Currently Nordic Affiliate have 400 registered Members with active regional representation in all Nordic countries. The activities consist of both Conferences and Network Meetings.
Currently Nordic Affiliate have 400 registered Members with active regional representation in all Nordic countries. The activities consist of both Conferences and Network Meetings.
ISPE Nordic is currently planning the following events: Computerised Systems Validation – expectations from the authorities – coming in end October The robots are coming...
503B Compounding Pharmacies: Principles, GMPs and Case Studies Extended Learning Learning Level: Advanced Time: 1100 - 1300 ET Session Length: 2 hours In the early 2010s...
This course will explore the essential concepts and principles of specification, design, commissioning/qualification of equipment and systems used to store and distribute...
This course uses the second edition of the ISPE Baseline® Guide: Sterile Product Manufacturing Facilities and the FDA's Guidance for Industry: Sterile Drug Products Produced...
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...
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...
What can the industry do to facilitate remote and distant assessments? Are distant assessments ‘here for now’ or ‘here forever’? Will the future be a ‘Hybrid model’? Will onsite inspections be prioritized once it is safe...
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.
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.
APQ Guide: Corrective Action & Preventive Action (CAPA) System
Published
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.
GAMP RDI Good Practice Guide: Data Integrity by Design
Published
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.
The ISPE Pharma 4.0™ Special Interest Group (SIG) launched in 2015 to provide a road map for new challenges of digitalization, Industry 4.0, and the smart factory. The Special Interest Group addresses how pharmaceutical industry...