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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
ICH Addendum and its Implication on Clinical Development

ICH Addendum and its Implication on Clinical Development

  • Speaker: Beat Widler
  • Product ID: 704636
  • Duration: 60 Min
This training program will discuss investigator oversight and responsibilities, records management including source data, trial data handling and procedures, quality and risk management, vendor oversight and subcontracting, risk-based monitoring and last but not least root cause analyses in case of non-compliances.
CD/Recorded
$0
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Recorded/CD
Conducting Sound Workplace Investigations for California Employers

Conducting Sound Workplace Investigations for California Employers

  • Speaker: Jacquiline M Wagner
  • Product ID: 704632
  • Duration: 60 Min
This training program will discuss the California Fair Employment and Housing Act under which an employer has an obligation to take all reasonable steps necessary to prevent discrimination and harassment from occurring in the workplace. The affirmative and mandatory duty requires the employer to conduct a prompt investigation in the event of a discrimination claim.
CD/Recorded
$0
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Recorded/CD
The Top Ten Trends for Background Checks in 2016 - What Every Employer Needs to Know

The Top Ten Trends for Background Checks in 2016 - What Every Employer Needs to Know

  • Speaker: Lester S Rosen
  • Product ID: 704628
  • Duration: 75 Min
In this training program, attendees will understand why background checks and due diligence have become mission critical for employers. This program will review the top ten trends and best practices for 2016 when it comes to background checks and safe hiring. Learn steps employers can take immediately to help ensure legal compliance and how to deal with Ban the Box rules concerning criminal records.
CD/Recorded
$0
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Recorded/CD
California Transparency in Supply Chains Act of 2010 - Comply with SB 657

California Transparency in Supply Chains Act of 2010 - Comply with SB 657

  • Speaker: Grant Smith
  • Product ID: 704381
  • Duration: 60 Min
In this training program, participants will learn how to answer inquiries from customers and suppliers. Legal departments who are concerned about confidential, proprietary and/or trade secret information will learn how they can refer to the Act or when they should seek outside counsel. California consumers are concerned about human trafficking and forced labor. It can hurt the business’s bottom line if they are not satisfied that a company is doing a satisfactory job of rooting out bad suppliers.
CD/Recorded
$0
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Recorded/CD
Biomarkers in Drug Development

Biomarkers in Drug Development

  • Speaker: Juan Leal
  • Product ID: 704068
  • Duration: 60 Min
This webinar will help attendees obtain the fundamentals of the science, clinical operations and clinical regulatory aspects of biomarker(s) identification, validation and application in clinical trials.
CD/Recorded
$229
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Recorded/CD
Provider Based Status - What's in Your Compliance Toolkit?

Provider Based Status - What's in Your Compliance Toolkit?

  • Speaker: Nicole Huff
  • Product ID: 703452
  • Duration: 60 Min
This webinar will explain how to set up and sustain a provider based clinic or location in compliance with the CMS requirements to avoid potential fines and penalties. It will provide an overview of applicable standards for on-campus and off-campus locations.
CD/Recorded
$229
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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
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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
$199
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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
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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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