded/CD
Achieving Success and Compliance in the Supply Chain

Achieving Success and Compliance in the Supply Chain

  • Speaker: Danielle DeLucy
  • Product ID: 705907
  • Duration: 60 Min
This webinar will help attendees to understand the quality issues and methodologies that are relevant in current supply chain management to improve your customer satisfaction.
CD/Recorded
$0
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Recorded/CD
ASTM 2500: Lessons Learned Through a Decade of Implementation

ASTM 2500: Lessons Learned Through a Decade of Implementation

  • Speaker: Kelly Thomas
  • Product ID: 705911
  • Duration: 90 Min
This validation training program will discuss regulatory requirements from the FDA, EU and ICH perspective, review all the detailed guidance on the concepts found in ASTM E2500 to help industry professionals understand how to implement a validation program based on the ASTM 2500 Approach.
CD/Recorded
$0
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Recorded/CD
Data Governance for Computer Systems Regulated by FDA

Data Governance for Computer Systems Regulated by FDA

  • Speaker: Carolyn Troiano
  • Product ID: 704745
  • Duration: 60 Min
In this webinar attendees will learn about FDA’s regulatory expectations for classifying, assessing the risk, testing, and validating a computer system used in FDA-regulated work. Also attendees will learn in detail about the System Development Life Cycle (SDLC) methodology used to approach Computer System Validation (CSV), including all of the phases, sequencing of events, deliverables, and documentation requirements.
CD/Recorded
$199
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Recorded/CD
Prevent Accidents: Root Causes, Investigation and Avoidance Plans

Prevent Accidents: Root Causes, Investigation and Avoidance Plans

  • Speaker: Keith Warwick
  • Product ID: 704875
  • Duration: 90 Min
This webinar training program will discuss how to develop an accident investigation plan, manage cost, and develop realistic schedule. Participants will learn about the interview process, protecting site of incident, determining root cause, and avoidance plan.
CD/Recorded
$199
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Recorded/CD
Cell Based Assays: Development and Validation

Cell Based Assays: Development and Validation

  • Speaker: Michael Simonian
  • Product ID: 704528
  • Duration: 60 Min
This training program will focus on how cell cultures are used for in vitro assays. It will include examples of cell based assay systems and list the advantages of cell based assays. The webinar will help attendees understand the uses of in vitro testing with eukaryotic cell based systems, the parameters to be considered in the development and optimization of a cell based assay and the validation of a cell based assay.
CD/Recorded
$0
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Recorded/CD
Form W-2 for 2019: All You Need to Know

Form W-2 for 2019: All You Need to Know

  • Speaker: Vicki M. Lambert
  • Product ID: 703816
  • Duration: 90 Min
This training program will discuss various aspects of the IRS Form W-2 for 2019. The webinar will cover requirements for completing and filing the form including a box by box explanation. Best practices for completing and reconciling the form, and handling duplicate requests from employees will also be covered. The webinar training will further look at when to use the correction Form W-2c and the latest requirements for the Affordable Health Care Act as it relates to reporting requirements on the form.
CD/Recorded
$229
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Recorded/CD
Documentary Letter of Credit Terms and Conditions

Documentary Letter of Credit Terms and Conditions

  • Speaker: John Dunlop
  • Product ID: 702216
  • Duration: 60 Min
The objective of this 60 minute webinar is to help exporters and importers understand Letter of Credit terms and conditions that go into structuring a transaction for successful payment and receipt of goods. Attendees will learn how to use Letters of Credit to assure payment for exports, how to apply for a Letter of Credit and what terms and conditions should be used for successful transactions.
CD/Recorded
$179
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Recorded/CD
How to Think Like an Accountable Care Organization - Integrating Case Management Across the Continuum

How to Think Like an Accountable Care Organization - Integrating Case Management Across the Continuum

  • Speaker: Toni Cesta
  • Product ID: 705201
  • Duration: 60 Min
This program provides the attendee with concrete and implementable strategies for integrating and embedding case management across the continuum of care.
CD/Recorded
$199
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Recorded/CD
How to prepare for a CBP Audit

How to prepare for a CBP Audit

  • Speaker: Raymond Sullivan
  • Product ID: 705352
  • Duration: 60 Min
This CBP audit preparation training program will help attendees move toward a systematic approach for both general compliance and when notified about a CBP audit. It will help identify the likelihood of being subject to CBP audits, and help spot potential vulnerabilities and test your compliance (potential vulnerability, self review and general audit issues).
CD/Recorded
$179
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Recorded/CD
Assay Validation for Clinical Diagnostics

