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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.
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Recorded/CD
Adverse Event Reporting Requirements for Dietary Supplements and OTC Drugs

Adverse Event Reporting Requirements for Dietary Supplements and OTC Drugs

  • Speaker: Mukesh Kumar
  • Product ID: 703422
  • Duration: 90 Min
This webinar will discuss regulatory requirements for adverse event reporting for dietary supplements and OTC products. It will explain the similarities and differences in reporting adverse events for dietary supplements and OTC products and will also discuss trends in FDA audit for these products.
CD/Recorded
$229
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Recorded/CD
Best Practices for Writing an Effective SOP to Lead to Successful FDA Inspections

Best Practices for Writing an Effective SOP to Lead to Successful FDA Inspections

  • Speaker: Glen Feye
  • Product ID: 700375
  • Duration: 63 Mins
This SOP best practices webinar will show how to create “state of the art” SOP or review your current SOP so as to successfully manage FDA Investigators and other Regulatory Authorities Audits which can help improve and influence Audit Outcomes.
CD/Recorded
$149
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Recorded/CD
Managing Corporate Risks with ISO 31000

Managing Corporate Risks with ISO 31000

  • Speaker: Kelly Eisenhardt
  • Product ID: 705083
  • Duration: 60 Min
ISO 31000 is a standard developed by the International Organization for Standardization (ISO) which provides a basic guideline and principles for the application of risk management. Companies that use risk management processes vary across industries in scope and magnitude and address a wide variety of challenges. This training program will offer an in depth look into the key components of the ISO 31000 guideline and best practices to implement and support a corporate risk management strategy or program.
CD/Recorded
$0
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Recorded/CD
How to successfully audit software systems, and thereby avoid having FDA write software-related 483's and warning letters

How to successfully audit software systems, and thereby avoid having FDA write software-related 483's and warning letters

  • Speaker: Dennis Moore
  • Product ID: 700221
  • Duration: 60 Min
This Software Auditing Procedure training will discussion on FDA software Standard “General Principles of Software Validation”, Actual FDA investigator software auditing techniques for software failure investigations.
CD/Recorded
$299
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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
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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
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Recorded/CD
Deviation Investigation Best Practices: Ensuring Correct Content and Conclusions

Deviation Investigation Best Practices: Ensuring Correct Content and Conclusions

  • Speaker: Michael Ferrante
  • Product ID: 703538
  • Duration: 90 min
This webinar will help attendees understand the fundamental steps of a deviation investigation with focus on using facts and objective evidence to arrive at root cause and CAPA. Learn how to identify and avoid potential pitfalls during deviation investigations.
CD/Recorded
$249
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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
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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
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Recorded/CD
Latin America - Understanding Regulatory Compliance Requirements Across Life Science Industry Part II

Latin America - Understanding Regulatory Compliance Requirements Across Life Science Industry Part II

  • Speaker: Robert J Russell
  • Product ID: 701267
  • Duration: 90 Min
This Regulatory compliance training will cover topics relating to pre-clinical and clinical requirements, as well as, addressing the structure of the regulatory agencies in Latin America.
CD/Recorded
$0
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Recorded/CD
Risk Compliance Matrix for Internal Audit and SOX Operations - Active and Engaged Risk Management Activities

Risk Compliance Matrix for Internal Audit and SOX Operations - Active and Engaged Risk Management Activities

  • Speaker: Marna Steuart
  • Product ID: 704809
  • Duration: 75 Min
21st century business organizations require active and engaged risk management activities. Today's risk and compliance process is rather complex and dynamic, therefore it requires governance, risk and compliance professionals to possess certain skills in order to effectively complete their duties and responsibilities. The days of using staid audit programs are over. This training program will engage participants in evaluating each business process using a risk-based approach and in preparing risk and compliance documentation for each engagement.
CD/Recorded
$0
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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
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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
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Recorded/CD
Latin America - Understanding Regulatory Compliance Requirements Across Life Science Industry PART I

Latin America - Understanding Regulatory Compliance Requirements Across Life Science Industry PART I

  • Speaker: Robert J Russell
  • Product ID: 701260
  • Duration: 60 Min
The Latin America Regulatory compliance requirement training/webinar will cover topics relating to pre-clinical and clinical requirements, as well as, addressing the structure of the regulatory agencies in Latin America.
CD/Recorded
$0
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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
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Recorded/CD
Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences PART II

Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences PART II

  • Speaker: Robert J Russell
  • Product ID: 701266
  • Duration: 90 Min
This Japan Regulatory Filing training for life sciences is designed to provide an overview of the regulatory environment in Japan.
CD/Recorded
$0
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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
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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
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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
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Recorded/CD
Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences PART I

Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences PART I

  • Speaker: Robert J Russell
  • Product ID: 701258
  • Duration: 90 Min
This Regulatory compliance training is designed to provide an overview of the regulatory environment in Japan.
CD/Recorded
$299
View Details
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