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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
Regulatory Guide for Medicare Claim Management of ADRs (Additional Development Requests)

Regulatory Guide for Medicare Claim Management of ADRs (Additional Development Requests)

  • Speaker: Elisa Bovee
  • Product ID: 705270
  • Duration: 60 Min
This training program will provide an overview of how the interdisciplinary team can successfully navigate through Medicare claim reviews and request for additional developmental requests (ADRs). This course will offer a step by step approach to ensure accurate appropriate reimbursement.
CD/Recorded
$0
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Recorded/CD
FDA vs Health Canada

FDA vs Health Canada

  • Speaker: Rachelle D Souza
  • Product ID: 704862
  • Duration: 60 Min
This webinar will provide an understanding of the organizational hierarchy of FDA and Health Canada, your regulatory and quality compliance obligations and the implications of the interactions between these two agencies on your organization.
CD/Recorded
$0
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Recorded/CD
Regulatory Compliance for Dietary Supplements in the US, EU, and Canada

Regulatory Compliance for Dietary Supplements in the US, EU, and Canada

  • Speaker: Derrick Swint
  • Product ID: 705238
  • Duration: 90 Min
This training program will offer an understanding of how dietary supplements are regulated differently in the US, EU, and Canada, with a focus on challenges and opportunities in each of these regions. The course will provide an overview of the regulatory agencies that govern requirements within each region and the role that each agency plays in setting and enforcing rules for dietary supplements.
CD/Recorded
$0
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Recorded/CD
How to Transfer Non-Compendial and Developed QC Procedures - ICH and USP Guidelines

How to Transfer Non-Compendial and Developed QC Procedures - ICH and USP Guidelines

  • Speaker: Barbara Berglund
  • Product ID: 701845
  • Duration: 90 Min
This webinar will explain ICH and USP guidelines for validation and how to apply ICH guidelines for method transfer and how to establish boundaries.
CD/Recorded
$219
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Recorded/CD
Developing a Formal First Aid, CPR, AED Training Plan

Developing a Formal First Aid, CPR, AED Training Plan

  • Speaker: Joe Keenan
  • Product ID: 705264
  • Duration: 90 Min
This webinar will discuss the importance of developing a formalized first aid, CPR, and AED training plan. It will review OSHA standards for emergency response and offer guidelines for first aid, CPR and AED administration.
CD/Recorded
$179
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Recorded/CD
Legal and Practical Guidelines for Dealing with Psychiatric Disabilities at Work

Legal and Practical Guidelines for Dealing with Psychiatric Disabilities at Work

  • Speaker: Janette Levey Frisch
  • Product ID: 705103
  • Duration: 90 Min
The Americans with Disabilities Act requires employers to provide reasonable accommodations to qualified individuals with disabilities, including those with psychiatric impairments that substantially limit their major life activities. This webinar will discuss an employer’s responsibilities in the workplace and help you take your first steps toward preventing tragedy, ensuring a productive, engaged workforce and safe workplace, and that you are protected against legal liability.
CD/Recorded
$249
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Recorded/CD
Creating and Maintaining an Effective and Efficient Technical Training Programs

Creating and Maintaining an Effective and Efficient Technical Training Programs

  • Speaker: Ginette M Collazo
  • Product ID: 704373
  • Duration: 90 Min
This training program will analyze key elements of training programs in regulated environment. It will also list key performance indicators related to training and offer best practices for developing technical training programs to improve their effectiveness.
CD/Recorded
$249
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Recorded/CD
OASIS-C2 - Home Healthcare; Quality Measures and their Impact in 2017

OASIS-C2 - Home Healthcare; Quality Measures and their Impact in 2017

  • Speaker: Laura S Hargraves
  • Product ID: 705140
  • Duration: 75 Min
This OASIS-C2 webinar will review the new proposed measures, how they work and how to correctly document the data to ensure better outcomes and better rating for your organization.
CD/Recorded
$0
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Recorded/CD
Understanding the Basics of the FDA's New Labeling Requirements

Understanding the Basics of the FDA's New Labeling Requirements

  • Speaker: Derrick Swint
  • Product ID: 705235
  • Duration: 90 Min
The online training will offer food manufacturers a 360 degree approach to food nutritional labeling from a past, present, and future perspective.
CD/Recorded
$0
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Recorded/CD
Exporting to Canada Procedures and Documentation

Exporting to Canada Procedures and Documentation

  • Speaker: Jan Seal
  • Product ID: 703136
  • Duration: 90 Min
This training on export compliance will help you understand documentation and procedures to assist in expediting clearance of commercial goods through Canada Border Services Agency.
CD/Recorded
$149
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Recorded/CD
Bio-Relevant Drug Dissolution Testing: A New Simple and Practical Approach

Bio-Relevant Drug Dissolution Testing: A New Simple and Practical Approach

  • Speaker: Saeed Qureshi
  • Product ID: 705256
  • Duration: 120 Min
This training program will highlight the current difficulties in conducting the dissolution tests, and then providing a simple and practical solution so that products could be evaluated appropriately and efficiently.
CD/Recorded
$279
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Recorded/CD
TSCA Awareness Program for 2017

