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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
Pharmaceutical Government Price Reporting: Impact of Obamacare

Pharmaceutical Government Price Reporting: Impact of Obamacare

  • Speaker: Ben Barrameda
  • Product ID: 703286
  • Duration: 60 Min
This webinar on drug price reporting will discuss the changes to the Medicaid Drug Program and its impact on pharmaceutical and biotech companies.
CD/Recorded
$149
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Recorded/CD
Archiving Clinical Trial Documents - Understanding Regulatory Requirements for Paper and Electronic Records

Archiving Clinical Trial Documents - Understanding Regulatory Requirements for Paper and Electronic Records

  • Speaker: Eldin Rammell
  • Product ID: 703265
  • Duration: 60 Min
This webinar will cover regulatory requirements for archiving clinical trial documents, both paper and electronic records. It will focus on the key components of a digital preservation strategy to ensure the ongoing retrievability and accessibility of clinical trial electronic records.
CD/Recorded
$229
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Recorded/CD
Marketing Beverages, Fruit Juice and Sports Drinks in Compliance with FDA Regulations

Marketing Beverages, Fruit Juice and Sports Drinks in Compliance with FDA Regulations

  • Speaker: Anthony Pavel
  • Product ID: 703033
  • Duration: 60 Min
This training on marketing of beverages, fruit juice and sports drinks will focus on FDA’s labeling regulations and requirements, FTC enforcement of advertising claims, and recent developments in consumer class action lawsuits involving beverages. Attendee will learn best practices to ensure compliance with FDA and FTC regulations.
CD/Recorded
$229
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Recorded/CD
Cal/OSHA Inspections and Citations - Proven Strategies for Success

Cal/OSHA Inspections and Citations - Proven Strategies for Success

  • Speaker: Don Dressler
  • Product ID: 703007
  • Duration: 60 Min
This webinar will review recent inspection focus areas by Cal-OSHA inspectors, discuss how you should prepare for the inspection, and demonstrate proven strategies that will help you be successful both during the inspection as well as afterwards if there are violations and citations to deal with.
CD/Recorded
$149
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Recorded/CD
Understanding the FDA ''Refuse to Accept'' guidance to avoid administrative rejection of your 510(k)

Understanding the FDA ''Refuse to Accept'' guidance to avoid administrative rejection of your 510(k)

  • Speaker: Cheryl Wagoner
  • Product ID: 703235
  • Duration: 60 Min
The webinar will familiarize participants with the FDA's Refuse to Accept Policy for medical device 510(k)’s and help you ensure that your 510(k) application is not rejected for lack of administrative completeness.
CD/Recorded
$229
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Recorded/CD
Quality Control for Microbiological Media and Reagents

Quality Control for Microbiological Media and Reagents

  • Speaker: Michael Brodsky
  • Product ID: 703233
  • Duration: 60 Min
The webinar will discuss best QC practices and procedures for verifying the suitability and performance characteristics of microbiological media and reagents.
CD/Recorded
$179
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Recorded/CD
Staying Ahead of the OIG: Best Practices in avoiding Fraud and Abuse and Civil Fines and Penalties

Staying Ahead of the OIG: Best Practices in avoiding Fraud and Abuse and Civil Fines and Penalties

  • Speaker: Alice H Martin,Michael Rosen
  • Product ID: 703231
  • Duration: 75 Min
This webinar will discuss how to review the OIG Strategic Plan for 2014-2018 and recent cases of enforcement in the area of Fraud and Abuse. This session will cover the best practices and a compliance plan that can help you avoid these pitfalls and penalties.
CD/Recorded
$229
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Recorded/CD
Is Your Criminal Background Check Policy Consistent with the EEOC's Updated Guidance?

Is Your Criminal Background Check Policy Consistent with the EEOC's Updated Guidance?

  • Speaker: Kevin Troutman
  • Product ID: 703251
  • Duration: 90 Min
This HR compliance training will provide the attendees tools and procedures for adopting the right background check policy to avoid discrimination claims and lawsuits. It will provide an overview of recent cases brought against employers for improper use of criminal background information.
CD/Recorded
$50
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Recorded/CD
Protecting Inexperienced Workers in Hazardous Industries/Tasks

Protecting Inexperienced Workers in Hazardous Industries/Tasks

  • Speaker: Styron Powers
  • Product ID: 703207
  • Duration: 60 Min
This training on health and safety compliance will provide the attendees best practices for protecting new and experienced employees and contractors in hazardous industries.
CD/Recorded
$50
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Recorded/CD
Social Media Trends, Best Practices and Compliance for Healthcare Professionals

Social Media Trends, Best Practices and Compliance for Healthcare Professionals

  • Speaker: Janet Kennedy
  • Product ID: 703247
  • Duration: 60 Min
This social media training for healthcare professionals will provide attendees best practices to ensure compliance with social media policies and avoid HIPAA violations and the resulting penalties and lawsuits.
CD/Recorded
$229
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Recorded/CD
Medical Foods: Understanding what Constitutes a Medical Food for FDA Regulatory Purposes and Strategies for Successfully Commercializing such Products in the U.S.

