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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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Excel Spreadsheets; Ensuring Data Integrity and 21 CFR Part 11 Compliance
1
/ Jul
Tuesday-2025

Excel Spreadsheets; Ensuring Data Integrity and 21 CFR Part 11 Compliance

  • Speaker: David Nettleton
  • Product ID: 701582
  • Duration: 75 min
Learn how to use Microsoft Excel spreadsheets for GXP data to ensure compliance with 21 CFR Part 11 and reduce validation cost and time.
* Per Attendee
$229
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Hypothesis Testing, P-values and Inference: When Thinking like a Statistician Makes Sense
10
/ Jul
Thursday-2025

Hypothesis Testing, P-values and Inference: When Thinking like a Statistician Makes Sense

  • Speaker: Elaine Eisenbeisz
  • Product ID: 703552
  • Duration: 120 Mins
This clinical research webinar will explore the reasoning that formulates null hypotheses and turns researchers’ hair gray. Attendees will learn the why and how of the scientific method and how to view the world with a statistician’s eyes. Also attendees will learn the possibilities and limitations of research questions and hypothesis development, how to interpret statistical findings with p-values, effect sizes, and confidence intervals.
* Per Attendee
$229
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Current Trends in FDA Inspections
17
/ Jul
Thursday-2025

Current Trends in FDA Inspections

  • Speaker: Michael Ferrante
  • Product ID: 703485
  • Duration: 90 Mins
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.
* Per Attendee
$199
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Recorded/CD
Effective Systems for Change Control in the Pharmaceutical Industry

Effective Systems for Change Control in the Pharmaceutical Industry

  • Speaker: David L Chesney
  • Product ID: 705002
  • Duration: 90 mins
This webinar will help you understand GMP requirements for change control from a pharmaceutical manufacturing perspective, the purpose of change control and what types of changes are or are not subject to change control. Participants will learn how to execute and implement a change in a regulated environment.
CD/Recorded
$249
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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
Storm Water Pollution Prevention Plans (SWPPP)

Storm Water Pollution Prevention Plans (SWPPP)

  • Speaker: Joe Keenan
  • Product ID: 705510
  • Duration: 90 Min
This webinar will discuss the basics of what is required in a Storm Water Pollution Prevention Plan (SWPPP), how to develop and implement and formalized SWPPP and address site-specific questions and scenarios.
CD/Recorded
$249
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Recorded/CD
Conducting Effective Quality Audits: Beyond Audit Checklists

Conducting Effective Quality Audits: Beyond Audit Checklists

  • Speaker: Michael Ferrante
  • Product ID: 703539
  • Duration: 60 Min
This webinar will teach attendees best practices for conducting effective quality audits to ensure regulatory compliance. Learn how to avoid potential pitfalls during the audit process.
CD/Recorded
$249
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Recorded/CD
Trial Master File and Clinical Data Management Regulated by FDA

Trial Master File and Clinical Data Management Regulated by FDA

  • Speaker: Carolyn Troiano
  • Product ID: 705360
  • Duration: 60 Min
This FDA compliance training will cover in detail the new requirements for trial master files including documents related to clinical trials that are required to be prepared, collected and maintained as part of the TMF.
CD/Recorded
$249
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Recorded/CD
CMO Supplier Quality Agreements - How to Comply with New FDA and EU Guidelines for Contract Drug Manufacturers

CMO Supplier Quality Agreements - How to Comply with New FDA and EU Guidelines for Contract Drug Manufacturers

  • Speaker: Roger Cowan
  • Product ID: 703476
  • Duration: 60 min
This webinar will include a detailed discussion of Contract Manufacturing Organizations (CMO) Quality Agreement topics such as change control, documentation, facilities and equipment, lab controls, sub-contracting, etc. Attendees will learn how to comply with new FDA and EU guidelines for contract drug manufacturers.
CD/Recorded
$249
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Recorded/CD
Supply Chain and Product Compliance Using RoHS, REACH, and Conflict Minerals

Supply Chain and Product Compliance Using RoHS, REACH, and Conflict Minerals

  • Speaker: Kelly Eisenhardt
  • Product ID: 703871
  • Duration: 60 Min
This training program will offer an in-depth look at three important product regulations focused on materials compliance and ethical sourcing, along with the tools and policies needed to implement them.
CD/Recorded
$249
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Recorded/CD
Good Documentation Practice and Record Keeping Regulations (FDA & EMA)

Good Documentation Practice and Record Keeping Regulations (FDA & EMA)

  • Speaker: Dr. Afsaneh Motamed Khorasani
  • Product ID: 705583
  • Duration: 60 Min
Good documentation Practices (GDP) is an essential factor that needs to be closely followed by the personnel in any regulated environment as a process for a successful project completion including observations of unanticipated responses that are required to be accurately recorded and verified. This 60-min Webinar covers the essentials of GDP, its definition, purpose, and importance. Then expands on general rules and principles of GDP (US & EU), General tips for Laboratory Notebook documentation and finally discussing GDP enforcement by regulatory bodies in different countries with some examples of FDA citations.
CD/Recorded
$249
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Recorded/CD
The Complexity and Interplay Among ADAAA, FMLA, and Worker's Comp (WC) - How Do They Work Together, or Not?

