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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
Predicting Plasma Drug Levels and Relevant Concepts of Convolution/Deconvolution and In Vitro-In Vivo Correlations (IVIVC)

Predicting Plasma Drug Levels and Relevant Concepts of Convolution/Deconvolution and In Vitro-In Vivo Correlations (IVIVC)

  • Speaker: Saeed Qureshi
  • Product ID: 705280
  • Duration: 120 Min
This training program will discuss in detail the method for predicting plasma drug levels from in vitro dissolution results. It will also provide details of the underlying scientific principles involved such as convolution, deconvolution and IVIVC with simple practical examples.
CD/Recorded
$0
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Recorded/CD
Is it FMLA or the "Friday-Monday Leave Act"? How to Identify and Investigate Employees Who Are Gaming the System

Is it FMLA or the "Friday-Monday Leave Act"? How to Identify and Investigate Employees Who Are Gaming the System

  • Speaker: Meloney Sallie Dosunmu
  • Product ID: 705043
  • Duration: 60 Min
This training program will describe the patterns that may indicate FMLA abuse, and how to respond to them. It will also define five key steps to an effective FMLA investigation and offer best practices companies can use to eliminate or reduce the likelihood of FMLA abuse.
CD/Recorded
$169
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Recorded/CD
Acceptance Activities in FDA QSR

Acceptance Activities in FDA QSR

  • Speaker: Daniel O Leary
  • Product ID: 702267
  • Duration: 90 Min
This webinar will explain FDA QSR requirements for acceptance activities related to medical device manufacturing. It will analyze recent Warning Letters and provide tips to ensure that your acceptance activities fully complies with the regulatory requirements.
CD/Recorded
$229
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Recorded/CD
Annual Current Good Clinical Practices (cGCP) Training

Annual Current Good Clinical Practices (cGCP) Training

  • Speaker: Shana Dressel
  • Product ID: 705408
  • Duration: 60 Min
This webinar will cover background information and history of clinical research and drug development, followed by review of the federal regulations, International Council for Harmonisation (ICH), and Good Clinical Practices (GCP) that apply to clinical research.
CD/Recorded
$249
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Recorded/CD
Exclusive Cyber Security Incident Management Program 2017

Exclusive Cyber Security Incident Management Program 2017

  • Speaker: William Akel
  • Product ID: 705380
  • Duration: 60 Min
Gain a better understanding of cyber security incident management that is proactive versus reactive, learn methods to minimize business disruption and damages, and the impact and urgency on customers and the business for risk and costs.
CD/Recorded
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Recorded/CD
Application of CMS Quality Indicator Process in Healthcare Food Service

Application of CMS Quality Indicator Process in Healthcare Food Service

  • Speaker: Larry David Bowe
  • Product ID: 705395
  • Duration: 90 Min
This webinar will offer a fundamental understanding of CMS Quality Indicator Process in healthcare specific to food service. Participants will be offered advice, materials and tools to implementation and quality measure that promote the delivery of quality services, and to prevent negative outcomes in dining, nutrition services.
CD/Recorded
$0
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Recorded/CD
Essential Guide to Medical Record Documentation for the SNF

Essential Guide to Medical Record Documentation for the SNF

  • Speaker: Elisa Bovee
  • Product ID: 705284
  • Duration: 60 Min
The training program will allow directors and clinicians to establish best practices for thriving medical documentation patterns and practices. It will provide an overview of how the interdisciplinary team can successfully establish protocols and strategies for clear, concise and supportive documentation.
CD/Recorded
$0
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Recorded/CD
The Importance of HR Documentation and Notice Requirements

The Importance of HR Documentation and Notice Requirements

  • Speaker: Stuart Silverman
  • Product ID: 705159
  • Duration: 60 Min
Documenting events is a crucial task, and in some cases not documenting them can lead to grim consequences. For example, did you know that not keeping track of employee’s hours is fatal to overtime cases? Sometimes you might be documenting items, but focusing on the wrong items. In this training program, the webinar instructor will discuss what needs to be documented and what should be documented that strengthens employers’ defence in the event lawsuits are filed.
CD/Recorded
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Recorded/CD
Employee Discharge and Documentation: Using Documentation to Control the Employment Relationship

Employee Discharge and Documentation: Using Documentation to Control the Employment Relationship

  • Speaker: Matthew W Burr
  • Product ID: 705378
  • Duration: 60 Min
This webinar focuses on effective ways to manage the employment relationship. The session will address discharge and processes, documentation, training recommendations, performance evaluations, process consistency, and other common concerns and mistakes.
CD/Recorded
$0
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Recorded/CD
HR Record Retention & Destruction: If it’s not documented, it never happened

HR Record Retention & Destruction: If it’s not documented, it never happened

  • Speaker: Kristin Robinson
  • Product ID: 705398
  • Duration: 60 Min
This HR documentation webinar will provide an overview of federal recordkeeping and retention laws for employment-related records and what you need to do to ensure compliance. We'll discuss documentation policies, accessibility controls, considerations for electronic records and more in this webinar training.
CD/Recorded
$179
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Recorded/CD
How to Establish and Maintain a Design History File for a Medical Device

How to Establish and Maintain a Design History File for a Medical Device

  • Speaker: Mary Nunnally
  • Product ID: 705287
  • Duration: 60 Min
This device compliance training will offer a basic understanding of the records required to fulfill requirements of both US FDA 21 CFR 820 and ISO 13485:2016 for establishment and maintenance of a Design History File (DHF). It will also help attendees understand what document control means for DHF records.
CD/Recorded
$229
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Recorded/CD
Do you use Ion Chromatography?

