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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
How to Survive a DEA Inspection Series - For Manufacturers of Controlled Substances

How to Survive a DEA Inspection Series - For Manufacturers of Controlled Substances

  • Speaker: Carlos M Aquino
  • Product ID: 705164
  • Duration: 90 Min
This training covers DEA record-keeping and security topics that a DEA registrant must comply with when handling controlled substances. The focus is elements of what occurs during that unannounced inspection and the auditing methods.
CD/Recorded
$299
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Recorded/CD
Purchasing Cards: Overcoming Risks and Creating an Effective Program

Purchasing Cards: Overcoming Risks and Creating an Effective Program

  • Speaker: Brian G Rosenberg
  • Product ID: 704467
  • Duration: 60 Min
This training program will detail the components of a successful purchasing card program. It will also discuss implementing proper purchasing card controls, types of risk including fraud and misuse, auditing techniques, and more.
CD/Recorded
$249
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Recorded/CD
FDA’s Expectations from Supplier Management for GMP: Quality Agreements and More

FDA’s Expectations from Supplier Management for GMP: Quality Agreements and More

  • Speaker: Danielle DeLucy
  • Product ID: 704659
  • Duration: 60 Min
The FDA requires that manufacturers of pharmaceutical products have a documented process to assess its suppliers and contract manufacturers, that they have implemented that process, and that the process is effective. This training program will explore how having an effective supplier relationship management program will result in streamlining the supply chain, ensuring a more consistent level of quality components, materials and components, and be more cost effective to the manufacturer.
CD/Recorded
$299
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Recorded/CD
Zero-Injury Workplace Culture vs. Safety Culture

Zero-Injury Workplace Culture vs. Safety Culture

  • Speaker: Joe Keenan
  • Product ID: 704986
  • Duration: 60 Min
Creating a safety culture in the workplace takes time, patience, and is often a multi-year process. This training program will examine how organizations need to transition from the existing zero injury workplace culture to a more safety oriented culture. In the process, it will examine the pros and cons behind each process and also offer best practices to determine whether you are doing it right.
CD/Recorded
$199
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Recorded/CD
Basic and Meaningful Human Resource Metrics

Basic and Meaningful Human Resource Metrics

  • Speaker: Greg Chartier
  • Product ID: 701696
  • Duration: 70 Min
Learn different HR metrics which can be used across organization to improve performance of human resources
CD/Recorded
$229
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Recorded/CD
Health Canada Regulations on NHP's vs. FDA's Dietary Supplement Regulations

Health Canada Regulations on NHP's vs. FDA's Dietary Supplement Regulations

  • Speaker: Travis Austin MacKay
  • Product ID: 705497
  • Duration: 60 Min
This online training will offer an overview of what Health Canada considers to be a Natural Health product (NHP) and review Canadian regulatory requirements for Natural Health products. It will compare Canadian requirements with U.S. FDA requirements for marketing and labeling dietary supplements and convey an understanding of how they differ.
CD/Recorded
$209
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Recorded/CD
Root Cause Analysis - The Heart of Corrective Action

Root Cause Analysis - The Heart of Corrective Action

  • Speaker: Betty Lane
  • Product ID: 703391
  • Duration: 75 Min
This webinar will discuss how root cause is an essential part of a corrective action system and will provide some examples of how to perform root cause analysis.
CD/Recorded
$189
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Recorded/CD
Workplace Unconscious Bias: Minimizing the Impact on Discrimination, Hiring, Promotions, and Retention

Workplace Unconscious Bias: Minimizing the Impact on Discrimination, Hiring, Promotions, and Retention

  • Speaker: Dr. Susan Strauss
  • Product ID: 704876
  • Duration: 60 Min
Unconscious bias has been recognized as a form of discrimination and can therefore lead to lawsuits. This training program addresses the science of unconscious bias and lists the examples and types. The Instructor will discuss the implicit association test (IAT) and steps to minimize individual and organizational unconscious bias in hiring, promotions, and retention.
CD/Recorded
$249
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Recorded/CD
DEA, Your Registration and How to Lose It

DEA, Your Registration and How to Lose It

  • Speaker: Carlos M Aquino
  • Product ID: 701992
  • Duration: 120 Min
This 2-hr webinar on DEA Due Diligence will cover several recommendations to improve the Corporate Due Diligence when controlled substances and regulated chemicals are purchased by their customers and the steps that can be taken to detect and prevent the illicit use or diversion of any narcotic drug sold to customers.
CD/Recorded
$299
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Recorded/CD
Travel and Expense Policy Development and Automation

Travel and Expense Policy Development and Automation

  • Speaker: Brian G Rosenberg
  • Product ID: 704880
  • Duration: 60 Min
In this webinar training, you will learn how to create, maintain, and enforce a T&E policy for your organization. The Instructors will discuss the key components and best practices for policies.
CD/Recorded
$199
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Recorded/CD
Measurement Uncertainty in Microbiology

