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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
Design History Files and Technical Files under US FDA and EU MDD

Design History Files and Technical Files under US FDA and EU MDD

  • Speaker: John E Lincoln
  • Product ID: 701175
  • Duration: 60 Min
This medical device compliance training will be helped to see how to understand the similarities and differences of these two complimentary documents and how to comply with the respective requirements and develop compliant files to address. The U.S. FDA’s Design Control requirements of the QS Regulation mandate the initiation and maintenance of a product Design History File for products to be marketed in the U.S. The European Union’s Medical Device Directive and a company’s Notified Body require a Technical Dossier or Technical File to show compliance to the Essential Requirements of the MDD and associated relavant standards for product to be CE-marked and marked in those countries (and others). Attendees will be helped to see how to understand the similarities and differences of these two complimentarty documents. Attendees will be further helped to comply with the respective requirements and develop compliant files to address either or both.
CD/Recorded
$299
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Recorded/CD
How to conduct a Clinical Trial in accordance with FDA regulations and how to avoid the common deficiencies observed during FDA clinical audits

How to conduct a Clinical Trial in accordance with FDA regulations and how to avoid the common deficiencies observed during FDA clinical audits

  • Speaker: Elizabeth Bergan
  • Product ID: 701054
  • Duration: 90 Min
This Clinical Trial training will provide a detailed review of the FDA regulations for Clinical Trials Process. This presentation will provide a detailed review of the FDA regulations for Clinical Trials Process. After attending this session, participants will have an understanding of FDA regulations pertaining to the implementation of clinical trials and concepts of Good Clinical Practice (GCP) and Bioethics.
CD/Recorded
$199
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Recorded/CD
510(k) Applications made Simple

510(k) Applications made Simple

  • Speaker: E.J Smith
  • Product ID: 701082
  • Duration: 60 Min
This 510(k) Training covers the content requirements of a traditional 510(k) application and covers in detail the recommended 20 sections. This 510(k) Training deals only with those medical devices that require a 510(k) application. All Manufacturers introducing Class II medical devices to the US market must submit a FDA 510(k). It is also required for manufacturers that are changing the intended use of the medical device, or changing the technology of a cleared device such a way that it may significantly affect its safety or effectiveness.
CD/Recorded
$299
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Recorded/CD
The IDE (Investigational Device Exemption) - It's Purpose and Preparation

The IDE (Investigational Device Exemption) - It's Purpose and Preparation

  • Speaker: John E Lincoln
  • Product ID: 701087
  • Duration: 60 Min
This IDE (Investigational Device Exemption) webinar will cover its purpose and preparation recommended subject headings and content Submission and follow up Usage in the clinical trial(s).
CD/Recorded
$299
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Recorded/CD
Basics of Writing Validation Protocols for Medical Devices

Basics of Writing Validation Protocols for Medical Devices

  • Speaker: Lawrence Spritzer
  • Product ID: 701099
  • Duration:
This Medical Device training will describe the information needed to write such protocols, and the basic contents of those protocols. This webinar will provide valuable assistance to all regulated companies that need to validate their manufacturing processes.
CD/Recorded
$249
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Recorded/CD
Documenting & Conducting CAPA Investigations

Documenting & Conducting CAPA Investigations

  • Speaker: Nathan Conover
  • Product ID: 701038
  • Duration: 60 Min
This CAPA training provides a process to overcome challenges for Documentation and Conducting CAPA Investigations and integrates FDA requirements and guidelines. "Failure to employ effective CAPA systems can lead to FDA Warning Letters and worse. Accurate documentation is a must – but capturing information from a diverse workforce can be very difficult. Do you have what it takes to meet these challenges?".

Fact: The FDA has noted that 76% of all Warning Letters have CAPA-related issues. This is a significantly large percentage – the results of companies doing a bad job of identifying corrective and preventive actions as well as not validating plan effectiveness.

CD/Recorded
$249
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Recorded/CD
Deploying Regulatory-Compliant Clinical Research Data Management Systems

Deploying Regulatory-Compliant Clinical Research Data Management Systems

  • Speaker: Dale Hunscher
  • Product ID: 701068
  • Duration: 60 Min
This presentation covers the fundamental principles underlying the various compliance regulations and discusses their implications for system designers and integrators. Electronic data capture and management systems for clinical research must support many kinds of research, including clinical trials, prospective observational studies, and retrospective "chart mining". Regulatory requirements for new drug and device trials are the most stringent and complex, but even the smallest investigator-initiated study in an academic health center or community hospital or clinic must comply with human subject protection regulations and professional ethical guidelines, and meet information security requirements such as the HIPAA Privacy and Security Rules. This presentation covers the fundamental principles underlying the various compliance regulations and discusses their implications for system designers and integrators.
CD/Recorded
$249
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Recorded/CD
Effective Records, Document Control, and SOPs

Effective Records, Document Control, and SOPs

  • Speaker: Nick Campbell
  • Product ID: 701020
  • Duration: 60 Min
We will discuss methods and practices that will improve the clarity and control of your document control system. Effective GMP documentation practices will be reviewed to ensure your paperwork is clear, complete, and easy to understand.
CD/Recorded
$0
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Recorded/CD
GAMP® Validation Protocols for Efficient Documentation

GAMP® Validation Protocols for Efficient Documentation

  • Speaker: David Nettleton
  • Product ID: 701044
  • Duration: 60 Min
This session describes how to use the GAMP® standard to determine what has to be validated and explains how to create documentation that will meet regulatory requirements worldwide.
CD/Recorded
$0
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Recorded/CD
Using Electronic Health Records and Claims Databases for Rapid-Response Pharmacovigilance Studies

Using Electronic Health Records and Claims Databases for Rapid-Response Pharmacovigilance Studies

  • Speaker: Alan Hochberg
  • Product ID: 700972
  • Duration: 60 Min
This presentation will give an overview of these new tools and techniques for the non-statistician/epidemiologist. It is vital that a pharmaceutical manufacturer be able to quickly assess these issues on a sound statistical basis, in a way that eliminates bias due to confounding factors as much as possible.
CD/Recorded
$299
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Recorded/CD
Getting the Most Out Of Data Mining for Pharmacovigilance and Risk Management

Getting the Most Out Of Data Mining for Pharmacovigilance and Risk Management

  • Speaker: Alan Hochberg
  • Product ID: 700971
  • Duration: 60 Min
This presentation will give an overview of data mining systems, for the safety or regulatory professional who collaborates with data miners, and for the executive decision-maker who oversees the implementation of data mining.
CD/Recorded
$249
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Recorded/CD
Organization of Clinical Datasets in eCTD Submissions

Organization of Clinical Datasets in eCTD Submissions

  • Speaker: Antoinette Azevedo
  • Product ID: 700992
  • Duration: 90 Min
This presentation will review the documentation requirements, the electronic navigation aids required for all the components of the electronic datasets package for a clinical study. This webinar will provide valuable assistance to all pharmaceutical and biotechnology that are conducting clinical studies with the intent of filing Investigational New Drug (IND) and New Drug Applications (NDA) or Biological License Applications (BLA) submissions.
CD/Recorded
$249
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Recorded/CD
Premarket Approval (PMA) agreement with FDA for the medical device companies - the Requirements

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

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

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

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?

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

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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