Introduction

Chemical Process Development and Scale-Up is a critical discipline in modern pharmaceutical manufacturing, fine chemicals, biotechnology, and industrial chemical engineering, ensuring seamless transition from laboratory innovation to full-scale commercial production. This training course provides a deep dive into Process Design, Optimization, Scale-Up Strategies, Quality by Design (QbD), Process Analytical Technology (PAT), GMP compliance, and tech transfer protocols. Participants will gain practical expertise in transforming bench-scale reactions into robust, cost-effective, and regulatory-compliant industrial processes while minimizing risk, improving yield, and ensuring product quality consistency.

In today’s competitive and highly regulated environment, organizations demand professionals skilled in advanced chemical engineering principles, process intensification, digital manufacturing, continuous processing, and lifecycle process validation. Chemical Process Development and Scale-Up Training Course bridges the gap between R&D and manufacturing by equipping learners with industry-relevant competencies in scale-up modeling, reactor design, process safety, kinetic studies, and regulatory documentation. Through real-world case studies and hands-on simulations, participants will master the art and science of delivering scalable, sustainable, and economically viable chemical processes.

Programme Curriculum

Chemical Process Development and Scale-Up Training Course

Introduction

Course Duration

5 days

Course Objectives

Master Chemical Process Development Lifecycle (CPLD) from lab to plant scale
Apply Quality by Design (QbD) principles in process optimization
Understand Process Scale-Up & Scale-Down methodologies
Design and evaluate chemical reactors for industrial production
Implement Process Analytical Technology (PAT) for real-time monitoring
Conduct reaction kinetics and thermodynamics analysis
Ensure GMP & regulatory compliance
Develop robust tech transfer protocols and documentation
Apply process intensification and continuous manufacturing concepts
Perform risk assessment using HAZOP and FMEA tools
Optimize yield, selectivity, and process efficiency
Integrate digital process simulation and modeling tools
Execute industrial case-based scale-up troubleshooting strategies

Target Audience

Chemical Engineers in manufacturing and R&D
Pharmaceutical Scientists and Process Chemists
Biotechnology and Bioprocess Engineers
Quality Assurance and Validation Specialists
Production and Plant Managers
Regulatory Affairs Professionals
Industrial Research Scientists
Graduate students in Chemical / Biochemical Engineering

Course Modules

Module 1: Fundamentals of Chemical Process Development

Process lifecycle from discovery to commercialization
Unit operations and process flow design
Reaction engineering basics
Laboratory vs industrial scale differences
Material and energy balance fundamentals
Case Study: Scale-up of aspirin synthesis from lab to pilot plant

Module 2: Reaction Kinetics & Thermodynamic Modeling

Rate laws and reaction mechanisms
Temperature and pressure effects on yield
Equilibrium limitations in industrial processes
Catalyst selection and optimization
Data-driven kinetic modelling
Case Study: Optimization of ammonia synthesis process

Module 3: Scale-Up and Scale-Down Strategies

Geometric, dynamic, and kinematic similarity
Scale-up parameters and constraints
Mixing, heat transfer, and mass transfer effects
Pilot plant design considerations
Scale-down models for troubleshooting
Case Study: API crystallization scale-up failure analysis

Module 4: Process Analytical Technology (PAT) & Control

Real-time monitoring techniques
Spectroscopic and sensor-based PAT tools
Feedback and feedforward control systems
Data acquisition and process automation
Digital twin concepts
Case Study: Real-time monitoring in continuous fermentation

Module 5: Quality by Design (QbD) & Regulatory Compliance

Critical Quality Attributes (CQA)
Design of Experiments (DoE)
Risk-based process design
ICH Q8, Q9, Q10 guidelines
Validation lifecycle approach
Case Study: QbD implementation in tablet manufacturing process

Module 6: Process Safety & Risk Management

HAZOP and FMEA methodologies
Thermal runaway and explosion risks
Chemical compatibility analysis
Safety instrumentation systems
Industrial incident case reviews
Case Study: Industrial reactor explosion root cause analysis

Module 7: Tech Transfer & Industrial Scale Manufacturing

Documentation for technology transfer
Pilot plant to commercial plant transition
Cross-functional team coordination
Manufacturing process validation
Cost optimization strategies
Case Study: Tech transfer of antibiotic production process

Module 8: Process Intensification & Continuous Manufacturing

Batch vs continuous processing
Microreactors and flow chemistry
Energy-efficient process design
Green chemistry integration
Sustainability and waste minimization
Case Study: Continuous flow synthesis of fine chemicals

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

Laboratory development Pilot plant scaling Process optimization Industrial implementation

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