Jan 21 2010

Computer Validation Audits: A Primer for Successful Execution

Category: Uncategorized @ 11:00 am

Webinar-  Computer Validation Audits: A Primer for Successful Execution
Thursday, January 21, 2010 11:00am – 12:00pm -Eastern Daylight Savings Time

INSTRUCTOR: Eric Henry, Senior Manager, Corporate Software Quality, Boston Scientific

Software Validation in an FDA-regulated Company

bonus: Audit Checklist Outline: Areas to Consider When Performing an Audit

 REGISTER NOW $149.00


Dec 10 2009

Surviving a Regulatory Inspection: The Do’s and Don’ts

Category: Audits, Live Events, Uncategorized @ 2:00 pm

Surviving a Regulatory Inspection: The Do’s and Don’ts

Live Web Training Course
Thursday, December 10, 2009
1:20 p.m. EST

Instructor: Kim Huynh-Ba
Register Now  $345


Dec 02 2009

Computer Validation Audits: A Primer for Successful Execution

Category: Audits, Live Events, On Demand Event, Uncategorized @ 8:05 am

Webinar-  Computer Validation Audits: A Primer for Successful Execution
Wednesday, December 2, 2009
11:00am – 12:00pm -Eastern Daylight Savings Time-United States

INSTRUCTOR: Eric Henry, Senior Manager, Corporate Software Quality, Boston Scientific

Software Validation in an FDA-regulated Company

bonus: Audit Checklist Outline: Areas to Consider When Performing an Audit

 REGISTER NOW $149.00


Nov 10 2009

Writing SOPs for Software Process Validation

Category: Standards, Uncategorized @ 1:45 pm

Webinar- Writing SOPs for Software Process Validation
Ensuring Line-by-Line Project Compliance and Traceability
Tuesday,  Nov.  10,  2009  •  1:30 p.m.  - 3:00 p.m. EST
INSTRUCTOR: Eric Henry, Senior Manager, Corporate Software Quality, Boston Scientific


Nov 08 2009

FDA’s new enforcement initiative – Strategic Software Validation Planning for Executives and Managers

Category: FDA, Uncategorized @ 1:06 pm

Webinar- This Software Validation training will discuss how to approach Strategic software Validation planning so as to satisfy FDA by complying to new enforcement initiative by FDA.

Instructor:  Alfonso Fuller, Esq. is the attorney-founder and President of Fuller Compliance, LLC, a consulting firm that specializes in FDA quality system, software quality and software validation for pharmaceutical, biotech and medical device companies.

More information and purchase   $299


Nov 02 2009

Managing Project Fraud Risk Through the PMO for Project Team Safety

Category: Project Management, Uncategorized @ 9:37 pm

PMO Series Webinar #07:  Managing Project Fraud Risk Through the PMO for Project Team Safety

Presenter:  Steve Rollins, MBA, PMP, PMOC, is a global subject matter expert in Project and Program Management, Project Fraud Management, Portfolio Management, and associated Metrics.

More information and purchase:  $10.00


Oct 28 2009

Using Risk Management Results to Organize Validation Efforts for Medical Device Software

Category: Risk Management, Uncategorized @ 12:17 pm

Using Risk Management Results to Organize Validation Efforts for Medical Device Software
Thursday, 09/18/2008
1:00 PM, USA Eastern 1 Hour Free
Presented by David A. Vogel, Ph.D. and Robert E. Barrett, Intertech Engineering Associates, Inc.

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Oct 14 2009

IEC 62304

Category: Standards, Uncategorized @ 5:43 am

IEC 62304


Oct 13 2009

CFR 820 Part 11

Category: Part 11, Uncategorized @ 7:32 pm

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Sep 24 2009

Software Supplier Audits: It’s Not Just About Compliance

Category: Audits, Uncategorized @ 7:07 pm

Recorded: Thursday, September 24, 2009
11:00am – 12:00pm -Eastern Standard Time-United States

Instructor – Eric Henry, Senior Manager, Corporate Software Quality, Boston Scientific Continue reading “Software Supplier Audits: It’s Not Just About Compliance”


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