Tags » FDA Regulations

Live webinar on FDA’s 21 CFR Part 11 Add-on Inspections

In December 2010 the FDA began a project to better understand the industry’s adherence (or lack thereof) to 21 CFR Part 11. This involves the add on’ surveillance inspections of the sponsors’ computer systems during the course of the FDA’s regular inspections. 261 more words

Life Science

Webinar On Part 11 Compliance Simplified: Easy, Cheap and Fast Steps to Meet FDA Requirements

This webinar will discuss the Part 11 requirements and practical techniques for evaluation of the current compliance status of a given organization. You will hear about validation requirements, system security protocols, rules for building computer networks, adding new components to network, back-up of data, access control, rules for passwords, and audit trails. 377 more words

Fda Requirements

Why is Computer System Validation Important in FDA Regulated Industries?

Asking why Computer System Validation (CSV) is important in FDA-regulated industries is like asking why an engine is important to a vehicle.

Before going on to get an understanding of this issue, let us understand that there is a difference between the ways in which the term “validation” is used in the general area of computers and that used in FDA-related circles. 367 more words

Fda Compliance

The Future of Medical Device Manufacturing

As companies work to comply with changing regulations in the Medical Device industry, there is an opportunity to improve production and revenue for the savvy manufacturer… 1,067 more words


FDA suggests social media standards for pharma and med device companies

The FDA issued a pair of guidelines on Tuesday for pharmaceutical and medical device companies regarding the use of social media and internet communication for medical products. 526 more words

Property & Casualty

Free to Vape, Get the Word Out

Okay, sorry about ignoring my blog.  The last month has been a bitch.  This will be a quickly.  FDA rules are out, some good news, some bad news.   104 more words