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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:
24.04.2012 - 26.04.2012
Tutors:
Where:
Sheraton Sand Key Resort - Clearwater Beach
Brochure:
View Brochure

Description

Attaining the “desired state” requires effective Quality by Design (QbD) implementation. 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. For the benefit of process scientists, engineers, formulators, analytical chemists and manufacturing personnel, this course includes highly interactive, hands-on workshops, based on several case studies. Effective technology transfer to pilot and manufacturing plants is also discussed, including process validation in the QbD paradigm.

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

  • Course Outline
  • What you will learn
  • Who Should Attend?
  • Video Taster
  • Customers Say

  • 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 ery 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."

Fee Info

Course Fee:
$1850
Multi Discount:
SAVE 5% for 2 attendees and 15% for 3 attendees

Venue

Sheraton Sand Key ResortMap
Venue:
Sheraton Sand Key Resort   -   Website
Street:
1160 Gulf Boulevard
Postcode / ZIP:
33767
City:
Clearwater Beach
State:
Florida
Country:
Country: us

Description

Situated on the Florida Keys with its own private beach and across the road from the shops of Sand Key, the Sand Keys Resort is in an ideal location for a business meeting, combined with excellent facilities for relaxation afterwards. The hotel has a fully equipped business centre, plus a variety of dining facilities. It has a state-of-the-art health club, plus outdoor recreational pursuits.

The hotel is holding standard rooms for us at a discounted rate. Scientific Update is contractually obligated to certain financial goals with the hotel.  Your reservation is greatly appreciated, as it helps to meet our agreement.  Please make your reservation soon in order to secure the reduced group rate.

Directions:

The hotel is easily accessible from Tampa or Orlando International Airports.
Shuttle services are available from the airports to the hotel.