The Compliance Authority Synopses

Software Vendor Audits – By Michael Gregor, President, Compliance Gurus Inc

Introduction

A software vendor audit is a prerequisite to using a software application for regulatory purposes. In this article, I will explain the importance of performing software vendor audits, some of the challenges, and what areas to target during an audit. Software vendor audits are an integral part of your quality system. There are two reasons why software vendor audits are an integral part of your quality system. First, software vendor audits are a requirement of the quality system. Secondly, software applications either have a direct impact to patient safety or an indirect impact to patient safety. The second point leads us into why software vendor audits are so crucial.

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Computer System Validation:FDA Inspections – By Michael Gregor, President, Compliance Gurus Inc

Introduction

Is your organization ready for an inspection of your Computer System Validation program? In this article, I will offer some key tips on how to prepare for an inspection of your computer system validation (CSV) program. Often times, the FDA comes to inspect your facility for reasons other than your CSV program. However, because so many of our business processes are governed by electronic systems, the topic of Computer System Validation inevitably comes up during the course of an inspection. As a result of an increase in federal investigators, investigators are able to inspect more facilities and dig deeper into areas such as Computer System Validation.

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Medical Device Company, Regulations, Limited Resources

Compliance Gurus had the unique opportunity to work with a small medical device company located in Massachusetts. The company was faced with many challenges. The first challenge was they wanted to get their product on the shelves of a major retailer. However, in order to do so, they had to pass a series of GMP audits by a third party contracted out by the retailer. Compliance Gurus Inc. was called in at this point to help assess and prepare for the audit. The second challenge the company faced was they had no QA department and very little understanding of the Code of Federal Regulations, especially 21 CFR Part 820. The third challenge the company faced was a lack of resources. These three challenges combined, made the task at hand seem impossible at first.

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What Are The Next Generation Cyber-Security Threats & Business Compliance Risks and How to Deal With Them

Why Should You Attend:

Security breaches are leaving a trail of huge losses – for businesses and individuals. As per a market survey done in 2009, corporations have lost US$1 Trillion worldwide as a result of data loss, accidental and malicious. No segment remains untouched – retail, technology firms, medical industry, and even the government and defense. This webinar will discuss the present and future cyber-security threats and business compliance risks and what you can do to protect your business against them. We will also discuss how to keep things organized while deploying tools and technologies to deal with threats, regulations and IT operational issues.

Who Should Attend:
Enterprises and members dealing with Information Security and Compliance issues.

Webinar Details:
Date: May 20, 2010.
Time: 10:00 AM - 11:00 AM PDT.

Presenters:

• Anupam Sahai, President, eGestalt Technologies, Inc.
  Anupam is an accomplished management, marketing, and technology leader, with 21+ years of experience, directing teams of up to 50 professionals to develop and launch globally-renowned products, He has a Bachelors degree in Engineering from IIT Kharagpur, INDIA, Masters in Computer Science from IIT Kanpur, INDIA and a Masters in engineering plus an MBA from Sloan School of Management, both from MIT, Cambridge, MA. He has to his credit three world-wide patents, has published 10 technical papers and is a featured speaker at several industry conferences worldwide.


• Dr. Anton K Chuvakin, Technical Advisory Board Member, eGestalt Technologies Inc, USA.
  Anton is a recognized security expert in the field of log management and PCI DSS compliance. He is an author of books "Security Warrior" and "PCI Compliance" and a contributor to "Know Your Enemy II", "Information Security Management Handbook" and others. Anton has published dozens of papers on log management, correlation, data analysis, PCI DSS, security management. His blog "Security Warrior" is one of the most popular in the industry. He works on emerging security standards and serves on the advisory boards of several security start-ups. Currently, Anton is developing his security consulting practice, focusing on logging, SIEM, IT GRC and PCI DSS compliance. Anton earned his Ph.D. degree from Stony Brook University.

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