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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
Utilizing ICH Guidelines for GCP Regulatory Compliance

Utilizing ICH Guidelines for GCP Regulatory Compliance

  • Speaker: Carl Anderson
  • Product ID: 700855
  • Duration: 60 Min
This presentation reviews key ICH guidelines to directly correlate them with FDA Compliance Program Guidance Manuals that FDA investigators use to conduct GCP inspections. This webinar will provide critical assistance to FDA regulated companies currently conducting or preparing to conduct clinical trials.
CD/Recorded
$299
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Recorded/CD
OSHA injury and illness recordkeeping

OSHA injury and illness recordkeeping

  • Speaker: William Principe
  • Product ID: 700854
  • Duration: 60 Min
This webinar will provide valuable assistance to all companies that are required to maintain an OSHA 300 Log. This seminar will teach you how to analyze cases to produce accurate OSHA 300 Logs.
CD/Recorded
$249
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Recorded/CD
Preparing Compliant eCTD Submissions

Preparing Compliant eCTD Submissions

  • Speaker: Antoinette Azevedo
  • Product ID: 700719
  • Duration: 60 Min
This webinar will provide valuable assistance to all companies regulated by FDA to understand the current and impending requirements for electronic submissions. The immediate impact is to companies submitting INDs and marketing applications for pharmaceutical and biological products.
CD/Recorded
$249
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Recorded/CD
Conducting and Documenting Proper Risk Analysis In compliance with ISO 14971

Conducting and Documenting Proper Risk Analysis In compliance with ISO 14971

  • Speaker: Edwin L Bills
  • Product ID: 700713
  • Duration: 60 Min
The presentation will review the complete requirements for Risk Analysis and give an example of how a company can easily create a Risk Analysis in full compliance with the standard. The information will assist in meeting various national and global regulatory requirements for medical devices.
CD/Recorded
$149
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Recorded/CD
Developing an Employee Handbook

Developing an Employee Handbook

  • Speaker: David J Zetter
  • Product ID: 700441
  • Duration: 60 Min
This HR Compliance training/webinar in developing hand book will helps in developing an effective employee handbook and what are the policies should you include in your hand book.
CD/Recorded
$149
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Recorded/CD
Overview of the Harmonized Tariff Schedule of the United States - Classifying Your Products for Customs Purposes

Overview of the Harmonized Tariff Schedule of the United States - Classifying Your Products for Customs Purposes

  • Speaker: Paula Connelly
  • Product ID: 700659
  • Duration: 60 Min
This Harmonized Tariff Schedule of the United States training/webinar will provide an overview of the structure of the HTSUS and how to use the HTSUS to determine the correct classification, duty rate, and possible quotas, restrictions or preferential duty rates that may be applicable to your product.
CD/Recorded
$149
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Recorded/CD
Part 11 - Electronic Records and Electronic Signatures

Part 11 - Electronic Records and Electronic Signatures

  • Speaker: Betty Jones
  • Product ID: 700619
  • Duration: 60 Min
This Part 11 - Electronic Records webinar will provide an insider’s view FDA’s current thinking regarding the scope and application of Part 11 of Title 21 of the Code of Federal Regulations; Electronic Records; Electronic Signatures (21 CFR Part 11).
CD/Recorded
$249
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Recorded/CD
OSHA 300 Recordkeeping: How To Do It Right!

OSHA 300 Recordkeeping: How To Do It Right!

  • Speaker: David Stumbo
  • Product ID: 700576
  • Duration: 60 Min
This OSHA webinar will review the requirements for OSHA 300 record keeping, including the basic tenants of coverage, recording criteria, forms, and postings.
CD/Recorded
$199
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Recorded/CD
Experiences of managing a quality management system for a virtual pharmaceutical company

Experiences of managing a quality management system for a virtual pharmaceutical company

  • Speaker: Simon Forster
  • Product ID: 700256
  • Duration: 60 Min
This quality management system webinar will discuss the advantages and disadvantages of the virtual models and useful to those companies which, while not adopting the full virtual model, contract out many or most of their development activities.
CD/Recorded
$249
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Recorded/CD
Designing Viral Clearance Studies for Biopharmaceuticals

