PDA Pacific Northwest Chapter: Use Computerized Tools to Support & Elevate Your Stability Program
Registration Options
Individual Registration
Group Registration
This is an in-person and virtual event! Please see Agenda for details.
Gain a better understanding of supporting stability programs with computerized tools. This presentation will begin by mapping out the flow of data within the Stability process considering manual or digitized formats. Data Integrity (DI) requirements (FDA, MHRA, EMA, and PICS) will be reviewed and applied to the individual workflow steps. This includes defining metadata, au-dit trails, static vs dynamic forms, cGMP records, access rights, generation of data, retention of data, data use for decision-making, data archival, and electronic signatures. A risk assessment, including DI considerations, on the mapped stability process workflow will be shown using DI requirements and computerized tools to improve the Stability process workflow.
Student and Early Career Professional discounts available. Reach out to: contact@pdapnw.org
Event Location
22505 WA-9, Woodinville, WA 98072 Get DirectionsContact
Chapter Inquiries
Membership Services
Standard Registration
Member Price
$50.00Non-Member
$60.00
Virtual
Member Price
$20.00Non-Member
$25.00
Day 1
- 5:30pm | Doors open
- 5:30 pm - 6:00 pm | Networking
- 6:00 pm - 7:00 pm | Dinner
- 6:15pm - 8:00 pm | Virtual meeting open
- 6:30 pm - 8:00 pm | Presentation
- 8:00 pm - 8:30 pm | Closing and final networking
Zoom meeting information coming soon.
Featured Presenters
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Sheba S. Zaman
Head of Product Specialists and Training Services, Novatek International
Read Bio
Sheba S. Zaman
Novatek International
Sheba Zaman has been serving in a technical role at Novatek International for over 20 years. With degrees in both Health Science and Computer Science, she is an expert in the management of critical pharmaceutical computer systems such as Contamination Control, Environmental and Utility Monitoring, Cleaning Validation, LIMS, Stability and Quality Management Systems. Currently Head of Product Specialists and Training Services, she is experienced in helping companies manage and analyze their analytical data. She has worked with clients globally for over a decade managing change and implementation of software solutions, including process mapping, establishing procedures, work instructions, validation scripts and training programs. Key areas of expertise include Data Integrity, Process Improvement, Data Analysis/Trending, regulatory compliance, software Implementation and optimization in a regulated environment. She also teaches PDA tri/ISPE/KENX courses for various contamination control topics and formerly served as the President of Parenteral Drug Association’s (PDA) Southern California Chapter.
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