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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
Tips on Drafting Offer Letters, Employment Agreements, and Termination Letters

Tips on Drafting Offer Letters, Employment Agreements, and Termination Letters

  • Speaker: Stephanie Yang
  • Product ID: 703447
  • Duration: 75 Min
This webinar will explain the basic components of a good offer letter, employment agreement, or termination letter. It will provide attendees HR best practices for drafting these documents to avoid common mistakes and pitfalls.
CD/Recorded
$149
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Recorded/CD
Dual and Third-Country Nationals: Ensuring Foreign Licensee Requirements to Prevent Diversion of ITAR-Controlled Defense Articles

Dual and Third-Country Nationals: Ensuring Foreign Licensee Requirements to Prevent Diversion of ITAR-Controlled Defense Articles

  • Speaker: Darrell Coleman
  • Product ID: 703454
  • Duration: 70 Min
This webinar will explain the requirements of ITAR 126.18 regarding the transfer of defense articles (including technical data) to dual and third-country nationals employed by approved foreign end-users. Attendees will learn how to ensure compliance with the ITAR and avoid violations and penalties.
CD/Recorded
$149
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Recorded/CD
Site Preparation Strategy and Successful FDA Inspection

Site Preparation Strategy and Successful FDA Inspection

  • Speaker: Yasamin Ameri
  • Product ID: 703441
  • Duration: 60 Min
This webinar will explain the Good Manufacturing Practices (GMP) requirements. Attendees will learn strategies for site preparation and hosting of an inspection.
CD/Recorded
$229
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Recorded/CD
Selecting the Most Appropriate Predicate Device(S) for your 510(k) Application

Selecting the Most Appropriate Predicate Device(S) for your 510(k) Application

  • Speaker: Cheryl Wagoner
  • Product ID: 703438
  • Duration: 60 Min
This webinar will provide tips and techniques on how to research and identify appropriate predicate devices for a 510(k) application.
CD/Recorded
$229
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Recorded/CD
Data Management SOPs

Data Management SOPs

  • Speaker: Adam Ruskin
  • Product ID: 703376
  • Duration: 60 Min
This webinar will teach attendees how to develop more efficient data management SOPs for their company, whether they perform these tasks in-house, oversee this task that a vendor provides, or outsource this task in its entirety.
CD/Recorded
$50
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Recorded/CD
Issues - Terminations and Exits - Legal Compliance

Issues - Terminations and Exits - Legal Compliance

  • Speaker: Diana Chomichuk
  • Product ID: 703428
  • Duration: 60 Min
This webinar will explain how to manage employee terminations and exits. Attendees will gain understanding and discover recommended best practices and techniques for ensuring compliance, fairness, and reasonable support during sensitive employee terminations and exits.
CD/Recorded
$149
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Recorded/CD
Regulatory Records Primer: Decoding the Requirements for Medical Device and Pharmaceutical Manufacturers

Regulatory Records Primer: Decoding the Requirements for Medical Device and Pharmaceutical Manufacturers

  • Speaker: Les Schnoll
  • Product ID: 703433
  • Duration: 90 Min
This webinar will explain FDA regulatory records requirements for medical devices and finished pharmaceuticals. It will cover statutory requirement, required content, format, purpose, retention, and structure for regulatory records for both medical devices and pharmaceuticals.
CD/Recorded
$50
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Recorded/CD
Quality Systems Approach for Validation and Maintenance of a Global ERP System

Quality Systems Approach for Validation and Maintenance of a Global ERP System

  • Speaker: James Carron
  • Product ID: 703424
  • Duration: 90 Min
This webinar will explain how to implement an Enterprise Resource Planning (ERP) system by integrating a company’s existing quality system. It will cover selection, analysis, initiation, design, validation and test phases, including change control.
CD/Recorded
$50
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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
The New European Union Clinical Trials Regulation: An Analysis of the Key Changes and their Implications for Future Clinical Trials

The New European Union Clinical Trials Regulation: An Analysis of the Key Changes and their Implications for Future Clinical Trials

  • Speaker: Ciara Farrell,Elisabethann Wright
  • Product ID: 703445
  • Duration: 60 Min
This webinar will review the changes introduced by the new European Union ("EU") Clinical Trials Regulation and the implications for future clinical trials.
CD/Recorded
$229
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Recorded/CD
LDT including CDx; CLIA versus FDA's Authority

