ComplianceOnline
Join for Free
Signin
Welcome back! Please log in below to continue.
Forgot Password?
New customer? Free Signup
Your Shopping Cart
Contains 0 items
Total: $0.00
View Shopping Cart
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!
Loading....
Recorded/CD
Batch Production Record (BPR) and Device History Record (DHR) Review and Quality Assessment

Batch Production Record (BPR) and Device History Record (DHR) Review and Quality Assessment

  • Speaker: Jerry Dalfors
  • Product ID: 703560
  • Duration: 90 Min
This webinar will provide the typical elements required to be included in the Batch Production Record and the Device History Record in order to accomplish a quality and cost effective review and quality assessment based on current regulatory expectations.
CD/Recorded
$229
View Details
Recorded/CD
FDA Regulation of Tobacco Products: The Deeming Regulation - Impact on E-Cigarettes

FDA Regulation of Tobacco Products: The Deeming Regulation - Impact on E-Cigarettes

  • Speaker: Azim Chowdhury
  • Product ID: 703107
  • Duration: 60 Min
This webinar on tobacco regulations will discuss FDA regulatory requirements for tobacco products. It will prepare you for FDA’s Deeming Regulations for cigars, pipe tobacco, electronic cigarettes, dissolvable tobacco and other novel tobacco products.
CD/Recorded
$249
View Details
Recorded/CD
ISO 22000 vs GFSI (SQF, BRC, IFS, and FSSC 22000): Meeting key Requirements

ISO 22000 vs GFSI (SQF, BRC, IFS, and FSSC 22000): Meeting key Requirements

  • Speaker: Mark Kruk
  • Product ID: 703557
  • Duration: 60 Min
This webinar will focus on ISO 22000 Food Safety Management System and its comparison to the Global Food Safety Initiative (GFSI) Standard. It will provide an overview of key requirements and will discuss differences and similarities between both the approaches. It will also address key strategic business factors to consider when selecting a particular approach.
CD/Recorded
$229
View Details
Recorded/CD
Multistate Handbooks: Multitasking Policies Effectively

Multistate Handbooks: Multitasking Policies Effectively

  • Speaker: Deirdre Kamber Todd
  • Product ID: 703528
  • Duration: 60 Min
This webinar will explain how to develop and maintain a high-quality multi-state employee handbook. It will cover common federal and state issues in multistate handbook drafting including NLRB, EEOC, PPACA, disability, pregnancy and leave.
CD/Recorded
$149
View Details
Recorded/CD
Introduction of Post-Marketing Drug Safety Surveillance: Pharmacovigilance in FDA / CDER

Introduction of Post-Marketing Drug Safety Surveillance: Pharmacovigilance in FDA / CDER

  • Speaker: David Lilienfeld
  • Product ID: 703479
  • Duration: 90 Min
This pharmacovigilance webinar will provide attendees an understanding of post-marketing drug safety surveillance, its role in lifecycle management, and the practices and regulations governing its conduct. It will describe the structure of the pharmacovigilance world including the ICH, the FDA, CIOMS, MHW, and EudraVigilance.
CD/Recorded
$229
View Details
Recorded/CD
Steps to Design and Develop an Effective Closed Loop Change Control System

Steps to Design and Develop an Effective Closed Loop Change Control System

  • Speaker: Michael Kagan
  • Product ID: 703489
  • Duration: 90 Min
This webinar will discuss how to design an effective change control system – electronic as well as paper-based – with traceability and closed loop verification built into the process.
CD/Recorded
$229
View Details
Recorded/CD
Ensuring Legally-Effective Informed Consent: Basic to Advanced Issues for Investigators and IRBs

Ensuring Legally-Effective Informed Consent: Basic to Advanced Issues for Investigators and IRBs

  • Speaker: George Gasparis
  • Product ID: 703562
  • Duration: 90 Min
This webinar on informed consent will review the regulatory requirements to ensure that legally-effective consent is obtained for enrollment of subjects in human research regulated by the Department of Health and Humans Services (HHS) and/or the Food and Drug Administration (FDA). You will gain an understanding of not only the basic requirements, but also several challenging areas to ensure legally-effective consent.
CD/Recorded
$229
View Details
Recorded/CD
Current Issues in the Regulation of Dietary Supplements

Current Issues in the Regulation of Dietary Supplements

  • Speaker: Eric B Alspaugh
  • Product ID: 703556
  • Duration: 90 Min
This webinar will explain FDA regulations and current good manufacturing practices (cGMPs) for dietary supplements. Attendees will learn how to comply with these regulations and avoid enforcement actions.
CD/Recorded
$229
View Details
Recorded/CD
Transforming the Cargo Clearance Process

Transforming the Cargo Clearance Process

  • Speaker: Suzanne Richer
  • Product ID: 703264
  • Duration: 60 Min
This Customs and Border Protection compliance training will help the attendees understand the latest CBP developments relating to the entire cargo clearance process and how these will impact import clearances.
CD/Recorded
$149
View Details
Recorded/CD
Changes in US FDA Enforcement

