Good Manufacturing Practice (GMP)
COURSE DESCRIPTION
The ‘Good Manufacturing Practice (GMP)’ course provides a structured introduction to the principles, regulatory expectations, and operational standards that ensure the safe, consistent, and high‑quality manufacture of products within the pharmaceutical, biotechnology, cosmetics, and food sectors. Designed for students and early‑career professionals in the life sciences, the programme explains how GMP safeguards public health by ensuring that products are manufactured, controlled, and documented in accordance with internationally recognised quality standards.
Participants explore the scientific and regulatory foundations of GMP, including the historical development of quality systems and the emergence of global frameworks such as EU GMP and WHO GMP. The course examines why rigorous manufacturing controls are essential, how contamination risks are prevented, and how quality assurance processes underpin the reliability, safety, and efficacy of finished products. This grounding enables attendees to appreciate the rationale behind GMP requirements and the critical role they play in regulated industries.
A key component of the programme is the study of roles and responsibilities within GMP‑compliant environments. Attendees learn how production teams, quality assurance personnel, quality control laboratories, regulatory authorities, and other stakeholders collaborate to maintain compliance throughout the manufacturing lifecycle. The course highlights how each role contributes to product integrity, documentation accuracy, and adherence to regulatory expectations.
The course also introduces participants to essential GMP documentation and operational processes. Through practical examples, attendees examine the structure and purpose of standard operating procedures, batch manufacturing records, deviation reports, and corrective and preventive action systems. These insights help participants understand how theoretical quality principles are translated into day‑to‑day practice within manufacturing facilities.
By integrating conceptual teaching with applied examples, the programme equips participants with a coherent understanding of how GMP functions and how early‑career professionals contribute to compliant, safe, and efficient manufacturing operations. This foundation supports informed decision‑making for those considering future roles in production, quality assurance, quality control, regulatory affairs, or related areas within the pharmaceutical and broader life science sectors.
ONLINE INSTRUCTOR-LED COURSE
Organizers: Avantyo Institute of Clinical Research
Location: Online
Duration: 1-day session, 8 hours
Training days: September 18, 2026
Training time: From 10 AM GMT+2
Language: English
Trainer: Prof. Univ. Dr. Viorel Robert Ancuceanu
Attendance only by online reservation. Booking available after registering on this site.
COURSE MODULES
The programme is structured into clearly defined modules that guide participants through the scientific, regulatory, and operational principles of Good Manufacturing Practice. Each module builds progressively to ensure a coherent and comprehensive learning experience across all aspects of compliant manufacturing.
- Good Manufacturing Practices: An introduction to the fundamental principles of GMP, including quality systems, regulatory expectations, and the rationale behind controlled manufacturing environments.
- Record Keeping and Documentation: Detailed guidance on documentation standards, batch records, standard operating procedures, deviation reporting, and the importance of traceability and data integrity.
- Personal Protective Equipment: Instruction on the correct selection, use, and maintenance of personal protective equipment to ensure operator safety and prevent product contamination.
- Tools and Equipment: Overview of equipment qualification, calibration, cleaning, and maintenance requirements essential for ensuring consistent and reliable manufacturing operations.
- Raw Materials and Finished Products: Examination of material control processes, including supplier qualification, incoming inspection, storage conditions, and quality testing of finished products.
- Environment and the Facility: Exploration of facility design, environmental monitoring, sanitation practices, and controlled areas that support GMP‑compliant production.
- Safety Audit: Introduction to internal and external audit processes, including preparation, execution, corrective actions, and continuous improvement strategies.
- Summary: Consolidation of key concepts, reinforcing the essential principles and operational expectations of GMP.
- Test: A final assessment to evaluate understanding of the course content and its practical application.
WHY ATTEND OUR GOOD MANUFACTURING PRACTICE (GMP) TRAINING?
Attending our GMP Training course provides essential knowledge for students and early‑career professionals seeking to understand how high‑quality, compliant manufacturing is achieved within regulated industries. Here is why it is a valuable choice:
Clear Understanding of GMP Principles: The course offers a structured introduction to the core concepts of Good Manufacturing Practice, including quality systems, contamination control, and regulatory expectations.
