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.
Why should you attend/Description of the topic:
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:
- 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.
- Duplicating data in systems with overlapping functionality resulting in both duplication of effort and higher incidence of errors
- Inadvertently acting as the vendor’s beta site
- Putting unnecessary work into meeting regulations
Even though this presentation focuses primarily on software, the hardware required will also be addressed.
Areas Covered in the Session:
- 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 will 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 |
Instructor Profile
Angela Bazigos is the CEO of Touchstone Technologies Silicon Valley, Inc. “Your Passport to Compliance”. She has 30 years of experience in the Lifesciences 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. She teaches classes on Compliance, 21 CFR 11, Computer Systems Validation, and Project Management both to investor groups and industry. More recently, Ms. Bazigos co-authored Computerized Systems in Clinical Research / Current Data Quality and Data Integrity Concepts with FDA, DIA and Academia. She is on the board for UC Berkeley’s Business School for Executive Education in Life Sciences and on the Stanford Who’s Who Registry for contributions to the Lifescience industry
Live Session for one participant
Price: $225.00
Corporate Live Session 4 to 10 participants in single location.
Price:$885.00
Recorded Session Access recorded sessions only for one participant unlimited viewing for 6 months.
Price: $275.00