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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WHO: GOOD DATA AND RECORD MANAGEMENT PRACTICES

Some good stuff in this guidance….particularly the bit on True copies…..

GUIDANCE ON GOOD DATA AND RECORD MANAGEMENT PRACTICES (SEPTEMBER 2015) DRAFT FOR COMMENT

True copy: A true copy is a copy of an original recording of data that has been certified to confirm it is an exact and complete copy that preserves the entire content and meaning of the original record, including in the case of electronic data, all metadata and the original record format as appropriate.

Full Guidance:  http://www.who.int/medicines/areas/quality_safety/quality_assurance/Guidance-on-good-data-management-practices_QAS15-624_16092015.pdf

Vaccines, Real Medicine

I’m so tired of #Homeopathabullshit….

~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…

Computer Inspection Checklist from PMDA

I’m not a big fan of using checklists during audits, but it is always good to see which ones are being used by the regulators to better understand their thinking and priorities. This one from Japan came up during the quarterly Society of Quality Assurance CVIC (Computer Validation Initiative Committee) on which I sit.

PMDA Checlist CSV

 

~TJK

FDA FY 2010 Inspectional Observation Summaries

The FDA has recently updated their published  483 inspection results here. This is really a great resource as it breaks the findings down by regulation and how often it was cited. The link is to the 2010 483 that I stumbled upon. The parent site has multiple years and in sortable formats:

http://www.fda.gov/ICECI/Inspections/ucm250720.htm

~TJK

 

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