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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.

Recorded/CD

Premarket Approval (PMA) agreement with FDA for the medical device companies - the Requirements

Speaker: E.J Smith
Product ID: 700955
Duration: 60 Min

This class reviews the modular option of filing a PMA and the benefits it offers all companies having to negotiate through the PMA process.

CD/Recorded
$249

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Recorded/CD

How to Prepare and Submit a Bullet Proof 510(k) Submission

Speaker: David Dills
Product ID: 700981
Duration: 60 Min

This webinar will provide valuable assistance and guidance to all medical device companies that are preparing and submitting 510(k)s to FDA for review and approval.

CD/Recorded
$249

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Recorded/CD

Data and Safety Monitoring in Clinical Research Involving Human Subjects - When and How

Speaker: Charles H Pierce
Product ID: 700924
Duration: 90 Min

This webinar will provide invaluable assistance to investigators and their staff in the regulatory / legal responsibilities and also the ethical considerations in pharmaceutical product (Drug or device) research involving human subjects. All Clinical Research protocols have a prominent safety monitoring plan as part of the overall research plan / protocol. This "plan" is to ensure the safety of participating subjects and to ensure the validity and integrity of the data.

CD/Recorded
$299

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Recorded/CD

Develop, Execute and Enforce an Effective Validation Master Plan

Speaker: David Dills
Product ID: 700910
Duration: 60 Min

Understand why the VMP is a project management tool and why it’s a living, breathing document. This webinar will provide valuable assistance and guidance to all life sciences manufacturers that are preparing to use or are currently using validation master plans to bullet-proof their validation programs.

CD/Recorded
$249

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Recorded/CD

Human Factors Standards and Guidance's for Medical Devices - which documents apply to my situation?

Speaker: Robert A North
Product ID: 700861
Duration: 60 Min

This webinar will apply to manufacturers with devices that require user-device interactions to set-up, operate, and maintain the device.

CD/Recorded
$299

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Recorded/CD

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

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

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

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

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

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

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!

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

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

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

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

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

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

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