Introduction

Pharmaceutical Process Engineering is a critical discipline that integrates engineering principles with pharmaceutical manufacturing to ensure safe, scalable, compliant, and cost-effective drug production. With increasing global demand for GMP-compliant manufacturing, continuous processing, process validation, and quality by design (QbD), professionals must be equipped with advanced technical and regulatory expertise. Pharmaceutical Process Engineering Training Course is designed to bridge the gap between theoretical engineering knowledge and real-world pharmaceutical production systems, enabling participants to master modern pharma manufacturing technologies, process optimization, and regulatory compliance frameworks.

The course delivers a comprehensive understanding of API manufacturing, formulation engineering, bioprocessing, process scale-up, validation protocols, and advanced automation systems used in pharmaceutical plants. It emphasizes hands-on learning, industry case applications, and data-driven decision-making aligned with Industry 4.0, smart manufacturing, PAT (Process Analytical Technology), and lean pharmaceutical operations. Participants will gain the ability to design, troubleshoot, and optimize pharmaceutical processes while ensuring adherence to global quality and safety standards.

Programme Curriculum

Pharmaceutical Process Engineering Training Course

Introduction

Course Duration

5 days

Course Objectives

Master Pharmaceutical Process Engineering principles and industrial applications
Understand GMP, cGMP, FDA, EMA regulatory compliance systems
Apply Quality by Design (QbD) in drug manufacturing processes
Learn API manufacturing and formulation development techniques
Implement Process Analytical Technology (PAT) in real-time monitoring
Optimize pharmaceutical plant design and layout engineering
Develop expertise in process scale-up and tech transfer strategies
Improve biopharmaceutical production and bioprocess engineering workflows
Strengthen validation protocols: IQ, OQ, PQ in pharma systems
Utilize Lean Manufacturing and Six Sigma in pharma production
Enhance process automation and Industry 4.0 integration
Control contamination, sterility assurance, and aseptic processing systems
Achieve cost optimization and operational excellence in pharma plants

Target Audience

Pharmaceutical Engineers
Chemical Engineers in Pharma Industry
QA/QC Professionals
Production and Manufacturing Managers
Biotechnology Professionals
Regulatory Affairs Specialists
Fresh Graduates in Pharmacy / Chemical Engineering
R&D Scientists and Process Development Experts

Course Modules

Module 1: Fundamentals of Pharmaceutical Process Engineering

Basics of unit operations in pharma
Drug development lifecycle overview
Material and energy balance in pharma processes
Pharmaceutical raw materials classification
Introduction to GMP systems
Case Study: Failure analysis in tablet production batch inconsistency

Module 2: API Manufacturing & Chemical Process Design

Active Pharmaceutical Ingredient (API) synthesis
Reactor design and optimization
Catalysis and reaction engineering
Solvent selection and recovery
Process safety in API plants
Case Study: Optimization of paracetamol API synthesis yield improvement

Module 3: Pharmaceutical Formulation Engineering

Solid, liquid, and semi-solid formulations
Tablet compression and capsule filling processes
Excipient functionality and selection
Stability and compatibility studies
Controlled release formulation design
Case Study: Extended-release tablet formulation failure investigation

Module 4: Bioprocess Engineering & Biopharmaceuticals

Fermentation technology and bioreactors
Cell culture systems
Downstream processing techniques
Protein purification methods
Biosimilars production process
Case Study: Monoclonal antibody production scale-up challenge

Module 5: Process Validation & Quality Assurance

IQ, OQ, PQ validation lifecycle
Cleaning validation strategies
Process validation protocols
Deviations and CAPA management
GMP documentation systems
Case Study: Regulatory audit failure due to incomplete validation records

Module 6: Process Scale-Up & Technology Transfer

Lab to plant scale-up strategies
Pilot plant operations
Tech transfer documentation
Risk assessment tools
Process reproducibility control
Case Study: Scale-up failure in antibiotic production batch transition

Module 7: Automation, PAT & Industry 4.0 in Pharma

Process Analytical Technology (PAT) tools
SCADA and DCS systems in pharma
Real-time process monitoring
AI and data analytics in manufacturing
Smart factory integration
Case Study: AI-based predictive failure prevention in tablet coating process

Module 8: Lean Manufacturing & Continuous Improvement

Lean Six Sigma in pharmaceutical production
Waste reduction strategies
Process optimization tools
Energy efficiency in pharma plants
Continuous manufacturing systems
Case Study: Cost reduction in sterile injectable manufacturing line

Training Methodology

This course employs a participatory and hands-on approach to ensure practical learning, including:

Interactive lectures and presentations.
Group discussions and brainstorming sessions.
Hands-on exercises using real-world datasets.
Role-playing and scenario-based simulations.
Analysis of case studies to bridge theory and practice.
Peer-to-peer learning and networking.
Expert-led Q&A sessions.
Continuous feedback and personalized guidance.

Register as a group from 3 participants for a Discount

Send us an email: info@fineskilltrainingcenter.org or call +254769199797

Certification

Upon successful completion of this training, participants will be issued with a globally- recognized certificate.

Tailor-Made Course

We also offer tailor-made courses based on your needs.

Key Notes

a. The participant must be conversant with English.

b. Upon completion of training the participant will be issued with an Authorized Training Certificate

c. Course duration is flexible and the contents can be modified to fit any number of days.

d. The course fee includes facilitation training materials, 2 coffee breaks, buffet lunch and A Certificate upon successful completion of Training.

e. One-year post-training support Consultation and Coaching provided after the course.

f. Payment should be done at least a week before commence of the training, to Fineskill Training Center account, as indicated in the invoice so as to enable us prepare better for you.

Skills & Software Covered

Process scale-up GMP manufacturing Purification systems Quality control

Programme Fee

Duration: 5 Days

Method: Online or Physical

Online Price: $1,000

Physical Price: $1,500

Certification: Accredited Certificate

View Available Dates 📄 Download Course Outline (PDF)

Available Sessions

Location

Month

Year

Sep 21 2026

21 Sep — 25 Sep 2026

💻 Online / Virtual session

Online $1,000