Expert Instruction: Learn from experienced professionals who bring practical insight into GMP‑compliant operations across pharmaceutical, biotechnology, cosmetics, and food manufacturing environments.
Practical, Applied Learning: Engage with real‑world examples that demonstrate how GMP principles are implemented in production facilities, quality control laboratories, and quality assurance departments.
Regulatory Confidence: Gain clarity on the regulatory frameworks that govern GMP, including EU GMP, WHO GMP, and associated inspection expectations.
Quality and Safety Awareness: Strengthen your understanding of contamination prevention, sanitation, environmental monitoring, and equipment control, ensuring safe and compliant manufacturing practices.
Career Development: Build a solid foundation for future roles in production, quality assurance, quality control, regulatory affairs, or other areas within the pharmaceutical and life science sectors.
Enhanced Operational Competence: Improve your ability to interpret GMP documentation, follow standard operating procedures, and contribute effectively to multidisciplinary manufacturing teams.
Preparation for Professional Environments: The course equips you with the terminology, conceptual clarity, and practical awareness required for early‑career positions in GMP‑regulated industries.
For discounts and assistance, or if you wish to be placed on a waiting list for the next course, or require any additional information, please contact us at diana.lupu@avantyo.com (+40 0726 840 456). Be sure to mention your specific educational requirements in clinical trials.
This course is intended for students and early‑career professionals in the life sciences who require a clear, structured introduction to the principles and operational expectations of Good Manufacturing Practice. It is particularly suitable for individuals who wish to understand how regulated manufacturing environments ensure product quality, safety, and consistency across pharmaceutical, biotechnology, cosmetics, and food sectors.
Participants typically include:
- Students and recent graduates in pharmacy, biotechnology, chemistry, biology, biochemistry, or related disciplines who seek an initial understanding of GMP standards and compliant manufacturing processes.
- Individuals exploring career pathways beyond academic or laboratory‑based research and who wish to understand how quality systems support industrial production.
- Early‑career professionals who require clarity on the roles of production teams, quality assurance, quality control, and regulatory oversight within GMP‑regulated facilities.
- Those preparing for entry‑level roles such as production technician, quality assurance assistant, quality control analyst, or junior positions within manufacturing and compliance departments.
The course is designed for participants who may have limited prior exposure to GMP but who are motivated to build a solid conceptual foundation before progressing to more specialised training or applying for roles in regulated industries. It provides the context, terminology, and practical understanding necessary to navigate the early stages of a career in GMP‑compliant manufacturing with confidence.
Robert Ancuceanu “Carol Davila” University of Medicine and Pharmacy, Bucharest, Romania
Professor Robert Ancuceanu is a senior academic within the Bucharest Faculty of Pharmacy at the Carol Davila University of Medicine and Pharmacy, where he teaches Cell and Molecular Biology and Pharmaceutical Botany, and is currently a Vice-dean. He holds a PhD in Pharmacy, a Master’s degree in Biostatistics, and a Bachelor’s degree in Law, and has worked across multiple pharmaceutical domains, ranging from academia to industry and regulatory affairs.
He served as Director General of the General Directorate for Pharmaceutics and Medical Devices within the Romanian Ministry of Health and as Vice-president of the Romanian National Medicines Agency. He was a member of the EMA Committee for Human Medicinal Products (CHMP), the Paediatric Committee (PDCO), and an alternate member of the Committee on Herbal Medicinal Products (HMPC), as well as a participant in several national committees and working groups in the pharmaceutical field.
He is a Steering Group member of the TOPRA Product Information and Labelling SPIN. Professor Ancuceanu has published over 100 scientific papers, including 85 indexed in ISI Clarivate, has authored two books, and has contributed as co-author or chapter author to fourteen further volumes.
He is deeply engaged in the application of computational methods within the life sciences, with interests spanning chemoinformatics, bioinformatics, computational biology, and biostatistics. His current H-index is 22, with more than 7,600 citations.
Beyond his broad engagement with the pharmaceutical sciences, Professor Ancuceanu describes himself as a late Renaissance man, with additional interests in law, history, music, programming and computer science, sociology, art, and literature.
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