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Schedule Your Coaching SessionAbout Alireza
Alireza Zarei is the Founder of Pharmuni and CEO of Zamann Pharma Support GmbH, bringing extensive hands-on experience in pharmaceutical quality management, GMP compliance, validation, and digital transformation. Since 2017, he has led Zamann Pharma Support, supporting pharmaceutical and medical-technology organizations with quality systems, regulatory compliance, computerized systems, and innovative digital solutions.
Throughout his career, Alireza has worked on international projects for major life-science organizations including Takeda, BioNTech, Boehringer Ingelheim, Fresenius Medical Care, and Roche. His work has ranged from laboratory quality control and pharmaceutical investigations to global Computer System Validation (CSV), LIMS implementation, data integrity, audit readiness, organizational change management, and quality-system harmonization. At Takeda, for example, he led validation activities for a LabWare LIMS implementation, including interfaces, migration planning, Annex 11 compliance, and laboratory readiness. At BioNTech, his responsibilities included global LIMS deployment, computerized-system assessments, GMP quality-process harmonization, validation documentation, and digital Quality Unit implementation.
His professional background also combines quality management with learning and digital innovation. He has developed global learning and training concepts, including a Learning Management System approach supporting more than 40,000 end users, and has led global validation, TrackWise, environmental-monitoring, and change-management initiatives.
Core areas of expertise include:
- Quality Management and GMP Compliance
- Digital Transformation in Pharmaceutical Operations
- Computer System Validation (CSV) and GAMP 5
- Laboratory Information Management Systems (LIMS)
- eQMS, Data Integrity, and computerized-system compliance
- Learning Management Systems and professional training
- CAPA, deviations, investigations, and risk management
Alireza is also a Certified Quality Management Officer and has specialist knowledge across pharmaceutical quality assurance, FDA and EMA expectations, laboratory technologies, TrackWise, LabWare, and digital quality systems.
Through Pharmuni, he combines this industry experience with a focus on making practical pharmaceutical knowledge, GMP training, and career development more accessible to professionals entering or progressing within the life-sciences industry.
Courses by Alireza
4.8
140 participants
Risk Management Planning in Pharmacovigilance
Master advanced Risk Management Planning in Pharmacovigilance to design, implement, and evaluate inspection-ready RMPs that meet EMA, ICH, and global regulatory requirements.
4.5
135 participants
Aggregate Report Writing in Pharmacovigilance
An advanced course on creating inspection-ready aggregate reports (PSUR, PBRER, DSUR) that meet EMA, FDA, and PMDA requirements through robust planning, quality control, and regulatory response strategies.
5
64 participants
EU Medical Device Regulation
Master EU Medical Device Regulation (MDR) fundamentals: classification, conformity routes, GSPRs, economic actors and post-market duties. This is a concise, case-driven online course with certification.
4.71
269 participants
Pharmacovigilance System
Learn about the Pharmacovigilance System, including identifying safety information, understanding safety databases, and key PV processes and roles to ensure drug safety.
5
86 participants
Post Market Surveillance for Batch Management
Ensure pharmaceutical product safety and efficacy with our course on post-market surveillance, covering pharmacovigilance, stability studies, and quality data management. Ideal for life science professionals.
5
84 participants
Storage and Transport for Production Batch Management
Learn to manage pharmaceutical storage and shipping effectively, ensuring optimal conditions, regulatory compliance, and product integrity in our comprehensive e-learning course.
5
87 participants
Release Phase for Batch Management
Master the essentials of pharmaceutical batch release, focusing on quality assurance, regulatory compliance, and the role of the Qualified Person (QP).
5
99 participants
Execution Phase of Production Batch Management
Explore the execution phase in pharmaceutical manufacturing with our comprehensive online course, covering everything from planning alignment to in-process control.
5
101 participants
Planning Phase for Production Batch Management
Master pharmaceutical production planning with our "Batch Management - Planning Phase" course, ensuring patient safety and efficient supply chain management.
4.55
11194 participants
Introduction to GMP Annex 1
Gain expertise in sterile manufacturing with our GMP Annex 1 course, crafted in collaboration with Hochschule Albstadt-Sigmaringen for aspiring and transitioning professionals.
5
138 participants
Preparing for GMP Audits
Master audit readiness in Pharma and MedTech with our course on effective Audit Management, ensuring compliance and quality in GMP-regulated environments.
5
123 participants
GMP Master Data Management
Learn about different master data types and applications, as well as their impact on organizational success.
5
133 participants
Introduction to Production Batch Management
Master the batch management lifecycle in Pharma, from planning to surveillance. This course focuses on traceability, quality, and safety in drug production.
4.71
237 participants
Introduction to Computer Systems Validation (CSV)
Gain expertise in Computer System Validation with a focus on GAMP®5. This course provides essential insights into software lifecycle and validation, perfect for life sciences professionals new to CSV.
4.67
230 participants
GMP Complaint Management
Master GMP Complaint Management for patient safety, product quality, and regulatory compliance, with real-world case studies and essential quality management strategies.
4.67
228 participants
GMP Supplier Management
Navigate the complexities of supplier qualification in pharma with key insights into audits, agreements, and compliance in our expert-led course.
4.75
232 participants
Introduction to GMP Equipment Qualification
Learn the essential stages of GMP Equipment Qualification, including DQ, IQ, OQ, PQ, and the importance of regulatory compliance and Good Documentation Practices.
4.85
355 participants
GMP Risk Management Principles
Gain expertise in risk management for the pharma industry, mastering strategies to identify, assess, and mitigate risks.
3.8
220 participants
GMP Incident Management
Gain expertise in Incident Management within pharmaceuticals. Navigate incidents effectively in GMP environments for quality assurance and regulatory compliance.
4.27
761 participants
GMP Change Control Management
Master Change Control in GMP environments with our course, focusing on risk management, team collaboration, and maintaining pharmaceutical quality standards.
4.42
30016 participants
Introduction to Pharmacovigilance
Learn pharmacovigilance online. Build practical skills in drug safety, reporting, and compliance with EMA, FDA, ICH, and WHO frameworks. Start your certification today.
5
149 participants
Employee Data Security Basics
Secure pharmaceutical data with advanced strategies in Smart Data Security, essential for today's digital and compliance-driven landscape
4.7
364 participants
GMP Authority Inspections Basics
An introduction to the audit process, feedback loops, behaviours and warnings along with consequences of audit failures.
4.57
26181 participants
Introduction to Good Manufacturing Practices (GMP)
Introduction to GMP provides a clear foundation in Good Manufacturing Practice, covering core principles, daily application, and risk-based thinking in regulated environments.
4.83
512 participants
Introduction to Good Documentation Practices (GDocP)
Master Good Documentation Practices in pharma and life sciences. Ensure quality, compliance, and traceability with effective documentation strategies.
4.29
1030 participants
Introduction to GMP Quality Management Systems
Master the essentials of Quality Management Systems in pharma, focusing on implementation, compliance, and continual improvement.
4.62
426 participants
GMP Corrective and Preventive Actions (CAPA) Management
Master CAPA essentials in Pharma, ensuring product quality and compliance with a deep dive into corrective and preventive action processes.
4.75
404 participants
GMP Deviation Management
Master Deviation Management in GxP environments with our course. Learn to identify, manage, and resolve deviations for product quality and compliance.
4.67
509 participants
Introduction to Life Science Compliance
Master Compliance in Pharma: Understand FDA/EMA standards, tackle complex issues, and excel in maintaining industry regulations effectively."