Nordic Affiliate

Chapter News

11 July, 2020

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News & Press Releases

Upcoming events at the Nordic ISPE affiliate

ISPE Nordic is currently planning the following events: Computerised Systems Validation – expectations from the authorities – coming in end October The robots are coming...
Global Events

25 January, 202125

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Classroom Training

Aseptic Processing & Annex 1 Training Course

This 2-day course will focus on aseptic processing and quality management around the most important pharmaceutical technology.

11 February, 202111

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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...

15 February, 202115

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Classroom Training

HVAC cGMP Regulations 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...
Videos

14 January 2021

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Video

ISPE: Join a Global Pharma Community

An ISPE Membership gives you the opportunity to be a part of a community of 18,000+ global pharma professionals, working together to advance the solutions that lead to improved patient health. It’s essential that you're...

13 January 2021

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Video

Join the Discussion: 2021 ISPE Aseptic Conference

The ISPE Aseptic Conference has been setting the pace for 30 years, and the immersive digital experience in 2021 will not disappoint. We are building into the program extended Q&A/discussion time so that we can go into...

17 December 2020

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Video

2020 Season's Greetings: A Message from Tom Hartman, ISPE President & CEO

It is that time of year when many of us will start to reflect on the past 12 months and come together with family and friends to enjoy the festive season. But before you do, we at ISPE would like to take this opportunity...

Guidance Documents

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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GAMP RDI Good Practice Guide: Data Integrity by Design

GAMP RDI Good Practice Guide: Data Integrity by Design

Published

October 2020

This ISPE GAMP® RDI Good Practice Guide: Data Integrity by Design supports organizations as they embrace and implement a holistic approach by leveraging data governance and knowledge management activities to drive continual improvement in data integrity.

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Guide: Cleaning Validation Lifecycle - Applications, Methods, & Controls

Guide: Cleaning Validation Lifecycle - Applications, Methods, & Controls

Published

August 2020

Thisguide provides a hands-on approach to support the life science industry in the development and establishment of compliant cleaning programs that meet or exceed regulatory expectations.

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Women in Pharma®: Empowering Women as Industry Leaders

Women in Pharma® is a place where women and men—especially those new to the industry—can access a network of mentors, role models, and educational resources to support their professional success. The widespread global interest and...

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Pharmaceutical Engineering January / February 2021 Cover

Nordic Affiliate

Guidance Documents

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

GAMP RDI Good Practice Guide: Data Integrity by Design

GAMP RDI Good Practice Guide: Data Integrity by Design

Guide: Cleaning Validation Lifecycle - Applications, Methods, & Controls

Guide: Cleaning Validation Lifecycle - Applications, Methods, & Controls

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