Webinar On Project Management for Computer Systems Validation

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Project Management for Computer Systems Validation
Product Id
IT1058
Category
IT Compliance
Scheduled On
Thursday, July 10, 2014 at 1300 Hrs
Duration
120 Minutes
Speaker
Angela Bazigos

To register for this webinar please visit
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• Webinar Description

Project Management is defined as the planning and
organization of an organization's resources in
order to move a specific task, event or duty
toward completion. However, Validation of
Computerized Systems has a very specific set of
tasks that are often mismanaged, resulting in
missed deadlines, increased costs, and regulatory
risk, and missed times to market for a companys
product. Per the CDRH, 20 of product recalls in
the medical device industry are due to faulty
software!!! Yet, these human, financial and
reputation capital expensive issues, can be
averted with computerized systems validation and
21 CFR 11 compliance. The Project Manager for a
Validated Computerized System, has to deliver on
time and on budget, but with the added risk of
having to meet regulatory compliance, often
causing project overruns, regulatory findings and
missed times to market. This detailed webinar
will explain the basic tenets of project
management, the basic tenets of 21 CFR 11
compliance for Computer Systems Validation and
will show how to marry the two, to deliver on
time and on budget while meeting regulatory
compliance requirements in a more effective
manner.

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Area Covered In The Session

• Basics of Project Management
• 21 CFR 11 and Computer Systems Validation (CSV)
• Project Planning for a Computer Systems
  Validation Project
• CSV Deliverables
• Hiddent CSV Deliverables
• Metrics Gantt Charts
• Common Pitfalls and How to Avoid them
• The 10 Deadly Sins!!

Who will benefit

• Project Managers
• IT Management
• Business Process Owners
• Quality Managers
• Quality Engineers
• GxP
• Consultants

• Speaker Profile

Angela Bazigos is the CEO of Touchstone
Technologies Silicon Valley, Inc. Your Passport
to Compliance. She has 30 years of experience in
the Life sciences industry spanning Project
Management, Quality Assurance and Regulatory
Affairs and has a patent aimed at speeding up
Software Compliance. Ms. Bazigos is the president
of PRCSQA (Pacific Regional Chapter of the
Society of Quality Assurance) a member of the SQA
CVIC (Society of Quality Assurance Computer
Validation Initiative Committee), ASQ, DIA and
RAPS and consults to Pharma / Biotech / Medical
Device companies as well as investment groups on
compliance matters, including strategy,
submissions, quality assurance and remediations
following action by the FDA. 
To know more visit https//compliancetrainings.
com/SiteEngine/ProductDetailView.aspx?idIT1058