Archived: Practical Approaches to Quality by Design for Pharmaceutical Process R&D and Manufacturing

A 3 day course presented by Dr Andrei Zlota of the ZLOTA Company LLC In conjunction with Scientific Update LTD

Date: 04 April - 06 April 2017

Location: Verona, Italy

Tutors: Dr Andrei Zlota

QbD is no longer a regulatory initiative; because QbD is good development, QbD is an industry initiative supported by regulators.

This course focuses on practical approaches to accelerated QbD implementation, and it makes practical recommendations for realistic implementation of QbD elements.

Participants will learn how to prioritize process parameters for screening designs, how to design robust processes using statistical design of experiments (DoE), how to bridge the bench and the commercial design spaces using mixing and scale-up calculations, how to quantify process risk, how to select suitable process analytical technology tools (PAT) and more.

Effective technology transfer to pilot and manufacturing plants is also discussed, including process validation in the QbD.

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Course Outline


  • Course objectives
  • QbD in the context of the ICH guidelines for pharmaceutical manufacturing industry in the 21st century
  • Overview and definitions; how new is the QbD concept?
  • Current status of QbD implementation

ICH Guidelines

  • Risk-based, modern pharmaceutical manufacturing
  • Brief review of ICH Q8, ICH Q9, ICH Q10 and ICH Q11
  • ICH guidance covering questions and answers on Q8, Q9 and Q10 (2011)

QbD Methodology

  • The evolution of process understanding
  • Target Quality Profile, Critical Quality Attributes
  • Process parameters ranking methods

Screening the Experimental Space

  • Advantages of design of experiments (DoE) vs. one factor at a time approaches
  • The importance of pre-DoE experimentation and planning
  • Factors, ranges, number of le vels, responses
  • Design quality: resolution and efficiency
  • Commercial DoE software (sometimes a second opinion can be useful)

Robust Process Design

  • Key and Critical Process Parameters
  • Response surface methodology, process optimization (at small or intermediate scale) to define a design space
  • Strategies in defining a design space
  • Process validation in the QbD paradigm
  • Control strategy
Risk Analysis

  • Semi-quantitative risk estimates
  • Process risk quantification using Monte Carlo simulations

Pharmaceutical Process Scale-Up

  • Design space and scale-up factors
  • Scale-up theory; scaling-up by scaling-down
  • Mixing and scale-up calculations in turbulent regime, mixing times calculations (micromixing, mesomixing, and macromixing)
  • Effective scale-up of heterogeneous solid-liquid processes (catalytic, API crystallization process scale-up)
  • Process understanding for effective technology transfer
  • Advantages and challenges of continuous chemical processing

Process Analytical Technology

  • PAT principles, levels of PAT implementation
  • Control strategies
  • Real time release

Regulatory Advantages

  • QbD submissions
  • FDA and EMEA QbD pilot programs
  • Learning from QbD “pioneers”
  • QbD Elements

Hands-on Workshops

  • Crystallization process, screening the experimental space
  • Successful scale-up of a fast reaction system
  • ICH Q11 example 10.1
  • QbD HPLC method development

Benefits of attending

  • Prioritize process parameters prior to screening investigations
  • Design effective DoE screening matrixes
  • Design robust processes and assess key and critical process parameters
  • Execute key mixing and scale-up calculations to bridge the bench and the commercial design spaces
  • Use an equipment data base for effective technology transfer to pilot and manufacturing plants, and CMO’s
  • Estimate process risk
  • Make strategic decisions on PAT implementation

Who Should Attend

Organic Chemists – working in the pharmaceutical, pigment, agrochemical, explosives or fine chemicals industries

Development and Production Chemists

Chemical Engineers and Analysts

What's included?

The course fee includes:

  • comprehensive course manual
  • coffee/tea refreshments breaks throughout each day
  • buffet lunch each day
  • course dinner on the first evening
  • course certificate