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CRF 9 2019

Nine-Volume Title 21 CFR Set 2019

$585.00
The federal government has compiled the new 2019 CFR volumes.






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FDA and ISO Devicemaker Training Requirements

FDA and ISO Devicemaker Training Requirements

$397.00
FDA and ISO Devicemaker Training Requirements breaks down training requirements in both the FDA’s QSR and international standards ISO 13485, 9001 and 10018 — among others — shows where they overlap and where they differ and provides a plan for developing a training program that fills in all the gaps. Read More
UDI Direct Marking for FDA Compliance: Navigating New Rules

UDI Direct Marking for FDA Compliance: Navigating New Rules

$197.00
Jay Crowley was the architect of UDI while at the FDA. Now a consultant advising devicemakers, he remains the go-to expert on UDI compliance. In the FDAnewsBrief, UDI Direct Marking for FDA Compliance, Crowley lays out a path to compliance. Read More
Supplier Quality Metrics for Devicemakers: Predicting and Selecting the Best

Supplier Quality Metrics for Devicemakers: Predicting and Selecting the Best

$397.00
In the Supplier Quality Metrics for Devicemakers management report you’ll learn how to use predictive analysis of such metrics as delivery time, management efficiency and lot acceptance rate to identify suppliers you can count on and spot potential problems in the future. Read More

Special Protocol Assessment: Winning FDA Support for Trial Design

$397.00
The Special Protocol Assessment: Winning FDA Support for Trial Design management report digs into the draft guidance to find vital information. Read More

QSR-Compliant Purchasing Controls: A Five-Stage Plan

$177.00
Follow the five-step plan in QSR-Compliant Purchasing Controls to avoid becoming part of that statistic. This FDAnewsBrief explains what the regulation requires and how to make sure your system passes muster. Read More

Products in Drug Products

Risks of Social Media Communication

Risks of Social Media Communication: A Guide to FDA and FTC Enforcement

$397.00
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Richard-Kingston-and-Diane-McEnroe-600red

Recall Readiness: Dust Off Your SOPs, There’s a New Guidance in Town – Webinar Recording/Transcript

$287.00
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FDA’s Alternative Inspection Tools

FDA’s Alternative Inspection Tools: Expert Answers to Drug and Biologics Manufacturers’ Questions

$397.00
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Products in Drug Books

Risks of Social Media Communication

Risks of Social Media Communication: A Guide to FDA and FTC Enforcement

$397.00
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FDA’s Alternative Inspection Tools

FDA’s Alternative Inspection Tools: Expert Answers to Drug and Biologics Manufacturers’ Questions

$397.00
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Supply Chain Solutions: Managing Demand and Logistics in a Postpandemic World

Supply-Chain Solutions: Managing Demand and Logistics in a Postpandemic World

$397.00
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Products in Device Products

Risks of Social Media Communication

Risks of Social Media Communication: A Guide to FDA and FTC Enforcement

$397.00
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Richard-Kingston-and-Diane-McEnroe-600red

Recall Readiness: Dust Off Your SOPs, There’s a New Guidance in Town – Webinar Recording/Transcript

$287.00
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Jessica Ringel -green600

Meet CDRH’s New Strategic Priorities: Where the Center is Headed and How Devicemakers Can Keep Up – Webinar Recording/Transcript

$287.00
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Products in Device Books

Risks of Social Media Communication

Risks of Social Media Communication: A Guide to FDA and FTC Enforcement

$397.00
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Selecting and Implementing Electronic Document Management Systems in the EU

Selecting and Implementing Electronic Document Management Systems in the EU

$197.00
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FDA’s New Quality System Regulation: Transitioning from QSR to ISO 13485

FDA’s New Quality System Regulation: Transitioning from QSR to ISO 13485

$197.00
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New Inspection Models

New Inspection Models: Will Your Next Regulatory Audit Be On-Site, Virtual or Hybrid?

$397.00
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David Harrison -blue500

Spreadsheet Validation: Best Practices to Maintain Compliance – Webinar Recording/Transcript

$287.00
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The Biden Administration’s FDA

The Biden Administration’s FDA: The First Six Months and What to Expect for the Rest of the Year – Webinar Recording/Transcript

$337.00
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Risks of Social Media Communication

Risks of Social Media Communication: A Guide to FDA and FTC Enforcement

$397.00
Learn More
FDA’s Alternative Inspection Tools

FDA’s Alternative Inspection Tools: Expert Answers to Drug and Biologics Manufacturers’ Questions

$397.00
Learn More
Supply Chain Solutions: Managing Demand and Logistics in a Postpandemic World

Supply-Chain Solutions: Managing Demand and Logistics in a Postpandemic World

$397.00
Learn More
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Products in Webinar Recordings

Richard-Kingston-and-Diane-McEnroe-600red

Recall Readiness: Dust Off Your SOPs, There’s a New Guidance in Town – Webinar Recording/Transcript

$287.00
Learn More
Jessica Ringel -green600

Meet CDRH’s New Strategic Priorities: Where the Center is Headed and How Devicemakers Can Keep Up – Webinar Recording/Transcript

$287.00
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Pamela Forrest  -Aqua 500

Medical Device Reporting: Best Practices and Common Pitfalls – Webinar Recording/Transcript

$287.00
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