New Jersey ISPE is an organization of, and for, professionals in the ever changing Life Sciences Community. As such, we strive to provide value to our various constituencies – owners, consultants, designers, contractors, vendors, students and the un- and under-employed.
New Jersey ISPE is an organization of, and for, professionals in the ever changing Life Sciences Community. As such, we strive to provide value to our various constituencies – owners, consultants, designers, contractors, vendors, students and the un- and under-employed.
Robotic process automation (RPA) software automatically handles manual, repetitive, time-consuming, and highly structured tasks such as data entry and back-office functions...
Featured in this edition of the Pharmaceutical Engineering Online Reading Roundup are the most read online articles during March 2021. Learn more about understanding...
ISPE will convene regulators, auditors, remote auditors, and inspectors representing 11 regulatory agencies from around the world at the 2021 ISPE Global Pharmaceutical...
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...
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...
Thank You for Making this Conference a Huge Success! The ISPE Aseptic Conference has been setting the pace for the evolution of sterile manufacturing processes and technologies in the pharmaceutical industry for 30 years...
International Women's Day (March 8) is a global day celebrating women's social, economic, cultural, and political achievements. The theme for International Women’s Day 2021 is Choose to Challenge. It’s a clear call to...
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...