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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
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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Recorded/CD
Preparing for a UDI Implementation

Preparing for a UDI Implementation

  • Speaker: Lena Cordie Bancroft
  • Product ID: 704579
  • Duration: 90 Min
This training program will help attendees understand the requirements of the FDA UDI regulation and the labeling requirements of the UDI regulation. The program will also focus on data elements that make up a UDI compliant barcode and GUDID data attributes and submission process.
CD/Recorded
$0
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Recorded/CD
A Critical Review of the New Medical Cannabis Regulatory Regime in California

A Critical Review of the New Medical Cannabis Regulatory Regime in California

  • Speaker: Erik Janus
  • Product ID: 704578
  • Duration: 60 Min
This training program will examine key questions on how California’s future medical cannabis market will look like when it comes to regulation. In the next two years, multiple state agencies will be involved in filling in the blank spaces left by MMRSA. For example: What will licensure fees look like? How will “edibles” be regulated in California? In the background, a new President will be elected soon and this could influence the future of all state-based medical cannabis markets. Insight and opinion on all these issues will be provided by a regulatory expert with years of expertise in influencing state and federal decision-making and policy.
CD/Recorded
$0
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Recorded/CD
How to Plan for the Proposed Changes to the Fair Labor Standards Act (FLSA) - Part 1

How to Plan for the Proposed Changes to the Fair Labor Standards Act (FLSA) - Part 1

  • Speaker: Bob McKenzie
  • Product ID: 704581
  • Duration: 60 Min
This training program will offer best practices for staying in compliance with the Fair Labor Standards Act when the proposed regulations are released while exploring the critical nature of the right communications. It will be followed-up by a 60 minutes complimentary Q&A Session(Series2)on Monday, May 9th 2016.
CD/Recorded
$149
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Recorded/CD
Exporting: A Business of Details

Exporting: A Business of Details

  • Speaker: Iliyana Hristev
  • Product ID: 704569
  • Duration: 90 Min
Beginning with the initial interest and concluding with payment, this training program will provide a handy flow-chart for consideration and guidelines of exactly how to execute a successful transaction, from conception through connection and up until collection. It also indicates options available to the exporter based on size and value of shipment, country of destination and type of buyer.
CD/Recorded
$0
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Recorded/CD
How to Create Effective Employee Newsletters

How to Create Effective Employee Newsletters

  • Speaker: Randall A Olson
  • Product ID: 704564
  • Duration: 60 Min
This training program will help you determine if an employee newsletter is right for your company. Attendees will further learn best practices for newsletter content, design and distribution, and how to create and oversee the development and production of employee newsletters.
CD/Recorded
$25
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Recorded/CD
Implementation of Rapid Microbial Methods for Air and Water Monitoring in Pharmaceutical Industry

Implementation of Rapid Microbial Methods for Air and Water Monitoring in Pharmaceutical Industry

  • Speaker: Igor Gorsky
  • Product ID: 704560
  • Duration: 2 hrs
This training program will dispel mistaken paradigms regarding the risk based approach to introduction of rapid microbial detection systems for water systems. Attendees will understand how to validate and transfer LIF method and how to validate LIF instrument against currently used methods.
CD/Recorded
$0
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Recorded/CD
Food Defense - Is your organization safe?

Food Defense - Is your organization safe?

  • Speaker: Jason Teliszczak
  • Product ID: 703271
  • Duration: 60 Min
This food defense webinar will detail what an organization needs to have in place in order to safely manufacture, package, and or handle food products. It will cover a broad range of production types, facilities, and the transportation of goods. This webinar will highlight key areas of the organization that need to be controlled to ensure that intentional contaminants do not enter the product by potential threats.
CD/Recorded
$199
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Recorded/CD
HIPAA Privacy Rule, Patient Access, and Communications - New Guidance, New Issues, and New Threats to Compliance

HIPAA Privacy Rule, Patient Access, and Communications - New Guidance, New Issues, and New Threats to Compliance

