Postgraduate in Pharmaceutical Plant Engineering

Program Overview

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The Postgraduate in Pharmaceutical Plant Engineering at IQS Barcelona equips professionals with advanced technical knowledge in pharmaceutical and biopharmaceutical plant design and management. Through practical application, expert faculty, and networking opportunities, graduates enhance their industry expertise and gain leadership roles in the booming biopharmaceutical sector, both nationally and internationally.

Program Outline

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Degree Overview:

The Postgraduate in Pharmaceutical Plant Engineering at IQS, located in Barcelona, is designed for young professionals seeking to enter the pharmaceutical industry and experienced professionals interested in enhancing their technical knowledge in the improvement or construction of pharmaceutical plants. The program addresses the growing market for biopharmaceutical products, which necessitates changes in manufacturing processes, transitioning from traditional chemical synthesis to genetic manipulation of living organisms. The biopharmaceutical industry is undergoing rapid transformation to achieve more efficient processes that ensure product quality. This program aims to equip professionals with the necessary skills and knowledge to design and manage new biopharmaceutical manufacturing processes. The industry demands professionals with expertise in engineering, data analysis, and process development, as current talent pools are insufficient to meet the growing needs. IQS's commitment to society and industry drives the development of this program, fostering the growth of top professionals in the biopharmaceutical industry and creating attractive international career opportunities.

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Key Features:

• Start Date: 17/1/2025
• End Date: 28/06/2025
• Duration: 6 months
• Mode: In-person
• Credits: 29 ECTS
• Hours: 159
• Price: 7.300€
• City: Barcelona

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Program Highlights:

• Offers advanced technical knowledge in pharmaceutical plants.
• Serves as a gateway to the pharmaceutical and biopharmaceutical industries.
• In-person format facilitates interaction between participants and faculty.
• Practical and real-world orientation, mirroring current plant operations.
• Backed by the prestige and rigor of an IQS qualification.

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Outline:

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Program Structure:

The program targets two distinct profiles:

• Young professionals seeking to enter the pharmaceutical sector, including laboratories with operational plants, machinery manufacturers, engineering firms, and installers, to lead or participate in projects involving plant expansion, improvement, or construction.
• Professionals with experience in the pharmaceutical industry interested in enhancing their technical knowledge applied to the design of bio/pharmaceutical production plants for human and veterinary medicines.

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Learning Methodology:

The program emphasizes practical application, aiming to directly impact participants' professional lives.

• Project-Based Learning: Participants will develop a project during the program, working on a valuable initiative for their company.
This project serves two objectives:
• To apply classroom learning to real-world scenarios.
• To demonstrate the return on investment for the company in the participant's development.
• Interactive Sessions: Various dynamics will be employed throughout the program to foster a practical, effective, and stimulating learning process.

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Program Content:

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Regulatory Framework and Permits for Plant Design:

• Description:
This module establishes guidelines based on European and North American (FDA) GMP pharmaceutical regulations. Participants will understand the process of obtaining authorization for new pharmaceutical facilities.

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Fundamentals of Pharmaceutical and Biopharmaceutical Plants:

• Description:
This module connects GMP concepts with the production plant, defining aspects such as facility zones, personnel and material flows, and the basics of biotechnology applied to the pharmaceutical sector. It includes a description of the main therapeutic biological molecules.
• Topics:
• Plants for the production of therapeutic molecules through bioprocesses.
• Plants for injectable and solid oral medications.
• Topics:
• ASME BPE and DIN standards for materials in pharmaceutical facilities and pressure equipment.
• Compounding and transfer systems in liquid manufacturing.
• Valving for fluid processes and pharmaceutical equipment.
• Sizing of pharmaceutical equipment and instrumentation for measurement and control.
• Plants for generating compendial waters (PW, WFI, PS).
• ISPE and PW, WFI, PS systems.
• Compressed air supply and treatment in pharmaceutical facilities.
• Compressor technology, rooms, and compressed air distribution networks.
• Nitrogen generation facilities, "in situ" and external.
• Air filtration mechanisms, dust capture, and containment systems.
• HVAC air systems for clean rooms and aseptic environments.
• Electromechanical installations and general services.

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Production Lines, Machinery, and Auxiliary Equipment:

• Description:
This module focuses on the design and optimization of industrial production lines for the development and production of pharmaceutical specialties in solid, liquid, and therapeutic biomolecule forms.
• Topics:
• Manufacturing and machinery for solid dosage forms.
• Manufacturing and machinery for liquid dosage forms.
• "Single-use" systems for formulation, filling, and purification of biological products.
It covers concepts and topics such as time, cost, and resource management, methodologies, technical report preparation, construction permits, and written and oral project presentations.

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Quality Assurance Strategies and Systems:

• Description:
This module describes the strategies and fundamentals of CQV (Commissioning, Qualification, and Validation) applicable to facilities, equipment, and services. It explains the reasons and importance of the Master Validation Plan (MVP) and User Requirement Specification (URS). It presents a risk management approach for quality throughout the entire lifecycle of a drug.
• Topics:
• Risk management for quality.
• Justification and documentation of risk assessments for facilities, equipment, and services.

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Commissioning, Qualification, and Validation:

• Description:
This module emphasizes the importance of proper commissioning and the preparation of protocols and execution. It reviews the required tests and common challenges encountered during the qualification of facilities, services, equipment, and computerized systems.
• Topics:
• Commissioning/start-up.
• Qualification and validation of equipment, facilities, and services.
• Process validation and cleaning design according to FDA and EU-GMP.
• Calibration and maintenance of analytical instrumentation.
• Quality by Design and PAT.

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Smart Manufacturing and Digital Transformation:

• Description:
This module provides an overview of automation strategies in the pharmaceutical sector and the implications of a Pharma 4.0 environment in terms of available technologies. It addresses the development of a digital transformation roadmap in a regulated environment like the biopharmaceutical industry.
• Topics:
• Automation and control in an Industry 4.0 environment.
• Topics:
• Management and operation of a pharmaceutical plant.

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Teaching:

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Faculty:

The program boasts a faculty of specialists in their respective fields, known for their expertise and close relationships with participants, commitment to their learning, and generosity in sharing knowledge.

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Teaching Methods:

• Practical Application: The program emphasizes hands-on learning through projects and interactive sessions.
• Expert Faculty: Participants benefit from the expertise and experience of industry professionals.
• Networking Opportunities: The in-person format fosters connections between participants and faculty.

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Careers:

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Career Paths:

• Pharmaceutical Industry: Graduates can pursue roles in laboratories with operational plants, machinery manufacturers, engineering firms, and installers, leading or participating in projects involving plant expansion, improvement, or construction.
• Biopharmaceutical Industry: Graduates can specialize in the design and management of bio/pharmaceutical production plants for human and veterinary medicines.

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Opportunities:

• International Career Opportunities: The program prepares graduates for global career opportunities in the pharmaceutical and biopharmaceutical industries.
• Leadership Roles: Graduates are equipped to take on leadership positions in project management, plant design, and operations.

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Outcomes:

• Enhanced Technical Skills: Graduates gain advanced technical knowledge in pharmaceutical plant engineering.
• Industry Expertise: The program provides a comprehensive understanding of the pharmaceutical and biopharmaceutical industries.
• Networking Opportunities: Graduates build valuable connections with industry professionals and faculty.

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Other:

• Admission Process: The admission process involves an interview to assess the candidate's professional background, experience, motivation, and commitment to the program.
• Title: Graduates can obtain the "Experto Universitario en Ingeniería de Plantas Farmacéuticas" title from the Ramon Llull University (URL) upon completion of the program and successful defense of a project.