Digital Twin
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Successful Process Characterization – A How-to-Guide in 7 steps

Process validation (PV) aims at reassuring a manufacturer of constant product quality. Moreover, it is a regulatory requirement to achieve licensure of a pharmaceutical product Failing to efficiently plan and execute activities here leads to increased time-to-market. Statistics play a pivotal role here, as is shown by the fact that in the 22 pages of the latest FDA guidance document on process...

High Containment Manufacturing with Digital Integration

20 October 2020 - 23 October 2020
In fulfillment of our mission, ISPE Mexico Affiliate , has organized the first major official event, which will take place from 20 to 23 of October of the present with the assistance of recognized representatives of the sector. The event is made up...

Applying Baseline Guide 5 C&Q to a Paperless Validation System

15 October 2020 - 15 October 2020
Applying Baseline Guide 5 C&Q to a Paperless Validation System 15 Oct 2020 | 5 - 6.30pm | Online Pharmaceutical Manufacturers are required to demonstrate facilities, systems, utilities, and equipment are suitable for purpose. The ISPE Baseline Guide...

Steris Workshop: Cleaning Validation - Sterile Environments Regulatory Trends

10 November 2020 - 10 November 2020
STERIS Workshop Series Cleaning Validation - Sterile Environments Regulatory Trends 10 Nov 2020 | 8-9.30pm (SGT) | Online The FDA conducted approximately 17,671 inspections in Fiscal Year 2018, amounting to roughly 1400 inspections/month resulting in...

Robotics in Pharma

13 October 2020 - 13 October 2020
Complimentary Webinar for ISPE Members and Non-Members Robotics in Pharma Format: GoToWebinar Instructions to join will be emailed one day prior Program Manager: Merritt Postma, Director Western Region, SKAN US Moderator : Justin Cantor, Chief...
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