TSCA Awareness Program for 2017

  • Speaker: Joe Keenan
  • Product ID: 705251
  • Duration: 90 Min
This training program will clearly define all requirements of the Toxic Substance Control Act (TSCA). It will discuss best practices for developing TSCA written plans and TSCA training plans, as well as breakdown all components of the TSCA.
CD/Recorded
$199
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Recorded/CD
Medical Device vs. Consumer Device: Leveraging Technology to Help Patients and Caregivers

Medical Device vs. Consumer Device: Leveraging Technology to Help Patients and Caregivers

  • Speaker: Tom Kramer
  • Product ID: 705223
  • Duration: 60 Min
This training program will provide an understanding of key areas of design focus for medical wearables. Attendees will learn best practices to implement product development plan that apply to medical devices.
CD/Recorded
$0
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Recorded/CD
3-Hour Virtual Training: Lean and the Manufacturing Process

3-Hour Virtual Training: Lean and the Manufacturing Process

  • Speaker: Charles H Paul
  • Product ID: 705229
  • Duration: 180 Min
Lean implementation is not confined to just manufacturing. It can be appropriately applied throughout the organization in all functions. This virtual training program, however, focuses on manufacturing, where lean was born. The difference between this treatment of lean application and others is that we have imbedded the concept of GMP and compliance into our lean model to make it particularly applicable to the life sciences.
CD/Recorded
$0
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Recorded/CD
Good Manufacturing Practices (GMPs) for Phase I Investigational Drugs / Clinical Studies

Good Manufacturing Practices (GMPs) for Phase I Investigational Drugs / Clinical Studies

  • Speaker: Peggy Berry
  • Product ID: 705255
  • Duration: 90 Min
This webinar will help attendees understand differences between GMP requirements for early and later stage clinical development. It will explore and discuss ways to develop and implement strategies for early GMPs for phase I clinical studies.
CD/Recorded
$0
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Recorded/CD
UDI in the EU – A Preliminary Look

UDI in the EU – A Preliminary Look

  • Speaker: Daniel O Leary
  • Product ID: 704854
  • Duration: 90 Min
Many companies offer their devices in the EU, so must comply with the EU UDI regulations. There are significant differences from the US system. While some details remain, there is sufficient information to allow companies to start planning. This webinar can help you prepare for this major aspect of the new EU regulations.
CD/Recorded
$279
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Recorded/CD
Cardiology Mid-Year Coding Update 2017

Cardiology Mid-Year Coding Update 2017

  • Speaker: Terry Fletcher
  • Product ID: 705208
  • Duration: 60 Min
Cardiology Coding 2017, mid-year update. We will cover in office diagnostics, to include any updated rules on EKGs, Holters, Stress Tests. Look at the new coding for 2017 Moderate Sedation Codes, and how they have impacted the first half of 2017. This webinar will also discuss on the new E/M symbols, rules, and new codes and deleted symbols that will impact provider reimbursement, for Cardiology services.
CD/Recorded
$249
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Recorded/CD
The Canadian Food Label

The Canadian Food Label

  • Speaker: Derrick Swint,Abdesselam Benlembarek
  • Product ID: 705209
  • Duration: 90 Min
The food label is one of the most important tools Canadian consumers can use to make informed choices about healthy and safe foods. Canadian food legislation has specific requirements for food manufacturers regarding what to include on a food label and how it should be presented. This course will review the basic requirements of the Canadian Food label, including requirements for the location and size of the common name, net quantity declaration, list of ingredients and allergen labeling, identity and principal place of business, date markings, nutritional labeling, bilingual requirements, irradiation, and sweeteners. For manufacturers of food products for consumption in Canada wishing to ensure compliance to the latest nutritional labeling standard, this course offers an overview of the necessary elements to ensure compliance.
CD/Recorded
$229
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Recorded/CD
Food Safety and Quality Management - Effective Incident Tracking

Food Safety and Quality Management - Effective Incident Tracking

  • Speaker: Felix Amiri
  • Product ID: 705204
  • Duration: 2.5 hrs
This Food Safety and Quality Management training will provide guidance on methods for conducting effective incident tracking. Attendees will learn how to analyze and utilize incident tracing information and data to the benefit of your food business.
CD/Recorded
$0
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Recorded/CD
Medical Device Cybersecurity Following New FDA Guidance

Medical Device Cybersecurity Following New FDA Guidance

  • Speaker: Edwin Waldbusser
  • Product ID: 705200
  • Duration: 60 Min
This training will discuss the final guidance on postmarket management of cybersecurity in medical devices which was released in Dec. 2016. Attendees will learn how to establish a risk-based framework for assessing when changes to medical devices for cybersecurity vulnerabilities require reporting to the FDA.
CD/Recorded
$179
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