Roberto Barriga received a BS in computer engineering from Universidad Politecnica de Valencia, Spain, and an MBA from ESADE Business School in Spain. He is...
Rolf Blumenthal is a Senior Consultant at Körber Pharma (formerly Werum) and has many years of experience in the pharmaceutical industry. He joined Werum in...
David Zamora received his PhD in chemistry from the Universitat Autonoma de Barcelona, where he did research in applied chemometrics, process modelling, data analytics, and...
Miguel Romero Obon is an Engineer in chemistry and Statistician by Universitat Politècnica de Catalunya. He is co-director of the Statistics for the Pharmaceutical Industry...
Innovation is an integral part of corporate strategy. Initiatives to facilitate innovation are continually developed and pursued. The 2022 ISPE Pharma 4.0™ Emerging Leader (EL) Hackathon was designed based on innovator needs and provided a hands-on blueprint manufacturing exercise. Over a period of two days and facilitated by 40 subject matter experts, coaches, and jury members, 50...
On 7 March 2023, ISPE continued its tradition of concluding the 2023 ISPE Aseptic Conference with a regulatory panel question and answer session. Attendees were invited to submit questions to the FDA representatives. This article offers highlights from the discussion.
The ICH Quality Discussion Group (QDG) has recommended contemporizing the specification setting guidelines ICH Q6A and Q6B. This provides an excellent opportunity to update ICH Q6A/B to align and work in a complementary manner with the science-, risk/knowledge-based concepts in ICH Q8–Q12. The ISPE Pharmaceutical Quality Lifecycle Implementation (PQLI) Patient-Centric Specification working...