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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
Clinical Documentation: How to Avoid Documentation Pitfalls in the EMR

Clinical Documentation: How to Avoid Documentation Pitfalls in the EMR

  • Speaker: Dreama Sloan-Kelly
  • Product ID: 704852
  • Duration: 60 Min
This clinical documentation webinar will discuss how to appropriately document in the history, physical exams, and assessment and plan section of the EMR. It will also provide practical tips on designing templates, as well as avoiding common audit pitfalls.
CD/Recorded
$179
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Recorded/CD
FSMA Gives FDA Fee Collection Authority for Certain Violations

FSMA Gives FDA Fee Collection Authority for Certain Violations

  • Speaker: Ralph A Simmons
  • Product ID: 704787
  • Duration: 90 Min
FSMA has modified the traditional position that FDA would not collect fees from food companies to allow collection of the agency’s costs of remedying certain violations of food law. This training program will offer a background on FDA imposition of fees on food producers, the fee amount, and how it applies to small businesses.
CD/Recorded
$199
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Recorded/CD
Overview of Life Cycle of an Analytical Method in Development and Manufacture of Biologics

Overview of Life Cycle of an Analytical Method in Development and Manufacture of Biologics

  • Speaker: Rajesh Gupta
  • Product ID: 704755
  • Duration: 60 Min
This training program will offer an understanding of analytical method life cycle and regulatory expectations and requirements for the methods during product development. The webinar will also analyze risks and inherent variability of analytical methods.
CD/Recorded
$0
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Recorded/CD
Structuring and Implementing Hospital-Physician Call Coverage Arrangements: Strategies for Mitigating Risk

Structuring and Implementing Hospital-Physician Call Coverage Arrangements: Strategies for Mitigating Risk

  • Speaker: Joseph Wolfe
  • Product ID: 704784
  • Duration: 60 Min
Health care organizations should be monitoring and auditing their existing call coverage arrangements to ensure they are compliant with regulatory requirements in case they are challenged. This training session will provide an overview of the Anti-Kickback and Stark Law, including 2016 changes and updates.
CD/Recorded
$0
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Recorded/CD
The Top 10 Forklift Safety Mistakes and How to Prevent Them

The Top 10 Forklift Safety Mistakes and How to Prevent Them

  • Speaker: Michael Aust
  • Product ID: 704788
  • Duration: 60 Min
In this training program, the instructor will discuss case studies on the types of forklift safety mistakes that are found in the workplace. He will also provide strategies on how to actively engage your workforce to improve the safety culture of your workforce.
CD/Recorded
$199
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Recorded/CD
Preparation for GMP Inspections by Regulatory Agencies

Preparation for GMP Inspections by Regulatory Agencies

  • Speaker: Peggy Berry
  • Product ID: 704843
  • Duration: 90 Min
This GMP inspections webinar will review what to expect during the agency inspection and how to successfully and efficiently streamline and manage the inspection, including adequate follow-up during and after the inspection.
CD/Recorded
$0
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Recorded/CD
Comparing the Pharmaceutical and Medical Device Product Lifecycles

Comparing the Pharmaceutical and Medical Device Product Lifecycles

  • Speaker: Howard Cooper
  • Product ID: 704853
  • Duration: 120 Min
This webinar will help you gain a greater understanding of regulatory and compliance requirements and how the early product lifecycle requirements establish the basic groundwork as a foundation from product development to commercialization continuing to out commercialization and product discontinuation.
CD/Recorded
$249
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Recorded/CD
Successful 3PL Relationships - Managing with Service Level Agreements and Key Performance Indicators

Successful 3PL Relationships - Managing with Service Level Agreements and Key Performance Indicators

  • Speaker: Joe Lynch
  • Product ID: 704783
  • Duration: 60 Min
This training program will explore how using service level agreements along with key performance properly will enable a shipper to drive continuous improvement in their supply chain. SLAs and KPIs will also ensure that agreed to, objective measurements are being used to judge 3PL performance. An SLA along with the proper KPIs will allow shippers to create incentives, disincentives and exit clauses based on performance.
CD/Recorded
$199
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Recorded/CD
Lyophilization: What you Need to Know, Validation and Regulatory Approaches

Lyophilization: What you Need to Know, Validation and Regulatory Approaches

  • Speaker: John R Godshalk
  • Product ID: 704845
  • Duration: 60 Min
In this webinar, attendees will learn how lyophilization cycles are developed, how lyophilizers work and how they are controlled and what is important to FDA and other regulatory bodies in the inspection of lyophilizers and in the validation process.
CD/Recorded
$0
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Recorded/CD
Mission Possible Series 4: Making Safety Training Fun, Effective, Goal Oriented and Measuring Effectiveness

Mission Possible Series 4: Making Safety Training Fun, Effective, Goal Oriented and Measuring Effectiveness

  • Speaker: Michael Aust
  • Product ID: 704775
  • Duration: 60 Min
This webinar will discuss the strategy to conduct safety trainings and provide practical methods and techniques to make safety trainings more effective, educational and entertaining. Instructor will explain how to make trainings interactive, engaging and deliver required results and how to measure effectiveness.
CD/Recorded
$0
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Recorded/CD
4-Hr Virtual Training: Key Factors to Write an Effective Standard Operating Procedure and Work Instructions