The Complexity and Interplay Among ADAAA, FMLA, and Worker's Comp (WC) - How Do They Work Together, or Not?

  • Speaker: Dr. Susan Strauss
  • Product ID: 704959
  • Duration: 90 Min
The webinar training will address ADAAA, FMLA, and Worker’s Comp laws that HR is responsible for upholding. When the laws are not followed, it increases the liability for the organization and interferes with a fair and equitable work environment for employees.
CD/Recorded
$249
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Recorded/CD
ACH Government Payment Processing - Handling Death Notification Entries (DNEs) and Reclamations

ACH Government Payment Processing - Handling Death Notification Entries (DNEs) and Reclamations

  • Speaker: Donna K Olheiser
  • Product ID: 704540
  • Duration: 90 Min

This 90-minute session will provide the details on what is different and how the Federal Government has adopted the NACHA Operating Rules and what the exceptions to those Rules incorporate for the Federal Government. You will learn what the Green Book is and how this valuable on-line tool will help you with processing DNE’s and Government Reclamations.
CD/Recorded
$249
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Recorded/CD
Family Care and Medical Leave in California - Part I

Family Care and Medical Leave in California - Part I

  • Speaker: Jacquiline M Wagner
  • Product ID: 704507
  • Duration: 90 Min
The Family and Medical Leave Act (29 U.S.C. § 2601 et seq)- known as the “FMLA”- was signed into law by President Bill Clinton in 1993 in response to a growing national concern about balancing work and family responsibilities.
CD/Recorded
$249
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Recorded/CD
1099 & W-9 Update - Complying with IRS Information Reporting Guidelines

1099 & W-9 Update - Complying with IRS Information Reporting Guidelines

  • Speaker: Miles Hutchinson
  • Product ID: 703220
  • Duration: 90 Min
For years the IRS has struggled with the independent contractor and tax collection. In assessing opportunities to close the tax gap (taxes due but not reported or paid), one of the greatest opportunities comes from expanding the information reporting on taxpayers by payors – the 1099. This time-consuming reporting obligation can be streamlined in a number of ways. Join us to learn more…
CD/Recorded
$249
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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
$149
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Recorded/CD
How to Prepare an Effective Audit Manual for an Internal Audit Department

How to Prepare an Effective Audit Manual for an Internal Audit Department

  • Speaker: Marna Steuart
  • Product ID: 703684
  • Duration: 75 Min
This webinar will instruct attendees on how to develop an internal audit manual and offer start to finish instructions and templates on how to perform different types of audits given the project description. Audit fieldwork, audit reporting and follow-up, work-paper filing, and project closure are some of the other areas the webinar will cover.
CD/Recorded
$199
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Recorded/CD
Writing an Effective SAR Narrative

Writing an Effective SAR Narrative

  • Speaker: Doug Keipper
  • Product ID: 702993
  • Duration: 60 Min
This BSA compliance training on Suspicious Activity Reporting (SAR) will provide details on how to prepare a SAR (Suspicious Activity Reporting) narrative that meets examiner scrutiny and provides necessary detail for law enforcement.
CD/Recorded
$199
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Recorded/CD
Business Writing for Financial Professionals

Business Writing for Financial Professionals

  • Speaker: Phil Vassallo
  • Product ID: 703262
  • Duration: 90 Min
This training on business writing will provide attendees tools and tips for effectively writing financial documents for diverse audiences. Learn best practices for getting an immediate response to any written document.
CD/Recorded
$249
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Recorded/CD
Stop Payments vs Unauthorized Entries – Compliance with the Nacha Operating Rules

Stop Payments vs Unauthorized Entries – Compliance with the Nacha Operating Rules

  • Speaker: Donna K Olheiser
  • Product ID: 704319
  • Duration: 90 Min
This training program will help find answers to many struggles with Stop Payments and Unauthorized Entries. These are still the number one issues in the exception processing of ACH transactions on a daily basis. This 90-minute session will definitely help clear things up on processing unauthorized, authorization revoked and stop payments!
CD/Recorded
$249
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