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Consistent Measurements from Lab-to-Process Improve Production

ISPE

Consistent Measurements from Lab-to-Process Improve Production. Sat, 10/01/2022 - 06:00. Consistent Measurements from Lab-to-Process Improve Production. 1 October 2022. You may unsubscribe from these ISPE communications at any time. Trudy Patterson. Sponsored Content. Leave this field blank.

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Oligonucleotides: A Cornerstone for Therapeutics & More

ISPE

Thu, 10/27/2022 - 14:16. November / December 2022. 1 November 2022. In this article, we’ll explore some innovations and improvement opportunities in the science, manufacturing processes, and facilities that produce these therapies. 2 (February 2022): 260. 10 (10 June 2022): 5443–66. Trudy Patterson.

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Doctoral Capstone Presentations

Blog: Ask a Student Pharmacist

FAQs for sites that provide OT services FAQs for Community Sites with No OT services Capstone Presentations 2023 Expand all + Research Focused Experience Studying the Reliability and Precision of the Intermetacarpal Distance Method in Persons with Thumb Osteoarthritis Research_ Test-Retest Reliability of the GripAble Device Interrater Reliability Measures (..)

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Environmental Sustainability in Biopharmaceutical Facility Design

ISPE

linear) design process is central to successfully attaining such comprehensive sustainability goals and project needs (see Figure 1). Accessed 3 December 2022. 7 November 2022. www.weforum.org/agenda/2022/11/3-ways-healthcare-systems-carbon-footprint/ 5 European Commission. Accessed 3 December 2022. Washington D.C.:

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A Proposal for a Comprehensive Quality Overall Summary

ISPE

Challenges with the Current Module 2 Structure The US FDA published a white paper in 2018 calling for a revision to Module 2 because, “there can be a disconnect between applicants and regulators regarding the communication of quality data and its impact on the assessment. Currently, it takes time and/or communications (e.g.,

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A Proposal for a Comprehensive Quality Overall Summary

ISPE

Challenges with the Current Module 2 Structure The US FDA published a white paper in 2018 calling for a revision to Module 2 because, “there can be a disconnect between applicants and regulators regarding the communication of quality data and its impact on the assessment. Currently, it takes time and/or communications (e.g.,

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Streamlining Postapproval Submissions Using ICH Q12 & SCDM

ISPE

Mon, 08/29/2022 - 15:46. September / October 2022. 1 September 2022. HC is expected to have full implementation of ICH Q12 by late 2022. Reader note: This article was initially submitted to Pharmaceutical Engineering® during December 2021/January 2022. Streamlining Postapproval Submissions Using ICH Q12 & SCDM.