How to select Software for a Regulated Environment

Duration: 120 Minutes
Software is widely used in our industry and selection of new software or upgrade of existing software is one of the activities that crop up every year in an IT department’s task list. Our industry, has the added challenge of being subject to both regulations that add another degree of complexity to this already complex task.
Software for Regulated Environment
Instructor: Angela Bazigos
Product ID: 500080
Why Should you Attend:
Buying software is a fact of life for most companies. There is fierce competition in the market, with multiple software vendors trying to convince to buy their product. How do you determine whether to buy the software or having it built in house? Or which vendor to choose? And if you buy something, how do you determine whether to have it hosted? And are there any regulations that apply to this software? And if so, what are they?

This presentation will give the answers to these questions; plus show you ‘hidden’ issues that will save you from:
  1. Selecting and implementing the wrong system that ends up costing more in trying to get a ‘square peg to fit in a round hole’ efforts, often resulting in cost and time overruns and finally ending up not being used by the user community.
  2. Duplicating data in systems with overlapping functionality resulting in both duplication of effort and higher incidence of errors
  3. Inadvertently acting as the vendor’s beta site
  4. Putting unnecessary work into meeting regulations
Even though this presentation focuses primarily on software, the hardware required will also be addressed.

Objectives of the Presentation:
  • To buy or to build?
  • Why not stay with the existing solution?
  • Who should be part of the evaluation and decision team?
  • What is involved in the assembly of selection requirements?
  • What is the vendor evaluation process?
  • How does the new software fit into your current environment without causing errors and duplication?
  • What are the regulatory requirements for:
    • An In-House Build Solution?
    • A Commercial Off The Shelf Solution?
    • A Hosted Solution
    • Hardware environment
    • Implementation Consultants?
    • How do you use Risk Assessment?
  • How do you manage consultants and vendors?
  • How do you leverage the vendors’ methodology?
  • How long does it take and what will it cost?
Who can Benefit:
  • CEO
  • Regulatory VP
  • Quality VPs
  • IT VPs
  • Database Administrators
  • System Administrators
  • Validation Specialists
  • Security Specialists
  • Regulatory Affairs professionals
  • Quality Managers
  • Quality Engineers
  • Small business owners
  • GxP
  • Consultants
$375
Recorded Session for one participant
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How it works
Live Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • The webinar joining link, username and password for joining the webinar will be updated on your OCP Account 24 hours prior to the webinar
  • Presentation handouts in Downloadable PDF format will be updated on your OCP Account 24 hours prior to the live session
  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Angela Bazigos, is the CEO of Touchstone Technologies Silicon Valley, Inc. "Knowledge is Power". She has 35 years of experience in the Lifesciences industry spanning GLP, GCP, GMP, Medical Devices & 21 CFR 11 and has a patent aimed at speeding up Software Compliance.

Ms. Bazigos is a Past President of PRCSQA, a member of the SQA CVIC, ASQ, DIA and RAPS. She works closely with the FDA on behalf of her clients. She consults to LifeScience Investment Groups as well as to Pharma / Biotech / Medical Device companies on compliance matters, including strategy, submissions, quality assurance and remediations following action by the FDA.

More recently, Ms. Bazigos co-authored Computerized Systems in Clinical Research / Current Data Quality and Data Integrity Concepts with FDA, DIA and Academia. She was on the board for UC Berkeley’s Business School for Executive Education in Life Sciences and is now on the Stanford Who’s Who Registry for contributions to the Lifesciences industry.
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