Inspections and Audits

ARTICLES

483 Roundup: FDA Targets Eight Device Facilities

The FDA cited eight device firms for a range of compliance issues including inadequate complaint procedures, lack of written quality procedures, shipping products prior to approval, inadequate documentation, and unreported software changes. Read More

Key Elements for a Successful Internal Audit

Responses to internal audit reports are critical for GMP compliance because they fall under CAPA — so how a company responds to the findings of an internal audit is a key component of an effective audit. Read More

PRODUCTS

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

Dealing with China’s Regulatory Authorities: Tips for Devicemakers

$177.00
Dealing with China’s Regulatory Authorities lays out the whole regulatory map — explaining which bodies are responsible for which groups of products and activities, what their particular interests are, how to deal with officials at different levels and what personal factors (education level, language, culture) should be taken into account. 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

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

Guide to FDA and EU Medical Device Regulations, 2017 Edition

$397.00
NEW for 2017 — You’ll get the full text (more than 1,000 pages) of the European Union’s newly revised regulations for medical devices and in vitro diagnostic devices. View

Creating QSR-Compliant CAPA Systems: A Practical Guide for Devicemakers

$397.00
Creating QSR-Compliant CAPA Systems provides you with a comprehensive knowledge of CAPA management that will help you avoid trouble. View

Investigations Operations Manual 2017

$377.00
Don’t wait for FDA investigators to tell you what their new focus is when they’re already at your facility. Get a heads up with Investigations Operations Manual 2017. View

Top 5 Reasons to Use the Medical Device Single Audit Program - Webinar CD/Transcript

$287.00
The Medical Device Single Audit Program, or MDSAP, is skyrocketing in popularity as devicemakers discover its many advantages. Already 229 devicemakers have adopted it — 72 in this quarter alone. In just 90 minutes, Brian Ludovico of MDSAP Regulatory Certification will show you how to begin your MDSAP participation. View

The FDA Under a New Commissioner - Webinar CD/Transcript

$287.00
Likely new FDA Commissioner Scott Gottlieb is an old agency hand thrust into a new role. Will he toe the Trump line ... or show independence? Is his past a guide ... or will he strike out in new directions? Will he ease new drug and device approvals ... or toughen them? Increase inspections ... or ease off? More 483s and warning letters ... or fewer? View

Detecting Trends in Medical Device Complaints - Webinar CD/Transcript

$287.00
When device users complain, those complaints must be passed on – to the FDA, the EU and other regulators. The FDA’s QSR. International standards ISO 13485:2003 and ISO 13485:2016 ... The EU Vigilance system and the draft EU Medical Device Directive (MDR) ... Couldn’t you use help with your complaint reporting systems? View