Quality

ARTICLES

Epimed Lands Form 483 for Inadequate Procedures

Epimed International Inc. was cited in a Form 483 for inadequate procedures for handling of complaints, design validation, design transfer, control over products, services and suppliers, and accepting incoming products at its Johnstown, N.Y. facility. Read More

New ISO Standard Updates Luer Connector Design

The International Organization for Standardization has released a standard that specifies design and performance requirements of small-bore Luer connectors used in intravascular applications or hypodermic connections in medical devices and accessories. Read More

PRODUCTS

Complaint Management for Devicemakers: From Receiving and Investigating to Analyzing Trends

$397.00
Complaint management is essential to a functioning quality management system. Understanding the FDA’s Quality System Regulation isn’t enough — you must also master ISO 13485:2016 and the new EU MDR. They all require devicemakers to conduct trending in some form or another. But none of them tell you HOW. View

Choosing the Best Device Sample Size for Verification and Validation - Webinar CD/Transcript

$287.00
When performing process validations the question frequently asked is “How many do I need?” The answer is — it depends. There are several factors that must be considered when determining the appropriate sample size, including risks assessment, production costs, inspection costs, measuring, and testing. View

Spreadsheet Validation 2017 - Webinar CD/Transcript

$287.00
What if you could perch on the shoulder of an expert on spreadsheet validation ... look on in real time as he highlights potential pitfalls and defines innovative validation approaches ... ask why he does this instead of that ... and get feedback? View

Good Clinical Practices: The New ICH E6 Standard

$397.00
Good Clinical Practices: The New ICH E6 Standard outlines the changes in the guideline and offers suggestions for implementing new requirements. View

Biological Risk Evaluation and Management for Medical Devices

$397.00
Biological Risk Evaluation and Management for Medical Devices shows how the FDA incorporates the two ISO standards in its medical device development policy, how the EU version of the two standards differs in significant ways and how the EU Medical Device Regulation may require further changes in the European standards. View

Disinfectant Testing and Validation - Webinar CD/Transcript

$287.00
Keeping cleanrooms clean takes more than soap and water. A lot more. It’s a complicated — but critical — topic for drug, device, biologics and supplement makers, and compounders too. View

Hack-Proofing Medical Devices: Ensuring Product Safety through Cybersecurity

$397.00
Hack-Proofing Medical Devices will show you how to get — and keep — control of your devices’ networked operations. View

Device Design and Risk Management - Webinar CD/Transcript

$287.00
Medical device design is linked inextricably with risk management. Risk reduction measures become design inputs. Implementation verification, a risk management activity, can work as design verification too. View

Understanding the New EU Medical Device Regulations

$397.00
Understanding the New EU Medical Device Regulations directs you through the new MDR and in vitro diagnostic device regulations (IVDR) and explains the new provisions and what they’ll mean for your business. View

Brexit and Life Sciences Companies - Webinar CD/Transcript

$287.00
Your international drug and device business is at a crossroads known as ‘Brexit’ — the imminent departure of the United Kingdom (U.K.) from the European Union (EU). FDAnews has invited global drug-and-device expert Michael Burke Esq. to share his crystal ball. As law his firm’s in-house expert on drugs and devices as well as a specialist in cross-border international trade, Mr. Burke is uniquely qualified. View

Supplier Contracts for Non-Lawyers - Webinar CD/Transcript

$287.00
When it comes to supply contracts, it’s far better to do things right going in ... rather than pay the price down the road. In just 90 fast-moving minutes, Courtney Stevens Esq. of MedMarc Insurance Group walks you through the essentials of supply contracts — what to include, what to (safely) leave out, how to stand up for yourself. View

Internal Auditing Basics: A Guide for Drug and Device Manufacturers

$177.00
Internal Auditing Basics: A Guide for Drug and Device Manufacturers demonstrates how to build an auditing operation, including scheduling and reporting, explains regulatory requirements and discusses how to turn audit results into positive improvements. View