Medical Foods: Understanding what Constitutes a Medical Food for FDA Regulatory Purposes and Strategies for Successfully Commercializing such Products in the U.S.

  • Speaker: Karl M. Nobert
  • Product ID: 702508
  • Duration: 90 Min
This training on medical foods will provide an introduction to FDA’s regulation of medical products, assist you in identifying when it may be appropriate to market a product as a medical food; recommend strategies for marketing such products; and summarize recent FDA enforcement actions in the area to help companies mitigate the risk of potential Agency enforcement action.
CD/Recorded
$229
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Recorded/CD
Legal Writing Skills to Prepare for Effective Regulatory Submissions - FDA, EU EMEA and EU Notified Body

Legal Writing Skills to Prepare for Effective Regulatory Submissions - FDA, EU EMEA and EU Notified Body

  • Speaker: Bob Michalik, JD, RAC Michalik
  • Product ID: 700691
  • Duration: 60 Min
This training on legal writing for regulatory submissions will provide practical tips that have proven to enhance the persuasiveness of regulatory submissions and help you succeed even if some of your test results or other supporting information are lacking.
CD/Recorded
$50
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Recorded/CD
Risk Factors in EEOC Compliance

Risk Factors in EEOC Compliance

  • Speaker: Bob McKenzie
  • Product ID: 703224
  • Duration: 60 Min
This training will discuss how to comply with Equal Employment Opportunity Laws, EEOC's investigative tactics and enforcement and what you can do to avoid discrimination charges.
CD/Recorded
$149
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Recorded/CD
How to Audit the ERM function

How to Audit the ERM function

  • Speaker: Denise Cicchella
  • Product ID: 703240
  • Duration: 60 Min
This training will provide the attendees best practices for auditing the Enterprise Risk Management function. Learn the role and importance of audit in maintaining the effectiveness of ERM program.
CD/Recorded
$149
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Recorded/CD
Driving Quality and Compliance in Drug Development Through the FDA End-of-Phase 2A Meeting

Driving Quality and Compliance in Drug Development Through the FDA End-of-Phase 2A Meeting

  • Speaker: Roger Toothaker
  • Product ID: 703214
  • Duration: 60 Min
This training on FDA compliance will provide the attendees with an understanding of FDA expectations regarding end-of-phase 2A meeting guidance. Attendees will learn the best practices to comply with the intent of the guidance and to achieve a higher quality outcome from the meeting.
CD/Recorded
$229
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Recorded/CD
Essentials of the Trial Master File for Pharmaceutical, Biotech, Medical Device and Diagnostics Industries and Paper vs. Electronic TMFs - Which is Correct for My Program

Essentials of the Trial Master File for Pharmaceutical, Biotech, Medical Device and Diagnostics Industries and Paper vs. Electronic TMFs - Which is Correct for My Program

  • Speaker: Adam Ruskin
  • Product ID: 703210
  • Duration: 90 Min
This training on clinical compliance will focus on the requirements of trial master file (TMF) for pharmaceutical product, biotech, a medical device or a diagnostic product. Attendees will learn the best practices to ensure that the TMF is ready for inspection by the regulatory authority.
CD/Recorded
$229
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Recorded/CD
US FDA 510(k): Best Practices for 510(k) Preparation and Submission

US FDA 510(k): Best Practices for 510(k) Preparation and Submission

  • Speaker: David Lim
  • Product ID: 703218
  • Duration: 60 Min
This webinar will discuss best practices for premarket notification [510(k)] preparation and submission compliant with FDA's eCopy and Refuse to Accept (RTA) Policy requirements.
CD/Recorded
$229
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Recorded/CD
Bacterial Contamination in a Product Facility

Bacterial Contamination in a Product Facility

  • Speaker: Richard Anfuso
  • Product ID: 703217
  • Duration: 60 Min
This training on food safety compliance will provide the attendees with the knowledge of how food borne pathogens enter a food plant, expand its presence within the facility and contaminate the products. Attendees will learn the best practices for minimizing the presence of these pathogens in the food plant.
CD/Recorded
$149
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Recorded/CD
Drug Master Files: New Requirements under GDUFA

Drug Master Files: New Requirements under GDUFA

  • Speaker: Camille Davis Thornton
  • Product ID: 703209
  • Duration: 60 Min
This training on Generic Drug User Fee Amendments of 2012 will discuss the new requirements under GDUFA and effect of GDUFA on the Drug Master File (DMF) process.
CD/Recorded
$229
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Recorded/CD
Navigating and Negotiating HIPAA Business Associate Agreements

Navigating and Negotiating HIPAA Business Associate Agreements

  • Speaker: Amy Fehn
  • Product ID: 703208
  • Duration: 60 Min
This training on HIPAA compliance will discuss the modifications made to the Final Omnibus Rule and the impact of these changes on agreements between covered entities and business associates. Attendees will learn best practices for developing and negotiating new business associate agreements.
CD/Recorded
$229
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