The Netherlands Affiliate

Global News

03 October, 2024
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iSpeak Blog

Setup and Implementation of Digital Validation Tools

Think of implementing a digital validation tool (DVT) as being similar to building a new house. There are decisions that need to be made before starting to build a house:

02 October, 2024
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iSpeak Blog

Pharma 4.0™ Interconnected Facility Design and Construction

The pharmaceutical industry is on the verge of a profound transformation, driven by the digital advancements of Pharma 4.0™. This shift is set to redefine the design and

01 October, 2024
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iSpeak Blog

Data Integrity and Large-Scale Systems

This blog post will discuss the relationship between large systems that manage records at the multi-batch, multi-site level of operation and the data integrity of those
Global Events

OSD: Ops, Quality, Equipment and Tech (T10)

01 October, 2024

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Classroom Training

Oral Solid Dosage Manufacturing Process Training Course

This training course examines current technology and provides scenario-based exercises for system troubleshooting and investigational events for process deviations, discusses...

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HVAC for Pharma Facilities (T14)

02 October, 2024

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Classroom Training

HVAC & Environmental Control for Life Science Facilities Training Course

This training course focuses on common issues and problems in the operation of a facility and maintaining readiness for cGMP inspection. Topics include control system alarm...

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Pharmaceutical Technology Transfer (T19)

08 October, 2024

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Classroom Training

Pharmaceutical Technology Transfer Training Course

This training course on Pharmaceutical Technology Transfer identifies criteria for successful technology transfer and provides ‘how to’ examples which can be individually...

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Videos

23 September 2024
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Video

FOYA Category Honorable Mention: Zydus Pharmaceuticals Ltd.

The Zydus OSD project focused on process innovation and automation to scale up, reducing costs and turn-around times. It is for those reasons it has been recognized with an Honorable Mention for the 2024 ISPE FOYA...

16 August 2024
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Video

FOYA Category Social Impact: Chugai Pharma Manufacturing Co, Ltd

UK4 is a biological drug substance manufacturing facility that was designed and built under a “Three Zeros for Sustainable Development” concept. The three zeros encompass: 1) zero halogenated hydrocarbons, 2) zero...

5 August 2024
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Video

Attend the 2024 ISPE Annual Meeting & Expo

Attend the 2024 ISPE Annual Meeting & Expo Our comprehensive education program offers cutting-edge technical sessions, shedding light on the latest advancements in areas like supply chain, operations, facilities, and...

PIC/S in Latin America: Harmonization of cGMP Procedures

This article offers an overview of the benefits of Pharmaceutical Inspection Co-operation Scheme (PIC/S) membership for regulatory authorities and industry. It also highlights Latin American regulators’ current perspectives on PIC/S membership to increase awareness and...

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