France Affiliate

ISPE France Affiliate compte environ 300 membres. L'association loi 1901 est pilotée par un Conseil d'Administration de 20 membres qui est responsable de l'animation des évènements organisés chaque année. En outre, le Conseil d'Administration représente l'ISPE France au sein des différents comités et groupes de travail d'ISPE International.

A Propos de l'Affilié

Conseil d'Administration

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Global News

13 May, 2021

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iSpeak Blog

Brexit: Economic Operators Registration and Identification Number and Duties and Taxes

Economic Operators Registration and Identification (EORI) Number Customs procedures also imply having an Importer of Record liable at destination as well as having each party...

12 May, 2021

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iSpeak Blog

Read, Learn, Innovate: Pharmaceutical Engineering® Top 5 Online Articles in April 2021

Featured in this edition of the Pharmaceutical Engineering Online Reading Roundup are the most read online articles during April 2021. Learn more about understanding...

11 May, 2021

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iSpeak Blog

Impact of Comprehensive Responses to Regulatory Actions on Sustainable Manufacturing Quality

Quality is the strongest force multiplier for any organization’s growth. Attaining higher quality levels has a multi-dimensional effect throughout any organization. Creating...
Global Events

17 May, 202117

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Classroom Training

Quality Management Systems Training Course

Through lecture and group exercises this course illustrates how quality systems work, the purpose of the different elements, how they connect to each other and how to...

22 June, 202122

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Classroom Training

Pharma Facilities Project Management Training Course

Specifically targeted to the needs of facility projects within the regulated pharmaceutical industry and demonstrates the value inherent in the use of “good practice” project...

28 June, 202128

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Classroom Training

GMP Fundamentals for the Pharmaceutical Industry

This course is designed to help participants understand the GMPs as they relate to the pharmaceutical industry. Participants will gather information about both European...
Videos

29 April 2021

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Video

503B Compounding Pharmacies: Principles, GMPs and Case Studies

Join us on 6 May 2021 for the FREE live webinar "503B Compounding Pharmacies: Principles, GMPs, and Case Studies" to take an in-depth look at how this field has developed since section 503B was created as part of the...

27 April 2021

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Video

Introducing the 2021 FOYA Category Winners

Technology and innovation in the pharmaceutical industry are more critical now than ever before as healthcare worldwide is straining from the COVID-19 pandemic. Even in these trying times, it is important to spotlight...

26 April 2021

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Video

What Are Some Critical Elements to Ensure Full Transparency between Industry & Regulatory Agencies?

The global pharmaceutical industry continues to face unexpected challenges in responding to the world’s pandemic. The impact on normal operations has been felt in companies of all sizes, with varying manufacturing...

Guidance Documents

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Good Practice Guide: Knowledge Management in the Pharmaceutical Industry

Good Practice Guide: Knowledge Management in the Pharmaceutical Industry

Published

May 2021

ICH Q10 outlines three objectives: achieve product realization, establish and maintain a state of control, and facilitate continual improvement. Embracing these objectives can be best achieved using the dual enablers, Knowledge Management (KM) and Quality Risk Management (QRM).

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Good Practice Guide: Maintenance 2nd Edition

Good Practice Guide: Maintenance 2nd Edition

Published

January 2021

Maintenance can impact both the quality of products and the compliance of pharmaceutical processes. Maintenance programs have long been recognized as critical to the success of the operations they support.

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Good Practice Guide: Equipment Reliability

Good Practice Guide: Equipment Reliability

Published

December 2020

Equipment reliability is concerned with the risk of failures in equipment and processes, providing focus on equipment availability, fitness for purpose, and cost. The strategy and tactics of reliability contribute to realizing the value of equipment throughout its useful life and mission.

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APQ Guide: Corrective Action & Preventive Action (CAPA) System

APQ Guide: Corrective Action & Preventive Action (CAPA) System

Published

November 2020

The ISPE APQ Guide: Corrective Action and Preventive Action (CAPA) System provides a quality management framework for assessing and advancing CAPA system maturity level by evaluating several key components.

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IT Services: Applying Good It Practice & Automation

Pharmaceutical Engineering Magazine

This article focuses on pragmatic quality- and risk-based approaches to IT infrastructure. It covers recommendations made by a US FDA/industry team linked to the US FDA Center for Devices and Radiological Health (CDRH) Case for...

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Pharmaceutical Engineering May / June 2021 Cover

France Affiliate

France Affiliate

Guidance Documents

Good Practice Guide: Knowledge Management in the Pharmaceutical Industry

Good Practice Guide: Knowledge Management in the Pharmaceutical Industry

Good Practice Guide: Maintenance 2nd Edition

Good Practice Guide: Maintenance 2nd Edition

Good Practice Guide: Equipment Reliability

Good Practice Guide: Equipment Reliability

APQ Guide: Corrective Action & Preventive Action (CAPA) System

APQ Guide: Corrective Action & Preventive Action (CAPA) System

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