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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
Combination Products - The FDA's New Codifications of the cGMP Requirements Applicable to Combination Products

Combination Products - The FDA's New Codifications of the cGMP Requirements Applicable to Combination Products

  • Speaker: Angela Dunston
  • Product ID: 704623
  • Duration: 120 Min
This training program will analyze the general considerations for cGMP compliance and review the cGMP requirements in 21 CFR 4.4(b). The program will also discuss applications of cGMP requirements for specific types of combination products.
CD/Recorded
$0
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Recorded/CD
The Ever-Changing Role of Arbitration Agreements in California

The Ever-Changing Role of Arbitration Agreements in California

  • Speaker: Jacquiline M Wagner
  • Product ID: 704651
  • Duration: 60 Min
There exists a liberal federal policy favoring arbitration, but a particular provision in the Federal Arbitration Act- or the FAA - known as the savings clause - permits agreements to arbitrate to be invalidated. This training program will discuss how, although there is a general sentiment favoring arbitration on a federal level, in recent years California state courts have aggressively employed the FAA’s savings clause to invalidate arbitration contracts between employers and their employees. This course will help attendees determine whether the arbitration clause in their employment agreement passes muster.
CD/Recorded
$0
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Recorded/CD
Common Audit Triggers

Common Audit Triggers

  • Speaker: Dorothy Steed
  • Product ID: 704618
  • Duration: 60 Min
As payer audits continue to increase in frequency, physician practices are becoming more likely to be cited for significant overpayments and recovery of funds. This training program will highlight why it is vitally important that providers and staff understand how they may be targeted and why they must implement protocols and procedures to diminish the burden of the audit process.
CD/Recorded
$0
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Recorded/CD
Customer Service with a Payroll Twist 2016

Customer Service with a Payroll Twist 2016

  • Speaker: Vicki M. Lambert
  • Product ID: 704613
  • Duration: 90 Min
Excellent customer service assists payroll in its daily operations within the department rather than for its outside customers. This training program will examine how a correctly implemented payroll department customer service policy will ensure that communications remain open and clear. By setting down in writing what the payroll department can and cannot do legally, or will or will not be able to do, right up front goes a long way towards preventing future misunderstandings, miscommunications and the resulting conflicts which cause the department to lose valuable time handling this conflict.
CD/Recorded
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Recorded/CD
WTO Valuation Code - FSFE, DDP, DDU and More

WTO Valuation Code - FSFE, DDP, DDU and More

  • Speaker: Chris Pey
  • Product ID: 704375
  • Duration: 60 Min
This WTO Valuation Code training program will discuss how to properly value products, WTO valuation methodologies, and foreign-based importing and DDP pricing. Best practices for designing compliance procedures which will ensure continued valuation success will be detailed.
CD/Recorded
$199
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Recorded/CD
New Regulation from Department of Labor Definition of Exempt Employees

New Regulation from Department of Labor Definition of Exempt Employees

  • Speaker: Bruce Buchanan
  • Product ID: 704607
  • Duration: 90 Min
This webinar will discuss the impending new regulations from the Department of Labor (DOL) related to white collar salaried exemptions. Instructor will discuss the resultant re-classification of employees, reduction of employees’ hours and increase salary. Participants will also learn how to counter the financial impact of new regulations.
CD/Recorded
$229
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Recorded/CD
ACH Fraud - Detection and Prevention

ACH Fraud - Detection and Prevention

  • Speaker: Rayleen M Pirnie
  • Product ID: 704369
  • Duration: 90 Min
This training program will discuss common forms of ACH fraud, including: social engineering, account takeover (consumer, corporate, and institution internal accounts), money mules and advance fee frauds, and embezzlement. Under each of these sections, the course will also discuss: ACH fraud detection, fraud mitigation, ACH Returns, sound business practices to thwart attempts, and education.
CD/Recorded
$179
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Recorded/CD
Wage and Salary Administration: Setting Ranges, Determining Merit Increases and Bonuses

Wage and Salary Administration: Setting Ranges, Determining Merit Increases and Bonuses

  • Speaker: Marna Hayden
  • Product ID: 704220
  • Duration: 60 Min
This training program will concentrate primarily on establishing a philosophy and program for salary administration that will be in alignment with your organization’s business strategy, be understandable to management and employees and compliant with applicable labor laws.
CD/Recorded
$149
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Recorded/CD
Single-Use Systems and Technologies

Single-Use Systems and Technologies

  • Speaker: Mark Trotter
  • Product ID: 704609
  • Duration: 90 Min
This training program will examine the many facets of disposable bioprocessing systems that incorporate a wide scope of polymeric single-use products. Single-use disposable technologies, from upstream to downstream processes, will be reviewed as related to the use of polymeric devices. Specific attention will be given to the related applications used in the production of biopharmaceuticals and pharmaceuticals.
CD/Recorded
$0
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Recorded/CD
2 Ways to Look at Vulnerability Assessments - Part 1 and Part 2

2 Ways to Look at Vulnerability Assessments - Part 1 and Part 2

  • Speaker: Ned Mitenius
  • Product ID: 704471
  • Duration: 60 Min
This training program is designed for food defense and food safety practitioners who are preparing for implementation of the Intentional Adulteration rule. Those who have existing Food Defense Plans should understand how the vulnerability assessment requirements may go beyond most existing food defense plans and what considerations will be needed to comply with the rule. Operations which have relied on the FDA supplied Food Defense Plan Builder software tool should know the limitations of the existing tool, and how to overcome them, and who is qualified to do so.
CD/Recorded
$0
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Recorded/CD
Affordable Care Act (ACA) Update for 2016-2017 and Beyond

