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Quality by Design - New Concepts for Chemical and Biotech Product Development and Optimisation

Sep 22 2014 12:30PM - Sep 24 2014 5:00PM | Pharmig Academy Garnisiongasse 4/4 1090 Vienna Austria

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Overview 

In this hands-on course the key elements of Quality by Design for small molecules and biotech products will be discussed. Participants from pharmaceutical, biotech and generic industry as well as regulators will learn, with practical work on case studies (solid dosage form of a small molecule and manufacturing process for a biotech product), how to use Quality Risk Management (QRM), Process Characterisation, Design of Experiments (DoE), Development of a Design Space and Control Strategy, as well as the tools of Knowledge Management (KM).

In the case studies all participants will prioritise the potential critical formulation and process parameters with QRM, propose, execute and evaluate a DoE to define the critical parameters and eliminate uncritical parameters. The knowledge gained will be used to establish a Design Space and essential elements of the control strategy. Knowledge Management will be introduced to keep the information and knowledge gained transparent and available for the full lifecycle of the product. The case study will demonstrate that a systematic approach to pharmaceutical development and optimisation, respectively, will be faster and will lead to robust processes. Potential internal savings and the regulatory flexibility will be discussed with a key European regulator.

The course will also give an overview on global requirements including new relevant EU regulations and discuss opportunities for an optimal QbD submission.

This course has limited capacity. Please register early.

To see the detailed programme, please click on View PDF above.

 

What the participants from previous QbD courses say:

"This training is very good and supportive for my job"

"Interesting to hear how to use QbD in regulatory submission"

"Case studies are good"

What You Will Learn 

  • Quality by Design for biotech products and small molecules
  • Prior Knowledge, Knowledge Management and QTPP Development
  • Initial Risk Assessment (FMEA), Introduction to Process Characterisation and Design of Experiments
  • Experimental Work, Multi-variate Data Analysis (MVA) and Knowledge Space Establishment
  • Design Space Definition
  • Control StrategyTechnologies Assisting QbD Approach
  • Regulatory Flexibility and QbD submission strategies
  • Post-Approval Change Management Protocol

Who Should Attend 

Pharmaceutical scientists, chemist, biologists and engineers. Experts from industry (pharmaceutical companies, biotech companies, generic industry) and regulators with experience in pharmaceutical, chemical and biotech development, manufacturing, quality assurance and CMC.

Learning Objectives 

At the conclusion of this course, participants should be able to:

  • Understand what QbD for biotech and small molecules is
  • Define how critical formulation and process parameters are identified
  • Use Quality Risk Management in the context of QbD
  • Use tools of scientific process characterisation
  • Plan and evaluate basic experimental designs
  • Develop a Design Space
  • Develop a Control Strategy
  • Develop a Knowledge Management structure
  • Understand how to submit QbD data and get regulatory flexibility 

This course is a hands-on course full of practical work. It is necessary that you bring your laptop with you.

Participants will complete a knowledge check at the end of the course and will be provided with feedback to ensure learning objectives are attained.

Hotel & Travel 

The training course will take place at:
Pharmig Academy
Garnisongasse 4/4
1090 Vienna
Austria

E-mail: office@pharmig-academy.at
http://www.pharmig-academy.at/

DIA has blocked a limited number of rooms at the following hotel:

Hotel Regina
Rooseveltplatz 15
1090 Vienna
Austria

Tel.: +43 1 404 46 0
E-mail: regina@kremslehnerhotels.at

at the rate of EUR 110.00 per single room and EUR 130.00 per double room inclusive of VAT, service, taxes, and buffet breakfast.

To reserve a room, please contact the hotel with your credit card details at regina@kremslehnerhotels.at with booking reference “DIA”.

Important: Please complete your reservation by 22 August 2014. Reservations received after this date will be subject to hotel availability and the room rate may vary.

Contact Information 

DIA Europe, Middle East and Africa
Kuechengasse 16
4051 Basel, Switzerland

Registration questions
Contact Center
Tel: +41 61 225 51 51
diaeurope@diaeurope.org

Programme details
Ms Gunta Sveke
Tel: +41 61 225 51 55
gunta.sveke@diaeurope.org

 

Faculty 

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Agenda  

Day 1 Monday, Sep 22, 2014

  • 12:30PM - 1:30PM (Central European Standard Time)

    REGISTRATION
  • 1:30PM - 3:00PM (Central European Standard Time)

    Session 1: INTRODUCTION
  • 3:00PM - 3:30PM (Central European Standard Time)

    COFFEE BREAK
  • 3:30PM - 5:00PM (Central European Standard Time)

    Session 2: PRIOR KNOWLEDGE, KNOWLEDGE MANAGEMENT AND THE QUALITY TARGET PRODUCT PROFILE
  • 5:00PM - 6:00PM (Central European Standard Time)

    DRINKS RECEPTION

Day 2 Tuesday, Sep 23, 2014

  • 9:00AM - 10:30AM (Central European Standard Time)

    Session 3: INITIAL RISK ASSESSMENT (FMEA), INTRODUCTION TO PROCESS CHARACTERISATION AND DESIGN OF EXPERIMENTS
  • 10:30AM - 11:00AM (Central European Standard Time)

    COFFEE BREAK
  • 11:00AM - 12:30PM (Central European Standard Time)

    Session 4: EXPERIMENTAL WORK
  • 12:30PM - 1:30PM (Central European Standard Time)

    LUNCH
  • 1:30PM - 3:00PM (Central European Standard Time)

    Session 5: DATA ANALYSIS AND KNOWLEDGE SPACE ESTABLISHMENT
  • 3:00PM - 3:30PM (Central European Standard Time)

    COFFEE BREAK
  • 3:30PM - 6:00PM (Central European Standard Time)

    Session 6: DISCUSSION OF THE EXPERIMENTAL DESIGN GROUP WORK

Day 3 Wednesday, Sep 24, 2014

  • 9:00AM - 10:30AM (Central European Standard Time)

    Session 7: DESIGN SPACE
  • 10:30AM - 11:00AM (Central European Standard Time)

    COFFEE BREAK
  • 11:00AM - 12:30PM (Central European Standard Time)

    Session 8: CONTROL STRATEGY
  • 12:30PM - 1:30PM (Central European Standard Time)

    LUNCH
  • 1:30PM - 3:00PM (Central European Standard Time)

    Session 9: REGULATORY FLEXIBILITY
  • 3:00PM - 3:30PM (Central European Standard Time)

    COFFEE BREAK
  • 3:30PM - 4:20PM (Central European Standard Time)

    Session 10: SUMMARY AND FINAL DISCUSSION
  • 4:20PM - 5:00PM (Central European Standard Time)

    COURSE ASSESSMENT

Registration Fees 

Member

Charitable Nonprofit/Academia Member
€775.00
Member Government
€775.00
Member Standard
€1550.00

Non-Member

Charitable Nonprofit/Academia Nonmember
€905.00
NonMember Government
€905.00
NonMember Standard
€1680.00
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