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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.
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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](/images/products/medium/701175.jpg)
Design History Files and Technical Files under US FDA and EU MDD
- Speaker: John E Lincoln
- Product ID: 701175
- Duration: 60 Min
CD/Recorded
$299
$299
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](/images/products/medium/701054.jpg)
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
CD/Recorded
$199
$199
Recorded/CD
![510(k) Applications made Simple 510(k) Applications made Simple](/images/products/medium/701082.jpg)
510(k) Applications made Simple
- Speaker: E.J Smith
- Product ID: 701082
- Duration: 60 Min
CD/Recorded
$299
$299
Recorded/CD
![The IDE (Investigational Device Exemption) - It's Purpose and Preparation The IDE (Investigational Device Exemption) - It's Purpose and Preparation](/images/products/medium/701087.jpg)
The IDE (Investigational Device Exemption) - It's Purpose and Preparation
- Speaker: John E Lincoln
- Product ID: 701087
- Duration: 60 Min
CD/Recorded
$299
$299
Recorded/CD
![Basics of Writing Validation Protocols for Medical Devices Basics of Writing Validation Protocols for Medical Devices](/images/products/medium/701099.jpg)
Basics of Writing Validation Protocols for Medical Devices
- Speaker: Lawrence Spritzer
- Product ID: 701099
- Duration:
CD/Recorded
$249
$249
Recorded/CD
![Documenting & Conducting CAPA Investigations Documenting & Conducting CAPA Investigations](/images/products/medium/701038.jpg)
Documenting & Conducting CAPA Investigations
- Speaker: Nathan Conover
- Product ID: 701038
- Duration: 60 Min
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
$249
Recorded/CD
![Deploying Regulatory-Compliant Clinical Research Data Management Systems Deploying Regulatory-Compliant Clinical Research Data Management Systems](/images/products/medium/701068.jpg)
Deploying Regulatory-Compliant Clinical Research Data Management Systems
- Speaker: Dale Hunscher
- Product ID: 701068
- Duration: 60 Min
CD/Recorded
$249
$249
Recorded/CD
![Effective Records, Document Control, and SOPs Effective Records, Document Control, and SOPs](/images/products/medium/701020.jpg)
Effective Records, Document Control, and SOPs
- Speaker: Nick Campbell
- Product ID: 701020
- Duration: 60 Min
CD/Recorded
$0
$0
Recorded/CD
GAMP® Validation Protocols for Efficient Documentation
- Speaker: David Nettleton
- Product ID: 701044
- Duration: 60 Min
CD/Recorded
$0
$0
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](/images/products/medium/700972.jpg)
Using Electronic Health Records and Claims Databases for Rapid-Response Pharmacovigilance Studies
- Speaker: Alan Hochberg
- Product ID: 700972
- Duration: 60 Min
CD/Recorded
$299
$299
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](/images/products/medium/700971.jpg)
Getting the Most Out Of Data Mining for Pharmacovigilance and Risk Management
- Speaker: Alan Hochberg
- Product ID: 700971
- Duration: 60 Min
CD/Recorded
$249
$249
Recorded/CD
![Organization of Clinical Datasets in eCTD Submissions Organization of Clinical Datasets in eCTD Submissions](/images/products/medium/700992.jpg)
Organization of Clinical Datasets in eCTD Submissions
- Speaker: Antoinette Azevedo
- Product ID: 700992
- Duration: 90 Min
CD/Recorded
$249
$249
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](/images/products/medium/700955.jpg)
Premarket Approval (PMA) agreement with FDA for the medical device companies - the Requirements
- Speaker: E.J Smith
- Product ID: 700955
- Duration: 60 Min
CD/Recorded
$249
$249
Recorded/CD
![How to Prepare and Submit a Bullet Proof 510(k) Submission How to Prepare and Submit a Bullet Proof 510(k) Submission](/images/products/medium/700981.gif)
How to Prepare and Submit a Bullet Proof 510(k) Submission
- Speaker: David Dills
- Product ID: 700981
- Duration: 60 Min
CD/Recorded
$249
$249
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](/images/products/medium/700924.jpg)
Data and Safety Monitoring in Clinical Research Involving Human Subjects - When and How
- Speaker: Charles H Pierce
- Product ID: 700924
- Duration: 90 Min
CD/Recorded
$299
$299
Recorded/CD
![Develop, Execute and Enforce an Effective Validation Master Plan Develop, Execute and Enforce an Effective Validation Master Plan](/images/products/medium/700910.gif)
Develop, Execute and Enforce an Effective Validation Master Plan
- Speaker: David Dills
- Product ID: 700910
- Duration: 60 Min
CD/Recorded
$249
$249
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?](/images/products/medium/700861.jpg)
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
CD/Recorded
$299
$299
Recorded/CD
Utilizing ICH Guidelines for GCP Regulatory Compliance
- Speaker: Carl Anderson
- Product ID: 700855
- Duration: 60 Min
CD/Recorded
$299
$299
Recorded/CD
OSHA injury and illness recordkeeping
- Speaker: William Principe
- Product ID: 700854
- Duration: 60 Min
CD/Recorded
$249
$249
Recorded/CD
![Preparing Compliant eCTD Submissions Preparing Compliant eCTD Submissions](/images/products/medium/700719.jpg)
Preparing Compliant eCTD Submissions
- Speaker: Antoinette Azevedo
- Product ID: 700719
- Duration: 60 Min
CD/Recorded
$249
$249
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