LDT including CDx; CLIA versus FDA's Authority

  • Speaker: Abdel Halim
  • Product ID: 703399
  • Duration: 60 Min
This webinar will explain the regulatory path of an in vitro diagnostic (IVD) and Laboratory Developed Test (LDT). It will discuss the CLIA regulations for Laboratory Developed Tests (LDTs), including companion diagnostics (CDx) and how these differ from the FDA’s authority.
CD/Recorded
$229
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Recorded/CD
How to respond to GXP (GCP, GLP, GMP, GPV) Inspection and Audit Findings using Correction and Preventative Action (CAPA)

How to respond to GXP (GCP, GLP, GMP, GPV) Inspection and Audit Findings using Correction and Preventative Action (CAPA)

  • Speaker: Laura Brown
  • Product ID: 703160
  • Duration: 60 Min
This webinar will help attendees understand how to respond to inspection and audit findings using CAPA (Correction and Preventative Action) for all types of GXP inspections and audit (eg GCP, GLP, GMP, GPV).
CD/Recorded
$229
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Recorded/CD
Business Associate Agreements (BAA): Why the Pushback from Business Associates

Business Associate Agreements (BAA): Why the Pushback from Business Associates

  • Speaker: Tom Dumez
  • Product ID: 703397
  • Duration: 60 Min
This webinar will explain the requirements of the Omnibus Final Rule regarding Business Associate Agreements (BAA’s) including what it was, what it is now, and what it might be in the future. It will discuss responsibility, liability, indemnification, injunctive relief, and other topics that are causing, or may be causing, contention.
CD/Recorded
$229
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Recorded/CD
Understanding OSHA - Avoiding Citations and Preparing for the Unexpected

Understanding OSHA - Avoiding Citations and Preparing for the Unexpected

  • Speaker: Paul Gogulski PE
  • Product ID: 703419
  • Duration: 90 Min
This webinar will explain how to prepare for an unannounced OSHA inspection and avoid citations and fines. Attendees will learn how to effectively use Job Hazard Analysis (JHA) to prevent accidents in the workplace.
CD/Recorded
$50
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Recorded/CD
Overview of Importing Foreign Cosmetic and OTC Products

Overview of Importing Foreign Cosmetic and OTC Products

  • Speaker: Marc Sanchez
  • Product ID: 703379
  • Duration: 60 Min
This webinar will cover key definitions like cosmetics, new drugs, adulteration and misbranding, including key concepts like color additive restrictions and labeling requirements. Attendees will learn best practices for responding to Warning Letters.
CD/Recorded
$229
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Recorded/CD
Document Approval, Control, and Distribution: How to Meet FDA QSR and ISO 13485 Requirements

Document Approval, Control, and Distribution: How to Meet FDA QSR and ISO 13485 Requirements

  • Speaker: Jeff Kasoff
  • Product ID: 700254
  • Duration: 60 Min
This presentation will review the QSR and ISO requirements for document control, and provide a streamlined process for document control.
CD/Recorded
$229
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Recorded/CD
How to Conduct an FLSA Classification Self-Audit

How to Conduct an FLSA Classification Self-Audit

  • Speaker: Max Muller
  • Product ID: 703388
  • Duration: 60 Min
This webinar will explain how to undertake a voluntary self-audit of your organization’s pay practices. Attendees will learn how to determine who is exempt from the overtime provisions of the FLSA and how to document classification decisions.
CD/Recorded
$149
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Recorded/CD
Successful Steps in Documenting Unsatisfactory Employee Performance

Successful Steps in Documenting Unsatisfactory Employee Performance

  • Speaker: Glenn Harris
  • Product ID: 703385
  • Duration: 75 Min
This webinar will explain key steps in documenting employee unsatisfactory performance and progressive employee discipline. Attendees will learn how to clearly and effectively communicate to employees desired behavior and provide specific directives for employee improvement.
CD/Recorded
$50
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Recorded/CD
How to Prepare and Implement a Fraud Response Plan

How to Prepare and Implement a Fraud Response Plan

  • Speaker: Peter Goldmann
  • Product ID: 703284
  • Duration: 90 Min
This fraud investigation training will teach attendees best practices for preparing and implementing fraud response plan. Learn how to conduct E-Discovery and forensic data analytics.
CD/Recorded
$149
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Recorded/CD
FDA Regulatory Actions: It's Not Just about Warning Letters

FDA Regulatory Actions: It's Not Just about Warning Letters

  • Speaker: Fredric Richman
  • Product ID: 703344
  • Duration: 60 Min
This training will outline the possible consequences for failing to promptly and adequately correct significant violations related to cGMPs, new drugs or devices, labeling or other regulatory issues resulting in advisory, administrative and judicial actions.
CD/Recorded
$229
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