New Proposed Auditing Course: Considerations for an eData Quality Audit Program

We’ve submitted this course proposal for the April SQA Quality College in Anaheim. Feedback has been good, but even if it isn’t picked up for this venue…it will eventually happen *somewhere*:

Instructors: Timothy J. Kuhn and Conrad Kawaguchi

Target Audience: Seasoned Auditors with little eData/CSV experience or CSV professionals with little auditing experience.

 Course Objectives

• Establish and differentiate between the eData Audit Function and the Operational CSV Quality Roles.

• List the considerations for the GxP eData Audit Program (Contributing to other GxP Audits, Independent Focused Data Integrity Audits, etc.)

• Explore the various roles that the eData Auditor may serve as part of an audit (SME, Co-Auditor, Audit Lead)

• Define and list the desired skill set for the eData Audit Team

• Break down the various types of audits and risk areas for each: GLP Labs, Central Clinical Labs, Central Readers (eCG, Imaging, etc.), ePRO (Electronic Patient Reported Outcomes – AKA Diaries), Acquisition Due Diligence, GMP Manufacturing Sites and Vendors, PV, eSystem Validation, Databases, IT Infrastructure, Cloud Providers, Software Providers, SaaS vendors, Pharma, Device, Combo Product, and others.

Course Description: Electronic Data (eData) is pervasive in the GxP world and auditors in that GxP eData space need to understand what is most important in these areas. This course will explore considerations in establishing an eData audit program, give auditors with little Technology/eData/Computer System Validation(CSV)/IT saavy the understanding needed to assess the eData/eSystems they encounter in the course of their existing GxP audits, and expand the understanding of eData auditors beyond the software vendor audit so as to know what is most important in GxP audits. The course will demonstrate “what to look for” for a variety of audits, both technology-focused and more conventional areas in which technology has “encroached”.

 

~TJK

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Equifax Breach

Equifax says a giant cybersecurity breach compromised the personal information of as many as 143 million Americans — almost half the country.

 

http://money.cnn.com/2017/09/07/technology/business/equifax-data-breach/index.html

 

 

NIH: Robotic Exoskeleton Could Be Right Step Forward for Kids with Cerebral Palsy

This is very cool!

#VeryCool

Robotic Exoskeleton Could Be Right Step Forward for Kids with Cerebral Palsy
09/05/2017 09:55 AM EDT
https://na01.safelinks.protection.outlook.com/…

More than 17 million people around the world are living with cerebral palsy, a movement disorder that occurs when motor areas of a child’s brain do not develop correctly or are damaged early in life. Many of those affected were born extremely prematurely and suffered brain hemorrhages shortly after birth. One of the condition’s most […]
Robotic Exoskeleton Could Be Right Step Forward for Kids with Cerebral Palsy
09/05/2017 09:55 AM EDT

More than 17 million people around the world are living with cerebral palsy, a movement disorder that occurs when motor areas of a child’s brain do not develop correctly or are damaged early in life. Many of those affected were born extremely prematurely and suffered brain hemorrhages shortly after birth. One of the condition’s most […]

More than 17 million people around the world are living with cerebral palsy, a movement disorder that occurs when motor areas of a child’s brain do not…
DIRECTORSBLOG.NIH.GOV

FCC votes to “unlock the cable box”

I like seeing disruption in the technology sphere from the technology side rather than the regulatory side. It happened to be the Republicans on the regulatory side, but the Dems have their days too.

~TJK

http://arstechnica.com/business/2016/02/fcc-votes-to-unlock-the-cable-box-over-republican-opposition/

 

FCC votes to “unlock the cable box” over Republican opposition

Customers should be able to watch TV on any device without CableCard, FCC said.

The Federal Communications Commission today approved a Notice of Proposed Rulemaking (NPRM) that seeks to give consumers more choices in the set-top boxes they use to watch cable TV.

The vote was 3-2, with Chairman Tom Wheeler and fellow Democrats Mignon Clyburn and Jessica Rosenworcel voting in favor of the proposal, while Republicans Ajit Pai and Michael O’Rielly voted against. An NPRM is not a final vote. Instead, this will kick off a months-long public comment period leading up to a final vote that is likely to happen before the end of this year…..

Sharepoint White paper on Part 11

As published by Microsoft

SharePoint 2013 Configuration Guidance for 21 CFR Part 11 Compliance

Thoughts?

~TJK

 

Part 11 Cloud Compliance Course

 Timothy J. Kuhn

Timothy J. Kuhn: I’m not affiliated with the provider of the course as you may have surmised. I’ve been looking for a course for some of my team members and this came up in my feed so I thought I’d share. It looks useful; has anyone else taken it?

Best,

TJK

“21 CFR Part 11 Compliance for SaaS/Cloud Applications” has been pre-approved by RAPS as eligible for up to 12 credits

Key Focus:

Agenda: http://www.complianceonline.com/21-cfr-part-11-compliance-for-saas-cloud-applications-seminar-training-80202SEM-prdsm?channel=Nisha_OB

LA Hospital Pays Hackers Nearly $17,000 To Restore Computer Network : The Two-Way : NPR

On security…

LA Hospital Pays Hackers Nearly $17,000 To Restore Computer Network

Updated February 18, 201610:36 AM ET
Published February 17, 20169:08 PM ET
LAURA WAGNER
The Hollywood Presbyterian Medical Center was hacked for ransom earlier this month.
The Hollywood Presbyterian Medical Center was hacked for ransom earlier this month.

A Los Angeles hospital paid a nearly $17,000 ransom to hackers who breached and disabled its computer network, the hospital said in a statement LA Hospital Pays Hackers Nearly $17,000 To Restore Computer Network

The Hollywood Presbyterian Medical Center was hacked for ransom earlier this month.
Junkyardsparkle via Wikimedia Commons
A Los Angeles hospital paid a nearly $17,000 ransom to hackers who breached and disabled its computer network, the hospital said in a statement Wednesday…

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