Changes in US FDA Enforcement

  • Speaker: Edwin L Bills
  • Product ID: 701699
  • Duration: 90 Min
This FDA compliance training will discuss major changes in FDA enforcement and how the regulated industry should respond to any FDA inspection activity.
CD/Recorded
$229
View Details
Recorded/CD
Current Trends in FDA Inspections

Current Trends in FDA Inspections

  • Speaker: Michael Ferrante
  • Product ID: 703485
  • Duration: 90 Min
This webinar will focus on the current trends in FDA inspections and guidelines that can be implemented to ensure compliance with the latest quality and regulatory requirements. Attendees will learn how to prepare for an FDA inspection to avoid Warning Letters.
CD/Recorded
$229
View Details
Recorded/CD
How to Discipline and Discharge a Poor-Performing Employee Where a workers' compensation Claim has been Filed: Avoiding Retaliatory Discharge Lawsuits

How to Discipline and Discharge a Poor-Performing Employee Where a workers' compensation Claim has been Filed: Avoiding Retaliatory Discharge Lawsuits

  • Speaker: Jeffrey Weintraub
  • Product ID: 703503
  • Duration: 60 Min
This webinar will explain how to discharge a poor-performing employee where a workers’ compensation claim has been filed. Attendees will learn how to minimize the risks of retaliatory discharge lawsuits when taking adverse action against these kinds of employees.
CD/Recorded
$149
View Details
Recorded/CD
Understanding CFR Part 210-211 Requirements for Drug Products

Understanding CFR Part 210-211 Requirements for Drug Products

  • Speaker: Jamie Jamshidi
  • Product ID: 700931
  • Duration: 90 Min
This webinar will discuss in detail all parts of the regulations set forth in part 210 and in parts 211 of 21 CFR chapters. Attendees will learn how to comply with these regulations.
CD/Recorded
$229
View Details
Recorded/CD
OSHA Laboratory Standard

OSHA Laboratory Standard

  • Speaker: Randall Charpentier
  • Product ID: 703510
  • Duration: 90 Min
This webinar will provide an overview of OSHA chemical hygiene plan. It will discuss requirements of OSHA’s occupational exposure to hazardous chemicals in the Laboratory Standard (29 CFR 1910.1450), including labeling requirements.
CD/Recorded
$149
View Details
Recorded/CD
Supplier Qualification Audit, A Risk Based Approach

Supplier Qualification Audit, A Risk Based Approach

  • Speaker: Yasamin Ameri
  • Product ID: 703477
  • Duration: 60 Min
This webinar will discuss requirements for supplier and vendor qualifications. Attendees will learn how to develop a risk management plan for monitoring of suppliers, vendors and service providers. It will also discuss how to prevent recalls and advisory notices due to provided non-conforming materials or bad services.
CD/Recorded
$229
View Details
Recorded/CD
FDA Guidance: Medical Device Recalls

FDA Guidance: Medical Device Recalls

  • Speaker: Angela Bazigos
  • Product ID: 703473
  • Duration: 90 Min
This webinar will discuss in detail the FDA guidance on medical device recalls including its role, expectations and enforcement policy. It will cover key topics on medical device recall including recall classification, firm’s responsibilities for a recall, recall communication, recall strategy, FDA expectations and much more.
CD/Recorded
$179
View Details
Recorded/CD
Successful Export Controls Compliance: How to Conduct a Thorough Due Diligence for Exports to Sanctioned Countries

Successful Export Controls Compliance: How to Conduct a Thorough Due Diligence for Exports to Sanctioned Countries

  • Speaker: Suzanne Bullitt
  • Product ID: 703282
  • Duration: 60 Min
This export controls compliance training will focus on Office of Foreign Asset Controls (OFAC) regulations. Attendees will learn best practices for managing due diligence processes for their exports when dealing with sanctioned countries.
CD/Recorded
$149
View Details
Recorded/CD
The 510(k) Process and Risk Management

The 510(k) Process and Risk Management

  • Speaker: Edwin L Bills
  • Product ID: 701497
  • Duration: 90 Min
This 510(k) and risk management webinar will discuss FDA expectations for information supplied in the 510(k) application and how to best demonstrate that product is safe.
CD/Recorded
$229
View Details
Recorded/CD
Internal Auditing in Pharmaceutical Manufacturing - Lightning Rod & Steam Valve

Internal Auditing in Pharmaceutical Manufacturing - Lightning Rod & Steam Valve

  • Speaker: Mitchell Ehrlich
  • Product ID: 703465
  • Duration: 60 Min
This webinar will explain how to conduct an effective internal audit program. Attendees will learn the benefits of a well-designed and executed internal auditing program for GMP compliance enhancement, management informatics and for avoidance of whistleblower actions.
CD/Recorded
$229
View Details
Recorded/CD
Responding to Unsolicited Requests for Off-Label Information

Responding to Unsolicited Requests for Off-Label Information

  • Speaker: Mukesh Kumar
  • Product ID: 703464
  • Duration: 90 Min
This webinar will discuss the FDA guidelines for handling unsolicited requests about off-label information. It will provide attendees a list of dos and don’ts related to social media techniques in off-label promotion.
CD/Recorded
$229
View Details
Best Sellers
You Recently Viewed
    Loading
Copyright © 2023 ComplianceOnline.com
MetricStream
Our Policies: Terms of use | Privacy