Practical Approaches to Quality and Development by Design for Robust Chemical Processes

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

Date: 09 April - 11 April 2019

Location: Der Teufelhof, Basel

Tutors: Dr Andrei Zlota

Save €480 with our Early bird rate – Book before January 15th 2019

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

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

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Course Outline

Introduction

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

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

Hands-on Workshops

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