EMAIL Print

Training Courses

Event 

Title:
Practical Approaches to Quality by Design for Pharmaceutical Process R&D and Manufacturing
Subtitle:
A 3 day course presented by Dr Andrei Zlota of the ZLOTA Company LLC In conjunction with Scientific Update LLP
When:
10.06.2014 - 12.06.2014
Tutors:
Where:
Renaissance Seattle Hotel - Seattle
Brochure:
View Brochure

Description

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

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

  • Introduction

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

    Development and Production Chemists

    Chemical Engineers and Analysts

  • To view this video, click the video and wait a short time whilst the video loads, it will then start to play.

  • "This was a very good course. Dr Zlota is very knowledgeable and communicated very well"

    "I will recommend this course to my colleagues."

    "Andrei is a great presenter, very knowledgeable, and talented."

    "I was very impressed with the diversitt of topics covered, and Andrei's mastery of multiple disciplines."

    "Very inspiring course"

    "I found the course extremely intersting, clear, interactive and followable thanks to the professionalism of the excellent lecturer. Thanks a lot"

    "Great Course covering many of today's hot topics. The range was good and some areas were necessarily condensed, however this meant the key messages were powerfully delivered."

    "The course provided a comprehensive overview of QbD and more importantly where to begin implementing it."

download the video fileDownload this short presentation from Andrei to hear what you will learn on this course.

Fee Info

Course Fee:
$2200
Multi Discount:
SAVE 5% for 2 attendees and 15% for 3 attendees

Venue

Renaissance Seattle HotelMap
Venue:
Renaissance Seattle Hotel   -   Website
Street:
515 Madison Street
Postcode / ZIP:
98104
City:
Seattle
State:
WA
Country:
Country: us

Description

The Renaissance Seattle Hotel is located in downtown Seattle and situated just 20 minutes from Seattle-Tacoma Airport.

 Relax in newly renovated, spacious guest rooms that feature stunning views of Puget Sound, the mountains and city skyline. Enjoy the fully-equipped fitness center and high-speed Internet access.