quality-risk qrm-tools 
ISPE
JULY 21, 2023
The first keynote presentation, “Smart Missions that Enable Innovation in High-risk Environments,” was delivered by Dr. Ed Hoffman, a senior lecturer at Columbia University who retired from NASA as a Senior Executive. Aerospace is healthier today at NASA and SpaceX by balancing risk and innovation.
European Pharmaceutical Review
AUGUST 25, 2023
The new guideline should help manufacturers gain clarity on how to benefit from new possibilities originating from the application of an enhanced process understanding by utilising innovative tools as described in the ICH guidelines Q9 and Q10. The former ICH guideline came into force on 26 July 2023.
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ISPE
JANUARY 30, 2023
The Ever-Changing Regulatory & Quality Landscape with Aseptic Processing Trudy Patterson Mon, 01/30/2023 - 10:54 iSpeak Blog iSpeak The Ever-Changing Regulatory & Quality Landscape with Aseptic Processing Michael G. will discuss the importance of avoiding creating individual risk assessments for each requirement of the CCS.
ISPE
FEBRUARY 3, 2023
Overall, participating in an industry benchmarking survey is a valuable tool for you or your company looking to gain a competitive edge and stay on top of industry trends. If you work in engineering, commissioning, qualification, validation or quality, or associated areas please take this survey.
ISPE
JUNE 23, 2023
Kulkarni, PhD 23 June 2023 The 2023 ISPE Annual Meeting & Expo features Manufacturing, Quality Control, and Operational Excellence as one of the key content areas. During the design implementation of biopharmaceutical manufacturing, GMP risk assessments and regulatory rationale must be applied to ensure the highest level of quality.
European Pharmaceutical Review
JANUARY 16, 2023
“Connectivity between the laboratory and manufacturing facility is growing, and the use of digital tools will continue to build that integration,” commented Miriam Guest. All require aseptic manipulation, hence have microbial contamination risks. The FDA is doing this through the publications of Guidance for Industry.
ISPE
JULY 6, 2023
Applying a systemwide risk management (SRM) approach to manufacturing is essential to ensuring manufacturing projects are vetted in a comprehensive and consistent manner. Understanding and managing these risks is central to any decision to greenlight CM in a production-ready environment.
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