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 ›  Documentation and Policy Management

Documentation and Policy Management Training - Live Webinars, Recordings & CDs

Learn the standards for documentation and management, maintain consistency with common law, regulatory requirements, ethical and current best practice requirements. On this page, browse a broad range of courses specially designed for you.
Loading....
Recorded/CD
What are DHF, DMR and DHR? - The FDA Quality Systems Regulations Records Explained

What are DHF, DMR and DHR? - The FDA Quality Systems Regulations Records Explained

  • Speaker: Vinny Sastri
  • Product ID: 701057
  • Duration: 85 Min
This Webinar will describe, explain and clarify the differences between DHF, DMR and DHR . It will also detail the requirements and the expected contents of each record.
CD/Recorded
$349
View Details
Recorded/CD
Selection and Use of (Certified) Reference Material- Strategies for FDA Compliance and Tools for Implementation

Selection and Use of (Certified) Reference Material- Strategies for FDA Compliance and Tools for Implementation

  • Speaker: Dr. Ludwig Huber
  • Product ID: 700900
  • Duration: 80 Min
This Webinar will highlight the requirements of ISO 17025 and ISO 34 and explain the preparation, testing of certified reference materials along with assessment of suppliers of reference materials.
CD/Recorded
$399
View Details
Recorded/CD
Excel Spreadsheets and FDA Device Regulations

Excel Spreadsheets and FDA Device Regulations

  • Speaker: Daniel O Leary
  • Product ID: 701271
  • Duration: 60 Min
This Spread Sheet Validation training/ webinar explains FDA requirements for Excel spreadsheets used in production or the quality system. The regulations come from 21 CFR §820.70(i) Automated Processes and 21 CFR Part 11.
CD/Recorded
$399
View Details
Recorded/CD
Introduction to disaster/emergency management and business continuity programs

Introduction to disaster/emergency management and business continuity programs

  • Speaker: Bill Greulich
  • Product ID: 701337
  • Duration: 60 Min
This Risk management training module will describe a common set of criteria for disaster/emergency management and business continuity programs.
CD/Recorded
$199
View Details
Recorded/CD
W-2 and W-4 Update and Best Practices

W-2 and W-4 Update and Best Practices

  • Speaker: Miles Hutchinson
  • Product ID: 704333
  • Duration: 90 Min
This webinar will prepare your staff for this filing year, improve your employee reporting set-up and maintenance practices, and reduce your risk of complaints from the IRS. Learn the latest updates on Form W-4 and Form W-2 wage and withholding reporting.
CD/Recorded
$0
View Details
Recorded/CD
How To Create an Effective Export Control Compliance Program under the Export Administration Regulations in 2023

How To Create an Effective Export Control Compliance Program under the Export Administration Regulations in 2023

  • Speaker: Douglas Cohen
  • Product ID: 703983
  • Duration: 60 Min
This training program will assist attendees in establishing and enhancing an export compliance program and offer best practices for export compliance given under the Export Administration Regulations (EARs).
CD/Recorded
$0
View Details
Recorded/CD
Japanese PAL - JPAL QMS requirements in Ordinance 169 and differences to ISO 13485

Japanese PAL - JPAL QMS requirements in Ordinance 169 and differences to ISO 13485

  • Speaker: Phil Smart
  • Product ID: 701290
  • Duration: 90 Min
This JPAL (Japanese Pharmaceutical Affairs Law) QMS training/webinar will explore, in detail, the QMS requirements placed on the foreign manufacturer via Ministerial Ordinance 169, Ordinance 2 and Ordinance 179.
CD/Recorded
$299
View Details
Recorded/CD
Good Laboratory Practices (GLP): Documenting Deviations & Unexpected Circumstances

Good Laboratory Practices (GLP): Documenting Deviations & Unexpected Circumstances

  • Speaker: Celeste Rose
  • Product ID: 701246
  • Duration: 60 Min
This Good Laboratory Practice training defines deviations and unexpected events, the similarities and differences between deviations and amendments, and will present strategies to minimize the occurrence of unnecessary deviations.
CD/Recorded
$249
View Details
Recorded/CD
Use of Spreadsheets to Report Data in FDA Regulated Industries

Use of Spreadsheets to Report Data in FDA Regulated Industries

  • Speaker: Robert Ferer
  • Product ID: 701298
  • Duration: 60 Min
This Spreadsheet validation training will cover the use of spreadsheets to report data from the inception of the spreadsheet (user requirement specification), through the development process, validation, and use.
CD/Recorded
$299
View Details
Recorded/CD
Japanese PAL - Dealing with a JPAL Quality Interface Agreement between the foreign manufacturer and MAH (Marketing Authorization Holder)

Japanese PAL - Dealing with a JPAL Quality Interface Agreement between the foreign manufacturer and MAH (Marketing Authorization Holder)

  • Speaker: Phil Smart
  • Product ID: 701277
  • Duration: 90 Min
This JPAL training will describe requirements, common mistakes & best practices while dealing with a JPAL Quality Interface Agreement between the foreign manufacturer and MAH (Marketing Authorization Holder).
CD/Recorded
$299
View Details
Recorded/CD
What are best practices for creating a Risk Management File?

What are best practices for creating a Risk Management File?

