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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
Veterinary Drug Approval Process and FDA's Regulatory Oversight

Veterinary Drug Approval Process and FDA's Regulatory Oversight

  • Speaker: Karl M. Nobert
  • Product ID: 703971
  • Duration: 60 Min
This training program will provide attendees with an introduction to FDA’s veterinary drug approval process. It will also discuss key components of an appropriate animal field study needed to support new animal drug approval and explain how jurisdiction is split between various federal agencies in certain cases.
CD/Recorded
$0
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Recorded/CD
Be Ready for eMDR Going Live August 14, 2015

Be Ready for eMDR Going Live August 14, 2015

  • Speaker: Rita Hoffman
  • Product ID: 703972
  • Duration: 110 Min
This training program will discuss the basics of the Medical Device Reporting (MDR) regulation and review the process for preparing and submitting Electronic Medical Device Reports (eMDRs).
CD/Recorded
$249
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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
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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
Onboarding in a GMP Environment: Best Practices for Foundational Employee Success

Onboarding in a GMP Environment: Best Practices for Foundational Employee Success

  • Speaker: Michael Esposito
  • Product ID: 705475
  • Duration: 75 Min
Onboarding new employees in a pharmaceutical company, which is required by law to follow the regulations governing current Good Manufacturing Practices (cGMP), creates additional complexities besides the Human Resources element. As government regulatory agencies have expectations regarding the process of qualifying employees to perform their job duties, it is essential to become familiar with these expectations and the implications that they have for the company’s training plan. In addition, companies have been penalized for failure to follow established regulations, which can create issues that can impede production, damage a company’s reputation, or ultimately lead to recalling or discontinuing product. Still, the process is not straightforward, and questions inevitably arise regarding the application of the regulations. This course will address the issues that accompany onboarding new or transferred employees and enable you to navigate them successfully.
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
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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