Measurement Uncertainty in Microbiology

  • Speaker: Michael Brodsky
  • Product ID: 703902
  • Duration: 60 Min
This training program will discuss the concept and application of uncertainty of measurement (MU) as required by ISO/IEC Standard 17025:2005 for laboratory accreditation, from a practical microbiological perspective, using unambiguous language and useful examples.
CD/Recorded
$179
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Recorded/CD
INCOTERMS - International Commercial Terms

INCOTERMS - International Commercial Terms

  • Speaker: John Dunlop
  • Product ID: 702213
  • Duration: 60 Min
This 60-minute webinar will help exporters understand International Commercial Terms, or INCOTERMs, published by the International Chamber of Commerce and how to select the correct one for their transactions.
CD/Recorded
$229
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Recorded/CD
Handling OOS Test Results and Completing Robust Investigations

Handling OOS Test Results and Completing Robust Investigations

  • Speaker: Danielle DeLucy
  • Product ID: 704351
  • Duration: 90 Min
This webinar will review the regulatory requirements for investigating an OOS Investigation. The responsibilities of the analyst, the supervisor and QA will be discussed. A detailed flow chart will be used to help the attendees clearly understand the steps and the order in which they are to be performed. The structure of an Investigation report which properly documents the investigation will be discussed.
CD/Recorded
$299
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Recorded/CD
Process Validation - Overview of Why and How

Process Validation - Overview of Why and How

  • Speaker: Betty Lane
  • Product ID: 703520
  • Duration: 60 Min
This webinar will provide understanding of FDA and ISO 13485 requirements for process validation and how to implement them.
CD/Recorded
$249
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Recorded/CD
Supplier Quality Agreements - Essential for Suppliers of Many Outsourced Processes

Supplier Quality Agreements - Essential for Suppliers of Many Outsourced Processes

  • Speaker: Betty Lane
  • Product ID: 702502
  • Duration: 75 Min
This webinar will provide you the information you need to create supplier quality agreements (QA Agreements) with key suppliers and to understand which of your suppliers should have these agreements to meet expectations of the FDA and ISO 13485 Notified Body auditors.
CD/Recorded
$249
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Recorded/CD
Design History Files and Technical Files/Design Dossiers - Meeting U.S. FDA CGMPS and the EU's MDD Requirements

Design History Files and Technical Files/Design Dossiers - Meeting U.S. FDA CGMPS and the EU's MDD Requirements

  • Speaker: John E Lincoln
  • Product ID: 701898
  • Duration: 90 Min
This 90-minute webinar will examine in detail the U.S. FDA and EU MDD requirements for DHFs, DMRs, DHRs, and TF/DDs - their formats, content, and their commonalities, differences, interrelationships, and similarities.
CD/Recorded
$199
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Recorded/CD
ISO 14971:2019 - Does your Risk Analysis meet this new revision of the Standard?

ISO 14971:2019 - Does your Risk Analysis meet this new revision of the Standard?

  • Speaker: Betty Lane
  • Product ID: 702871
  • Duration: 60 Min
This webinar will benefit medical device companies planning to have a CE mark under the European Union Directive 93/42/EEC. We will discuss what is new in ISO 14971:2019 and help you avoid delays in obtaining or maintaining your CE mark for compliance to the Medical device Directive, EU Directive 93/42/EEC on Medical Devices.
CD/Recorded
$199
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Recorded/CD
Management Controls Under QSR and ISO 13485

Management Controls Under QSR and ISO 13485

  • Speaker: Jeff Kasoff
  • Product ID: 700988
  • Duration: 60 Min
This session will discuss the requirements for Management Controls, including organizational structure, internal audits, establishment of a quality policy and confirmation it is being followed, establishment and contents of a quality system.
CD/Recorded
$0
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Recorded/CD
Quality Control of Microbiological Media, Reagents and Test Kits

Quality Control of Microbiological Media, Reagents and Test Kits

  • Speaker: Michael Brodsky
  • Product ID: 703599
  • Duration: 60 Min
The webinar will discuss QC best practices and procedures for verifying the suitability and performance characteristics of microbiological media and reagents.
CD/Recorded
$169
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Recorded/CD
QA Agreements for ISO 13485:2019 and other Regulatory Compliance

QA Agreements for ISO 13485:2019 and other Regulatory Compliance

  • Speaker: Betty Lane
  • Product ID: 703515
  • Duration: 60 Min
In this webinar you will learn how to create detailed quality agreements (QA Agreements) for key suppliers, particularly those for outsourced processes, and to understand which of your suppliers should have these agreements to meet the expectations of the FDA and ISO 13485:2016 and MDSAP. The agreements discussed will meet the expectations of the GHTF and NBOG supplier guidance documents which are now an expectation of both the FDA and most ISO 13485 auditors. These supplier QA agreements can be an important part of demonstrating that you have control of your key suppliers.
CD/Recorded
$189
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