  • Speaker: Jim Sheldon-Dean
  • Product ID: 704472
  • Duration: 4 hrs
This training program will review why all HIPAA-covered providers need to review their HIPAA compliance, policies, and procedures to see if they are prepared to be in full compliance and meet the requirements of the changes in the rules. Compliance is required and violations for willful neglect of the rules begin at $10,000.
CD/Recorded
$0
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Recorded/CD
Extractables and Leachables Testing for Polymeric Materials Used in Pharmaceutical Industry: An Introduction and Strategies in Current Practice

Extractables and Leachables Testing for Polymeric Materials Used in Pharmaceutical Industry: An Introduction and Strategies in Current Practice

  • Speaker: Armin Hauk
  • Product ID: 704340
  • Duration: 60 Min
This training program will offer participants an understanding of the concept of E&L (Extractables and Leachables) studies and about developing an E&L study in a reasonable and pragmatic way - based on regulatory requirements, guidelines and recommendations.
CD/Recorded
$169
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Recorded/CD
FDA Regulations on Usage of New Pharmaceutical Agents to Fight Infection

FDA Regulations on Usage of New Pharmaceutical Agents to Fight Infection

  • Speaker: Thomas Webster
  • Product ID: 704559
  • Duration: 2 hrs
This training program will discuss fundamentals of infection and the use of materials/drugs to fight infection, FDA regulatory approvals for drugs and materials used to fight infection, and future thoughts on approaches to fight infection.
CD/Recorded
$0
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Recorded/CD
US, EU, Japan GMP Requirements: Practical ICH Area Differences, Healthcare Authority Inspection Focus

US, EU, Japan GMP Requirements: Practical ICH Area Differences, Healthcare Authority Inspection Focus

  • Speaker: Robert J Russell
  • Product ID: 704587
  • Duration: 90 Min
This 90-minute webinar will help you gain a comprehensive understanding of ICH GMPs and the nuances and differences between requirements in the US, EU and Japan. It will prepare you for regulatory inspections in these countries.
CD/Recorded
$229
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Recorded/CD
International Background Checks: Global Due Diligence and Legal Compliance

International Background Checks: Global Due Diligence and Legal Compliance

  • Speaker: Lester S Rosen
  • Product ID: 704554
  • Duration: 75 Min
Employers have long recognized that conducting due diligence on new hires is a mission critical task. This training program will focus on why firms cannot afford to ignore employee-related problems such as workplace violence, theft, false resumes, embezzlement, harassment or trumped-up injury claims. Employers can be the subject of lawsuits for negligent hiring if they hire someone that they should have known, through the exercise of due diligence, was dangerous, unfit or unqualified.
CD/Recorded
$0
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Recorded/CD
Cyber Incident Response: The Payments Perspective - Threat Intelligence and Best Practices to Manage Threats

Cyber Incident Response: The Payments Perspective - Threat Intelligence and Best Practices to Manage Threats

  • Speaker: Rayleen M Pirnie
  • Product ID: 704443
  • Duration: 90 Min
This training program will discuss how cyber-attacks affect payment processing. It will highlight to attendees how best to record appropriate sound business practices for managing operational risk due to a cyber-attack. Attendees will also learn to identify critical operational communications, from internal staff to customers and institutions to vendor support.
CD/Recorded
$149
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Recorded/CD
Trade Compliance ROI: What Do I Get For My Compliance Dollar?

Trade Compliance ROI: What Do I Get For My Compliance Dollar?

  • Speaker: Grant Smith
  • Product ID: 704575
  • Duration: 60 Min
This training program will cover return on investment (ROI) for trade compliance. It will cover the investment that must be made to realize a return. The program will help import and export professionals learn what the future will look like, while global trade professionals will be able to identify applicable risks and costs, and brokers and forwarders will benefit from new customer offerings.
CD/Recorded
$0
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