Assay Validation for Clinical Diagnostics

  • Speaker: Todd Graham
  • Product ID: 702872
  • Duration: 60 Min
This training on assay validation will teach you how to validate an assay for clinical diagnostics and transition the assay into the clinical laboratory for diagnostic use.
CD/Recorded
$249
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Recorded/CD
Processes & Effects of Immunogenicity to Biologics & the Screening Methodologies - 3 hour Virtual Training

Processes & Effects of Immunogenicity to Biologics & the Screening Methodologies - 3 hour Virtual Training

  • Speaker: Gwen Wise Blackman
  • Product ID: 705019
  • Duration: 180 Min
This 3 hour virtual training will provide an overview of the concepts and types of immune responses elicited by biologics. The factors contributing to immunogenicity and impact on efficacy and safety will be identified. Validated screening and confirmatory methods that measure an immune response to a biologic during the various stages of development, clinical studies and post-approval surveillance will be discussed.
CD/Recorded
$349
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Recorded/CD
Mastering Medicare and Medicaid Marketing Regulations: Do's and Don'ts

Mastering Medicare and Medicaid Marketing Regulations: Do's and Don'ts

  • Speaker: William Mack Copeland
  • Product ID: 705230
  • Duration: 60 Min
This webinar will review not only the Anti-Kickback Statute and its safe harbors, but will provide an in-depth overview of OIG guidance and advisory opinions dealing with marketing activities, as well as a review of case law regarding marketing behavior.
CD/Recorded
$229
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Recorded/CD
Cal/OSHA Enforcement and Defenses - Recent Changes in the Law

Cal/OSHA Enforcement and Defenses - Recent Changes in the Law

  • Speaker: James T. Dufour
  • Product ID: 701977
  • Duration: 90 Min
This webinar on Cal/OSHA Enforcement and Defenses will cover the recent changes in the law, specifically the four most significant developments in Cal/OSHA enforcement and defense that will have an impact in 2015.
CD/Recorded
$199
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Recorded/CD
Drafting a Software Verification and Validation Report Package and Protocol - The 11 Must-have Documents

Drafting a Software Verification and Validation Report Package and Protocol - The 11 Must-have Documents

  • Speaker: John E Lincoln
  • Product ID: 704848
  • Duration: 90 Min
A tougher U.S. FDA expects a company to maintain certain documents in equipment, process and product software V&V. These documentation requirements can assist in a 21 CFR Part 11 CGMP records / signature V&V as well. This training program will provide valuable assistance to all regulated companies in evaluating their existing or anticipated software V&V activities and documentation requirements, especially in light of the changes in the FDA's stance vis a vis industry compliance, past problems, and the growing cloud environment. It will help attendees understand and recognize the most common software V&V failings and their fixes. The webinar will allow attendees to develop and use a repeatable software V&V template for all software validation projects.
CD/Recorded
$199
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Recorded/CD
CMS Hospital Improvement Act Proposed Changes: Nursing, Medical Records, Infection Control, Antibiotic Stewardship Program, Restraints, QAPI

CMS Hospital Improvement Act Proposed Changes: Nursing, Medical Records, Infection Control, Antibiotic Stewardship Program, Restraints, QAPI

  • Speaker: Sue Dill Calloway
  • Product ID: 705197
  • Duration: 120 Min
This program is going to cover the proposed changes that CMS wants to make for all hospitals including critical access hospitals. These changes will affect many different departments of the hospital including nursing, QAPI, medical records, lab, restraint standards, discrimination, patient rights, and more.
CD/Recorded
$279
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Recorded/CD
The Board of Directors Role in Cybersecurity

The Board of Directors Role in Cybersecurity

  • Speaker: Rayleen M Pirnie
  • Product ID: 705117
  • Duration: 60 Min
This webinar will break down the Board’s role in effective cybersecurity oversight, the 12 questions a board member should be knowing to answer, key principles of oversight, tips and resources for board.
CD/Recorded
$179
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Recorded/CD
OSHA Enforcement for Employers Using Temporary Workers

OSHA Enforcement for Employers Using Temporary Workers

  • Speaker: William Principe
  • Product ID: 703031
  • Duration: 90 Min
This workplace safety compliance training will explain OSHA’s initiative to protect temporary workers. It will also provide you the tools to ensure compliance with OSHA requirements when employing temporary workers.
CD/Recorded
$229
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