Affordable Care Act (ACA) Update for 2016-2017 and Beyond

  • Speaker: Rob J Thurston
  • Product ID: 704598
  • Duration: 90 Min
This training program will detail the Affordable Care Act law and its rulings. The session will also examine benefits administration and how to ensure compliance and the future of Obama Care.
CD/Recorded
$0
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Recorded/CD
Quality Writing for Technical Communicators

Quality Writing for Technical Communicators

  • Speaker: Phil Vassallo
  • Product ID: 704017
  • Duration: 60 Min
This training program will address the daunting task of conveying complex technical data clearly, concisely, and purposefully to technical and non-expert audiences alike. Writing examples from diverse technical fields makes this webinar highly relevant. The program will build a foundation for learning by identifying the qualities of effective writing and the roadblocks to overcoming them.
CD/Recorded
$199
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Recorded/CD
FDA Vs Health Canada

FDA Vs Health Canada

  • Speaker: Angela Dunston
  • Product ID: 703970
  • Duration: 60 Min
This training program will elucidate the similarities and differences between the FDA and Health Canada promulgations of regulations impact preparation. The course will also offer a review of the background and history behind the FDA and Health Canada.
CD/Recorded
$249
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Recorded/CD
Successful Deviation Investigations

Successful Deviation Investigations

  • Speaker: Danielle DeLucy
  • Product ID: 704596
  • Duration: 60 Min
This training program will help attendees understand the fundamental steps of a deviation investigation with focus on using facts and objective evidence to arrive at root cause and CAPA. This webinar will focus on how to avoid the pitfalls that may occur during FDA inspections and help eliminate 483 observations. Attendees will learn how to identify and avoid potential pitfalls during deviation investigations.
CD/Recorded
$0
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Recorded/CD
Best Practices in Being ‘On Call’ for FDA Submission Audits in the CDISC Programming Environment

Best Practices in Being ‘On Call’ for FDA Submission Audits in the CDISC Programming Environment

  • Speaker: Sunil Gupta
  • Product ID: 704594
  • Duration: 75 Min
This training program will assist anyone directly or indirectly responsible for the creation, content or validation of SDTMs, ADaMs, tables, and data lists used to support research, drug or medical device efficacy and safety in a regulatory submission. It will help attendees in determining how well your company is positioned to defend your FDA submission.
CD/Recorded
$0
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Recorded/CD
Creating FDA-compliant cGMP Training Program

Creating FDA-compliant cGMP Training Program

  • Speaker: Henry Urbach
  • Product ID: 703401
  • Duration: 60 Min
This webinar will explain how to implement an effective and FDA compliant GMP training program. It will discuss regulatory requirements and expectations for a well-trained workforce.
CD/Recorded
$179
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Recorded/CD
Ensuring a Successful Health Care Systems Implementation

Ensuring a Successful Health Care Systems Implementation

  • Speaker: James B Wener
  • Product ID: 704593
  • Duration: 60 Min
This training program will discuss the attributes of a successful system implementation and detail how to convert the successful implementation expectations into measurable metrics. The program will also detail establishing project plans and help identify the resources needed for the project and scheduling tasks.
CD/Recorded
$0
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Recorded/CD
From Chaos to Organized: Whip Those Physician Contracts into Shape

From Chaos to Organized: Whip Those Physician Contracts into Shape

  • Speaker: Nicole Huff
  • Product ID: 703487
  • Duration: 60 Min
This healthcare compliance training will explain how to organize and negotiate physician financial arrangements in order to be ready for internal and external audits. Attendees will learn how to comply with regulatory requirements of Stark Law, the Anti-kickback statute, the False Claims Act (FCA), and IRS tax-exemption code related to physician arrangements.
CD/Recorded
$229
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Recorded/CD
Hazardous Substance Management for Medical Devices and In-Vitro Diagnostics - Comprehensive Regulatory Support for the Supply Chain

Hazardous Substance Management for Medical Devices and In-Vitro Diagnostics - Comprehensive Regulatory Support for the Supply Chain

  • Speaker: Wilhelm Pfleger
  • Product ID: 704228
  • Duration: 60 Min
This training program will offer an interpretation of the latest ruling of Reach SVHC. It will also discuss the RoHS directive – the four substances added to the restriction list in Annex II.
CD/Recorded
$179
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Recorded/CD
Pre-Market Submission Implications of FDA’s Human Factors Guidance and Device Priority List

Pre-Market Submission Implications of FDA’s Human Factors Guidance and Device Priority List

  • Speaker: Robert A North
  • Product ID: 704551
  • Duration: 90 Min
This training program will explore why human factors has become a vital part of the FDA’s medical device pre-market approval/clearance process. The FDA Center for Devices and Radiological Health (CDRH) recently issued two guidance documents on human factors that are key elements in determining pre-market submission strategies for manufacturers. In this webinar, attendees will learn how to provide clear and complete human factors submissions meeting the intent of these guidance.
CD/Recorded
$229
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