2019 - Auditing the Software Development Life Cycle (SDLC) at GCP System Suppliers

OVERVIEW
This 60-minute webinar course answers the following questions:
What kind of documented evidence do auditors and inspectors look for and expect software suppliers to produce to support their product's level of quality to GCP, Part 11, and Annex 11 standards?
How can Modified Waterfall and Agile software development methodologies be documented in a way that does not hold back project timelines?
How should software suppliers prepare themselves to successfully host audits and inspections?
How do you host, manage, and document the customer audit experience?
LEARNING OBJECTIVES
This presentation aims at teaching participants about:
Regulatory impact on software development by ICH GCP, FDA Part 11, EMA Annex 11
Quality gates for Modified Waterfall and Agile software development methodologies
Standard set of verification documentation to successfully support audits/inspections
Managing the audit/inspection process
WHY SHOULD YOU ATTEND
This course teaches you the auditor/inspector view of software development practices. It does not teach you how to develop software, but it does teach you how to provide documented evidence for quality gates in the software development process and formal testing practices.
Dr. Stokes has more than 20 years of experience auditing software suppliers on behalf of pharmaceutical clients and also helping software suppliers to establish auditable Quality Management Systems in their organizations to GCP/Part11/Annex 11 standards.
WHO WILL BENEFIT?
Software Developers, Testers, and other Supplier professionals new to the GCP regulated the market
QA/QC and IT professionals new to software development practices in the GCP regulated market
System purchasers/Owners and other professionals new to the software GCP audit experience
Developers of EDC, Diary/EPRO, IVRS/IWRS, and other clinical trial systems
SPEAKER
Dr. Teri Stokes has worked as a Medical Technologist in hospitals, researches, and central laboratories. Her transition to computers came from troubleshooting systems reporting laboratory results. She joined Digital Equipment Corporation (DEC) for a 16-year career focused on pharmaceutical computer solutions.
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