Do you use Ion Chromatography?

  • Speaker: John Fetzer
  • Product ID: 705290
  • Duration: 90 Min
This webinar will cover in detail the various ion separation methods, their strengths, weaknesses, and applicability to various analytical problems and sample types. It will also include a discussion on ion detection and especially the area of ion suppression for electrical-conductance detection.
CD/Recorded
$0
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Recorded/CD
Pharmaceutical Water Systems

Pharmaceutical Water Systems

  • Speaker: Carl Patterson
  • Product ID: 705311
  • Duration: 60 Min
This webinar provides an overview on the different types of water systems used in the pharmaceutical industry. Attendees will be provided a comprehensive overview of the different types of water systems, their validation, and handling of excursions.
CD/Recorded
$0
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Recorded/CD
Importing Marketing Channel Audits

Importing Marketing Channel Audits

  • Speaker: Rossano V Gerald
  • Product ID: 705371
  • Duration: 60 Min
This webinar training is designed to address the import record-keeping and audit compliance procedures that will emphasize the importer obligation to maintain and assess internal and external records that are related to their international trade transactions. It focuses on the role of the import compliance manager, and record-keeping compliance procedures, and the approved standard import and customs forms that will fulfill specific legal requirements in the global logistics environment.
CD/Recorded
$0
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Recorded/CD
21 CFR 111 GMP Dietary Supplement Laboratory

21 CFR 111 GMP Dietary Supplement Laboratory

  • Speaker: Gwen Wise Blackman
  • Product ID: 705288
  • Duration: 60 Min
This training program will provide an overview of 21 CFR 111 regulatory requirements which governs how dietary supplements are manufactured and tested. It will futher review the test procedures and documentation requirements to ensure regulatory compliance.
CD/Recorded
$229
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Recorded/CD
FDA Import Alert - 2017

FDA Import Alert - 2017

  • Speaker: Casper Uldriks
  • Product ID: 705323
  • Duration: 60 Min
This webinar will cover US FDA and Customs legal import requirements including discussion on FDA product codes, Custom's Harmonized Tariff Schedule (HTS) and Affirmation of Compliance (AOC). It will also provide information on FDA's software screening program, PREDICT, and U.S. Custom's ACE program.
CD/Recorded
$249
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Recorded/CD
Compliant Managed Medicare Medical Review Claim Submissions

Compliant Managed Medicare Medical Review Claim Submissions

  • Speaker: Elisa Bovee
  • Product ID: 705296
  • Duration: 60 Min
This training program will review the changes to the Medicare advantage program enacted in the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA). It will provide a step by step approach to ensure accurate appropriate reimbursement.
CD/Recorded
$0
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Recorded/CD
H-1B/LCA Compliance Training - Determining the Appropriate O*Net Area Prevailing Wage Level

H-1B/LCA Compliance Training - Determining the Appropriate O*Net Area Prevailing Wage Level

  • Speaker: Mary E Pivec
  • Product ID: 705357
  • Duration: 90 Min
This training program will focus on current DOL/ETA prevailing wage policy guidance (H-1B and PERM), DOL/WHD wage “leveling” authority in enforcement investigations, the “safe harbor” rule, and more.
CD/Recorded
$0
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Recorded/CD
Criminal Background Checks in the Hiring Process - What Every Employer Needs to Know - EEOC and FCRA

Criminal Background Checks in the Hiring Process - What Every Employer Needs to Know - EEOC and FCRA

  • Speaker: Janette Levey Frisch
  • Product ID: 704188
  • Duration: 90 Min
This training program will discuss why it is in your interest to conduct a criminal background check, the EEOC’s position on criminal background checks, Ban the Box laws, and how they impact the hiring process.
CD/Recorded
$149
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Recorded/CD
Exporting Marketing Channel Audits

Exporting Marketing Channel Audits

  • Speaker: Rossano V Gerald
  • Product ID: 705341
  • Duration: 60 Min
This training program will address export audit compliance procedures that will emphasize appropriate documentation that are often required in the country market system. The program will also focus on product competitiveness research methods for conducting trade transactions. It will help identify customers, such as the end users, distributors, and sales agents and examine the compliance procedures within foreign law justification. Finally, it will address sales documentation and other record-keeping compliance procedures that should be used by the exporter when dealing with customs for a particular goods requirements for foreign business environment.
CD/Recorded
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