Designing Viral Clearance Studies for Biopharmaceuticals

  • Speaker: Kathryn Martin Remington
  • Product ID: 700220
  • Duration: 60 Min
This Designing Viral Clearance training discuss the design and implementation of a viral clearance study that includes appropriate viruses to model existing and emergent viral threats and evaluates the impact of potential fluctuations in processing.
CD/Recorded
$249
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Recorded/CD
C-TPAT - Standard Operating Procedures for Security in the Supply Chain

C-TPAT - Standard Operating Procedures for Security in the Supply Chain

  • Speaker: Karma Ruiz,Charlie Hocker
  • Product ID: 700488
  • Duration: 60 Min
In this C-TPAT training we will walk you through the most effective processes we have developed and how they can be customized for your company.
CD/Recorded
$149
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Recorded/CD
Effective Employee Performance Documentation: Elements and Techniques

Effective Employee Performance Documentation: Elements and Techniques

  • Speaker: Marnie Green
  • Product ID: 700467
  • Duration: 60 Min
This Performance Documentation training will explore the elements of effective documentation and will offer practical useful tips for creating an environment where maintaining performance documentation is an easy part of the manager’s routine. Any employee status change that is based on performance (reassignment, demotion, termination) must be supported by adequate documentation.
CD/Recorded
$149
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Recorded/CD
C-TPAT - annual training for employees to fulfill C-TPAT requirements by CBP

C-TPAT - annual training for employees to fulfill C-TPAT requirements by CBP

  • Speaker: Karma Ruiz,Charlie Hocker
  • Product ID: 700487
  • Duration: 60 Min
This C-TPAT training will guide you on the annual training for employees to fulfill C-TPAT requirements by CBP.
CD/Recorded
$149
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Recorded/CD
Best Practices in 510(k) Submissions

Best Practices in 510(k) Submissions

  • Speaker: William G Mclain
  • Product ID: 700209
  • Duration: 60 Min
This presentation will review methods for finding predicates, using guidance documents and interacting with the agency. Participants will learn about the different types of 510(k) submissions and the benefits and drawback of using the 3rd party.
CD/Recorded
$249
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Recorded/CD
Technology Transfer of a Pharmaceutical Manufacturing Process

Technology Transfer of a Pharmaceutical Manufacturing Process

  • Speaker: Rodney E Thompson
  • Product ID: 700247
  • Duration: 60 Min
This webinar will cover the essential aspects for the cGMP-compliant technology transfer of a pharmaceutical manufacturing process.
CD/Recorded
$0
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Recorded/CD
Development Planning: How to Structure, Write, and Effective

Development Planning: How to Structure, Write, and Effective

  • Speaker: Richelle Helman
  • Product ID: 700190
  • Duration: 60 Min
This Training will identify and review the key planning documents, including team assignments, management and conduct of the project, project phases, and regulatory requirements and scheduling.
CD/Recorded
$249
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Recorded/CD
Making cGMP Documentation Practical

Making cGMP Documentation Practical

  • Speaker: Paula Shadle
  • Product ID: 700179
  • Duration: 60 Min
This cGMP Documentation training will provide value to regulated companies required to follow strict documentation standards, whether GLP, GCP, or GMP.
CD/Recorded
$249
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Recorded/CD
Validation of Analytical Methods and Procedures - Design, Conduct and Document for Efficiency and Compliance

Validation of Analytical Methods and Procedures - Design, Conduct and Document for Efficiency and Compliance

  • Speaker: Dr. Ludwig Huber
  • Product ID: 700158
  • Duration: 60 Min
This Validation training will guide attendees through the entire process from defining specifications, through developing and implementing validation experiments to FDA compliant documentation.
CD/Recorded
$249
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Recorded/CD
Change Control for Computer Systems - strategies and tools for FDA compliance

Change Control for Computer Systems - strategies and tools for FDA compliance

  • Speaker: Dr. Ludwig Huber
  • Product ID: 700078
  • Duration: 60 Min
This Computer system training will discuss strategies and provide tools for FDA compliance when managing change and version control of planned and unplanned changes.
CD/Recorded
$299
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Recorded/CD
Reducing the Cost of Creating Documents for FDA-Regulated Industries

Reducing the Cost of Creating Documents for FDA-Regulated Industries

  • Speaker: Chris Whalley
  • Product ID: 700126
  • Duration: 60 Min
This FDA compliance training will explain how to measure and reduce the FDA recordkeeping burden.
CD/Recorded
$299
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