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2021 ISPE Annual Meeting & Expo

Concurrent Session: Improving Operations Through Efficiency


Nov 2, 2021 4:00pm ‐ Nov 2, 2021 5:30pm


Description

Concurrent Session: Improving Operations Through Efficiency|Digital work instructions are a tool that is becoming more and more prevalent. Digital work instructions can help personnel be more efficient while capturing critical data can allow manufacturing, QC, and warehouse managers to more quickly improve the way task steps are executed.   In this session, Improving Operations Through Efficiency, presenters from the manufacturing and software sides will discuss the IT challenges and the impact to business and regulatory to consider when implementing this exciting technology.  As quality and Digital Transformation become more important, Testing and SQA teams must adapt, changing compliance and documentation practices to adopt modern tools and methodologies. Many organizations struggle with how to make this transformation possible.  Utilizing a case study, one part of this session will discuss how to modernize software compliance to support digital transformation and the strategic adoption of a CSA model to improve efficiency while remaining compliant with regulatory bodies and your own Quality Organization. Additionally, GMP industry has been scrutinizing vendors/suppliers with more rigorous qualification programs to determine if they can provide the necessary goods or services to the standards that the GMP company requires. The Quality System approach calls for periodic auditing of suppliers based on risk assessment either by paper, on-site, or both even for processing aids such as cleaners, disinfectants and other Life Sciences consumables.  As part of this session, risk-based evaluations of process aids and how these may impact the process, assigning requirements based on risk level and industry trends for compliance for vendors of processing aids, will be discussed.

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