Back

Zahra HALVORSEN

Compliance Consultant

Biography: Dr. Zahra Halvorsen, a multidisciplinary engineer and consultant, brings extensive hands-on experience within the pharmaceutical industry, with a core focus on GMP compliance, Annex 1 alignment, and regulatory-driven qualification activities. She has led critical Performance Qualification (PQ) efforts for mRNA vaccine production lines, developed and executed qualification protocols for sterile manufacturing environments, and supported regulatory remediation projects addressing inspection findings from authorities such as Swissmedic. Her work encompasses Annex 1 gap assessments, aseptic process optimization, and the implementation of robust contamination control strategies in GMP-regulated facilities. she has contributed to MedTech innovation by developing spectroscopy-based systems and flow cytometry pipelines for contamination detection—applying scientific precision to meet stringent compliance standards. Whether drafting SOPs, coordinating validation teams, or ensuring inspection readiness, she operates at the intersection of regulatory compliance, technical excellence, and operational execution. With a proven track record of supporting global pharmaceutical and medical device companies, she is passionate about enabling safe, efficient, and compliant healthcare solutions through smart engineering and quality-driven practices.

Educational How to manage the revision of cGMPs Annex 01 for sterile products

06/04/2025 | 14:00 - 14:15 | TPD Room

Panel Discussion How to manage the revision of cGMPs Annex 01 for sterile products

06/04/2025 | 14:15 - 14:30 | TPD Room