Need New Software? Choose the Right Vendor for Your Business Needs

Live Webinar

  • 90 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.

Session Highlight:

  • 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?

Why You Should 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.

Who Should Attend:

  • 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

*You may ask your Question directly to our expert during the Q&A session.

** You can buy On-Demand and view it as per your convenience.

Angela Bazigos

Angela Bazigos

Angela Bazigos, is the CEO of Touchstone Technologies, Inc. She has 40 years of experience working in hospitals and Pharma industry. Her background includes companies like Roche, Novartis, Genentech and PricewaterhouseCoopers in GLP, GCP, GMP, Medical Device and Data Integrity Roles. She has held positions such as Chief Compliance Officer, QA Director and has acted on behalf CEO for communications with FDA. 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 Life Science Investment Groups as well as to Pharma / Biotech / Medical Device companies on compliance matters, including strategy, submissions, quality assurance and remediation following action by the FDA. Has contributed to prototyping of 21 CFR 11 & CSV before promulgation to industry. Ms. Bazigos co-authored Computerized Systems in Clinical Research / Current Data Quality and Data Integrity Concepts with FDA, DIA and Academia. She holds a patent in speeding up software validation. She has been 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 Life Sciences industry.

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