Regulatory Affairs

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Three Phases of QSR-Compliant Equipment Control

$177.00
The next time you walk the manufacturing floor, think about how many pieces of equipment you use for production, how many moving parts they have, and all the ways things could go terribly wrong. View

The 21st Century Cures Act’s Impact on Medical Devices - Webinar CD/Transcript

$287.00
The passage of the 21st Century Cures Act means you will be scrambling to meet new mandates… regulations and guidances in several key areas — including data development and maintenance, technical support, clinical approvals, breakthrough devices, device inspections and reviews, and humanitarian device exemptions. View

Medical Device Supplier Quality Management - Webinar CD/Transcript

$187.00
Purchasing controls and supplier management continue to be target-rich environments for FDA investigators. Join expert Jim Shore — Director of Quality at Titan Medical, Inc. — for an overview and up-to-date information on purchasing controls for quality assurance and control of purchased components, services or finished medical devices. View

China Medical Device Regulatory Changes - Webinar CD/Transcript

$187.00
If you’re doing business in China or want to — you need to know the latest device regulatory requirements for manufacturing devices there. This session will cover developments in manufacturing regulations including new GMPs, self-inspections, foreign inspections and trends in enforcement. View

The Correction and Removals Guidance - Webinar CD/Transcript

$287.00
It’s been two years since the guidance was published and device manufacturers are still confused about what to do when it comes to corrections and removals. How can you tell the differences between a device enhancement — which is not reported to the FDA — a reportable activity and reporting exceptions? View

Inspection Intelligence: Develop a Data–Driven Approach - Webinar CD/Transcript

$287.00
To be inspection ready you must understand both the internal and external data affecting your products — and analyze and act on the data. Expert Armin Torres — Principal Software Consultant at Qualified Data Systems — discusses how to make sure that your data — which has come from multiple sources — is internally consistent across the full data set and with your company metrics and KPIs. View

Clinical Investigator Questions, FDA Answers

$397.00
FDAnews’ staff has culled through questions submitted to OGCP about investigations and curated more than 90 of the most relevant responses for you — segmented by category — saving you the time and frustration of sifting through the questions and responses. View

Implementing an 11-Step Plan for Device Software Validation and Verification, 2016 Edition

$397.00
This updated edition of Implementing an 11-Step Plan for Device Software Validation and Verification contains a new chapter outlining the software validation requirements in ISO 13485:2016. View

Validating the Software That Powers Your Manufacturing Systems and Automated Processes - Webinar CD/Transcript

$287.00
What does software validation require? Clear thinking… good plans… solid execution… complete records. Industry expert, Dan O’Leary discusses the FDA’s QSR requirements for validation of software used in both production and the quality management system. View

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. View

Top Ten Data Integrity Traps: How to Find and Fix Problems

$177.00
The Top Ten Data Integrity Traps report shows you where most data integrity problems occur and helps you create a plan to weed them out — and keep them out. View

Effective and Efficient Medical Device Recalls - Webinar CD/Transcript

$287.00
You can’t afford to make mistakes during a recall. Join Willie Bryant and Chris Harvey — both of Stericycle ExpertSOLUTIONS for a discussion on how to assess your current recall plans to see if they’ll really work when you put them into action. View