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The Special Protocol Assessment: Winning FDA Support for Trial Design management report digs into the draft guidance to find vital information.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

False Claims Act Liability: A Guide for Drug and Device Manufacturers

$397.00
The False Claims Act Liability management report explains the basics of FCA liability and highlights areas of regulatory risk for drug and device manufacturers. Use it to build a strategy for avoiding problems and dealing with charges if they do happen. Read More

Products in Drug Products

International Standards for Clinical Trials

International Standards for Clinical Trials: Manual of ICH Efficacy Guidelines

$249.00
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Kellie Combs and Sarah Blankstein-blue

Pharmaceutical Expedited Pathways – Webinar Recording/Transcript

$287.00
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Manufacturing Quality: Using Audit Observations to Predict Problems – Webinar Recording/Transcript

$387.00
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Products in Drug Books

International Standards for Clinical Trials

International Standards for Clinical Trials: Manual of ICH Efficacy Guidelines

$249.00
Learn More
Orphan Drug Designation

Orphan Drug Designation: Benefits and Challenges

$397.00
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Clinical Data Integrity

Clinical Data Integrity: FDA and DOJ Enforcement Priorities

$397.00
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Products in Device Products

International Standards for Clinical Trials

International Standards for Clinical Trials: Manual of ICH Efficacy Guidelines

$249.00
Learn More
Schniepp-Steven-Seyed-Michael-Matthew-green.jpg

Manufacturing Quality: Using Audit Observations to Predict Problems – Webinar Recording/Transcript

$387.00
Learn More
Shelly Garg - Aqua 500

FDA Pathways to Bring your Medical Device to Market: What Regulatory Professionals Need to Know – Webinar Recording/Transcript

$287.00
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Products in Device Books

International Standards for Clinical Trials

International Standards for Clinical Trials: Manual of ICH Efficacy Guidelines

$249.00
Learn More
Clinical Data Integrity

Clinical Data Integrity: FDA and DOJ Enforcement Priorities

$397.00
Learn More
Complying with the EU MDR

Complying with the EU MDR: New Guidances, Standards and Procedures

$397.00
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Products in Clinical Products

International Standards for Clinical Trials

International Standards for Clinical Trials: Manual of ICH Efficacy Guidelines

$249.00
Learn More
Clinical Data Integrity

Clinical Data Integrity: FDA and DOJ Enforcement Priorities

$397.00
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Dennett Kouri and Faviola Michelot - 500blue

Building a World-Class Regulatory Intelligence and Support System – Webinar Recording/Transcript

$287.00
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Products in Books

International Standards for Clinical Trials

International Standards for Clinical Trials: Manual of ICH Efficacy Guidelines

$249.00
Learn More
Orphan Drug Designation

Orphan Drug Designation: Benefits and Challenges

$397.00
Learn More
Clinical Data Integrity

Clinical Data Integrity: FDA and DOJ Enforcement Priorities

$397.00
Learn More
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Products in Webinar Recordings

Kellie Combs and Sarah Blankstein-blue

Pharmaceutical Expedited Pathways – Webinar Recording/Transcript

$287.00
Learn More
Schniepp-Steven-Seyed-Michael-Matthew-green.jpg

Manufacturing Quality: Using Audit Observations to Predict Problems – Webinar Recording/Transcript

$387.00
Learn More
Shelly Garg - Aqua 500

FDA Pathways to Bring your Medical Device to Market: What Regulatory Professionals Need to Know – Webinar Recording/Transcript

$287.00
Learn More
More in Webinar Recordings
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