As regulatory agencies invite public comment on a new or revised regulation or guidance they look to ISPE for input on the latest scientific and technical developments. ISPE submits official comments when we can provide...
iSpeak Blog

In 2024, the Facility of the Year Awards (FOYA) honored Zydus Pharmaceuticals with an Honorable Mention for their state-of-the-art Oral Solid Dosage (OSD) manufacturing facility in Ahmedabad, Gujarat, India. This recognition highlights Zydus’s commitment to innovation, efficiency, and patient accessibility within the pharmaceutical industry.

21 January 2025 - 21 January 2025
The Northeast Women in Pharma (WIP) Committees present a three-part virtual series, emphasizing three keys to continuing to advance your career. This virtual, online-only program is brought to you by the Women in Pharma (WIP) Committees but is open...
29 January 2025 - 29 January 2025
Please plan on joining us at Merck's Upper Gwynedd campus for an interactive discussion on the implementation of Artificial Intelligence with an emphasis on GxP and GxP-adjacent applications. PLEASE NOTE: Space for this program is limited to 32...
iSpeak Blog

ISPE has announced the new 2024-2025 ISPE Affiliate and Chapter Council Chairs and Co-Chairs. ISPE Regional Affiliate Councils collaborate efficiently with the international ISPE organization and local regional peers to ensure optimal alignment and support for local success. ISPE currently has three regional affiliate councils including: Asia-Pacific Affiliate Council (APAC), European...

iSpeak Blog

In 2020, CSL initiated a benchmarking activity with a small group of peer companies identified through ISPE to explore creation and maturation of Asset Management programs at each company. The initial sessions were a success, covering topics such as Asset Condition Evaluations and Asset Management Governance. CSL was keen to continue the conversations and gather more insights on certain...

iSpeak Blog

Advanced therapy medicinal products (ATMPs) are medicines based on genes, tissues, or cells. This class of products cannot be terminally sterilized and, in many cases, cannot be filtered and are manufactured by Aseptic processing. The increase in demand for these life-changing products has been fraught with technical and regulatory challenges as laboratory processes are scaled to commercial...

iSpeak Blog

ISPE’s Pharma 4.0™ Baseline Guide authoring team received the prestigious Committee of the Year Award, as part of the 2024 ISPE International Honor Awards which were presented at this year’s 2024 ISPE Annual Meeting & Expo., The Committee of the Year Award recognized the Pharma 4.0™ Baseline Guide Authoring Team for their...

16 January 2025 - 16 January 2025
Data and Data Integrity – Identifying, Assessing and Protecting Your Data What is “data” – or "metadata"? What data is important? When does a “system of record” become necessary? You need to understand your organization’s data, it’s impact and how to...
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