  • Speaker: Dennis Moore
  • Product ID: 701233
  • Duration: 60 Min
This Quality management training will review processes for integrating a reasonable level of risk management into the quality management system.
CD/Recorded
$299
View Details
Recorded/CD
How to conduct a Clinical Trial in accordance with FDA regulations and how to avoid the common deficiencies observed during FDA clinical audits

How to conduct a Clinical Trial in accordance with FDA regulations and how to avoid the common deficiencies observed during FDA clinical audits

  • Speaker: Elizabeth Bergan
  • Product ID: 701054
  • Duration: 90 Min
This Clinical Trial training will provide a detailed review of the FDA regulations for Clinical Trials Process. This presentation will provide a detailed review of the FDA regulations for Clinical Trials Process. After attending this session, participants will have an understanding of FDA regulations pertaining to the implementation of clinical trials and concepts of Good Clinical Practice (GCP) and Bioethics.
CD/Recorded
$199
View Details
Recorded/CD
510(k) Applications made Simple

510(k) Applications made Simple

  • Speaker: E.J Smith
  • Product ID: 701082
  • Duration: 60 Min
This 510(k) Training covers the content requirements of a traditional 510(k) application and covers in detail the recommended 20 sections. This 510(k) Training deals only with those medical devices that require a 510(k) application. All Manufacturers introducing Class II medical devices to the US market must submit a FDA 510(k). It is also required for manufacturers that are changing the intended use of the medical device, or changing the technology of a cleared device such a way that it may significantly affect its safety or effectiveness.
CD/Recorded
$299
View Details
Recorded/CD
Basics of Writing Validation Protocols for Medical Devices

Basics of Writing Validation Protocols for Medical Devices

  • Speaker: Lawrence Spritzer
  • Product ID: 701099
  • Duration:
This Medical Device training will describe the information needed to write such protocols, and the basic contents of those protocols. This webinar will provide valuable assistance to all regulated companies that need to validate their manufacturing processes.
CD/Recorded
$249
View Details
Recorded/CD
Documenting & Conducting CAPA Investigations

Documenting & Conducting CAPA Investigations

  • Speaker: Nathan Conover
  • Product ID: 701038
  • Duration: 60 Min
This CAPA training provides a process to overcome challenges for Documentation and Conducting CAPA Investigations and integrates FDA requirements and guidelines. "Failure to employ effective CAPA systems can lead to FDA Warning Letters and worse. Accurate documentation is a must – but capturing information from a diverse workforce can be very difficult. Do you have what it takes to meet these challenges?".

Fact: The FDA has noted that 76% of all Warning Letters have CAPA-related issues. This is a significantly large percentage – the results of companies doing a bad job of identifying corrective and preventive actions as well as not validating plan effectiveness.

CD/Recorded
$249
View Details
Recorded/CD
Deploying Regulatory-Compliant Clinical Research Data Management Systems

Deploying Regulatory-Compliant Clinical Research Data Management Systems

  • Speaker: Dale Hunscher
  • Product ID: 701068
  • Duration: 60 Min
This presentation covers the fundamental principles underlying the various compliance regulations and discusses their implications for system designers and integrators. Electronic data capture and management systems for clinical research must support many kinds of research, including clinical trials, prospective observational studies, and retrospective "chart mining". Regulatory requirements for new drug and device trials are the most stringent and complex, but even the smallest investigator-initiated study in an academic health center or community hospital or clinic must comply with human subject protection regulations and professional ethical guidelines, and meet information security requirements such as the HIPAA Privacy and Security Rules. This presentation covers the fundamental principles underlying the various compliance regulations and discusses their implications for system designers and integrators.
CD/Recorded
$249
View Details
Recorded/CD
Effective Records, Document Control, and SOPs

Effective Records, Document Control, and SOPs

  • Speaker: Nick Campbell
  • Product ID: 701020
  • Duration: 60 Min
We will discuss methods and practices that will improve the clarity and control of your document control system. Effective GMP documentation practices will be reviewed to ensure your paperwork is clear, complete, and easy to understand.
CD/Recorded
$0
View Details
Recorded/CD
Using Electronic Health Records and Claims Databases for Rapid-Response Pharmacovigilance Studies

Using Electronic Health Records and Claims Databases for Rapid-Response Pharmacovigilance Studies

  • Speaker: Alan Hochberg
  • Product ID: 700972
  • Duration: 60 Min
This presentation will give an overview of these new tools and techniques for the non-statistician/epidemiologist. It is vital that a pharmaceutical manufacturer be able to quickly assess these issues on a sound statistical basis, in a way that eliminates bias due to confounding factors as much as possible.
CD/Recorded
$299
View Details
Recorded/CD
Getting the Most Out Of Data Mining for Pharmacovigilance and Risk Management

Getting the Most Out Of Data Mining for Pharmacovigilance and Risk Management

  • Speaker: Alan Hochberg
  • Product ID: 700971
  • Duration: 60 Min
This presentation will give an overview of data mining systems, for the safety or regulatory professional who collaborates with data miners, and for the executive decision-maker who oversees the implementation of data mining.
CD/Recorded
$249
View Details
Recorded/CD
Organization of Clinical Datasets in eCTD Submissions

Organization of Clinical Datasets in eCTD Submissions

  • Speaker: Antoinette Azevedo
  • Product ID: 700992
  • Duration: 90 Min
This presentation will review the documentation requirements, the electronic navigation aids required for all the components of the electronic datasets package for a clinical study. This webinar will provide valuable assistance to all pharmaceutical and biotechnology that are conducting clinical studies with the intent of filing Investigational New Drug (IND) and New Drug Applications (NDA) or Biological License Applications (BLA) submissions.
CD/Recorded
$249
View Details
Best Sellers
You Recently Viewed
    Loading
Copyright © 2026 ComplianceOnline.com
MetricStream
Our Policies: Terms of use | Privacy