4-Hr Virtual Training: Key Factors to Write an Effective Standard Operating Procedure and Work Instructions

  • Speaker: Joy McElroy
  • Product ID: 704778
  • Duration: 4 hrs
This training program will guide attendees in writing effective Standard Operating Procedures and Work Instructions. It will also discuss how to assess and write to the audience and how to review and revise SOPs and Work Instructions.
CD/Recorded
$0
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Recorded/CD
Compliance with Canadian Quality Management System Regulatory Requirements

Compliance with Canadian Quality Management System Regulatory Requirements

  • Speaker: Edward Kimmelman
  • Product ID: 704726
  • Duration: 90 Min
The training program will provide insight into complying with the key QMS requirements for organizations selling medical devices in Canada.
CD/Recorded
$279
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Recorded/CD
Institutional Review Boards (IRBs): The Changing Landscape and the Effect on the Conduct of Clinical Research

Institutional Review Boards (IRBs): The Changing Landscape and the Effect on the Conduct of Clinical Research

  • Speaker: Sarah Fowler Dixon
  • Product ID: 703400
  • Duration: 60 Min
This clinical research training will explain the Institutional Review Board (IRB) models. It will discuss the regulatory framework for IRB review including 21 CFR 50, 56 and 45 CFR 46.
CD/Recorded
$229
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Recorded/CD
"I Work Alone": Limiting Liability Concerning Independent Contractor Status

"I Work Alone": Limiting Liability Concerning Independent Contractor Status

  • Speaker: Jacquiline M Wagner
  • Product ID: 704772
  • Duration: 90 Min
This training program will explain how we ascertain the difference between circumstances in which a service provider is an employee (and a principal is an employer) and circumstances in which the service provider is an independent contractor (and the principal is a client).
CD/Recorded
$0
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Recorded/CD
Data Management in Clinical Research

Data Management in Clinical Research

  • Speaker: Kesley Tyson
  • Product ID: 704768
  • Duration: 60 Min
This training program will identify regulations and guidelines pertaining to data management in clinical research. Attendees will learn to translate the regulations and guidelines into practical application for each stage of the clinical trial: start-up, ongoing study management, and study closure. The program will also discuss the do’s/don’t for data management activities through real-life examples.
CD/Recorded
$0
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Recorded/CD
OSHA Required Training Topics for General Industry

OSHA Required Training Topics for General Industry

  • Speaker: Michael Aust
  • Product ID: 704555
  • Duration: 60 Min
This webinar will help you identify required, minimum safety training requirements under OSHA and 29 CFR 1910 for General Industry organizations. Participants will understand trainer requirements for providing instruction on safety topics. The Instructor will discuss the frequency of training topics required and will explain the training matrix.
CD/Recorded
$0
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Recorded/CD
How to Build Effective Metrics for Vendor Oversight

How to Build Effective Metrics for Vendor Oversight

  • Speaker: Beat Widler
  • Product ID: 704766
  • Duration: 60 Min
This training program will explain what the critical areas and elements of vendor oversight are and how you can set such a system up for yourself at your company.
CD/Recorded
$50
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Recorded/CD
Understanding and Applying Best Practice Standards When Reviewing Clinical Research Contracts

Understanding and Applying Best Practice Standards When Reviewing Clinical Research Contracts

  • Speaker: Jennifer Holcomb
  • Product ID: 704337
  • Duration: 60 Min
This training program will take an in-depth look at various clinical research contracts designed for different purposes. Understanding each type including what is being protected and who is being protected is an important part of ensuring compliant administration and management of clinical research activities. Beyond the legal terms, this course will examine the standards for accredited organizations and best practices for ensuring the broadest protections for study participants.
CD/Recorded
$249
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Recorded/CD
Fitting the Concepts of Enterprise Risk Management to Your Organization

Fitting the Concepts of Enterprise Risk Management to Your Organization

  • Speaker: Lynn Fountain
  • Product ID: 704763
  • Duration: 90 Min
This training program will explore standard stated benefits of ERM including increased competitive advantage, increased likelihood of achieving strategic objectives and ability to meet increased stakeholder expectations, improved governance and increased likelihood of meeting regulatory and compliance expectations.
CD/Recorded
$179
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Recorded/CD
Hazardous Waste Regulation: 10 Major Differences Between Federal RCRA and California Hazardous Waste Regulations

Hazardous Waste Regulation: 10 Major Differences Between Federal RCRA and California Hazardous Waste Regulations

  • Speaker: James T. Dufour
  • Product ID: 701875
  • Duration: 90 Min
This training program will offer a comparison of RCRA and California hazardous waste characterization. It will detail the enactment of the California Hazardous Waste Control Law in 1972 before RCRA in 1976. The course will also discuss permits required to treat most hazardous wastes that would be exempt from permitting under RCRA.
CD/Recorded
$149
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