SPEAKERS:

Dr Joachim ErmerSanofi, Germany

Patrick JacksonGSK, United Kingdom

HIGHLIGHTS:

� Application of QbD and life cycle principles to pharmaceutical analysis

� Understanding the Analytical Target Profile (ATP)

� Decision rules and establishment of acceptance limits

� QbD-Method development � Traditional versus QbD Validation � Life-cycle and change management � Five hours of interactive workshops

1 – 2 October 2015, Budapest, Hungary

Quality by Design in Pharmaceutical Analysis

This education course is recognised for the ECA GMP Certification Programme „Certified Pharmaceutical Development Manager“. Please find details at www.gmp-certification.eu

� With practical oriented workshop case studies

Objectives

The aim of this two day course is to provide guidance on how QbD principles can be applied to analytical meth-ods and identify the opportunities, not only for new de-velopment products, but also for drugs already market-ed. This course will deal among others with the following questions:

� What are the opportunities of applying QbD and life cycle approach to analytical methods?

� What is the current status of analytical QbD (USP, FDA-EMA, FDA Draft Guidance Method Validation)?

� How can the Analytical Target Profile increase regulatory flexibility?

� Why is it important to have a clear understanding and expectation of method performance?

� What is the impact of QbD on method development, validation and transfer?

� What is the advantage of the 3-Stage lifecycle approach to validation?

� How can QbD also benefit marketed products?

A number of interactive workshops will be provided throughout the two days which will enable delegates to to apply what they have learnt and to discuss the con-cepts in more detail. Delegates will have the opportunity to work through the whole QbD process by gaining “hands-on experience” using a number of case studies.

Background

The pharmaceutical industry is currently embracing QbD concepts to help improve the robustness of manufactur-ing processes and to facilitate continuous improvement strategies to enhance product quality and manufacturing productivity. QbD ensures product and process perform-ance characteristics are scientifically designed to meet specific objectives, not merely empirically derived from the performance of test batches. Key QbD concepts are described in ICH guidelines Q8 (R1) Pharmaceutical Development, Q9 Quality Risk management and Q10 Pharmaceutical Quality System. The same opportunities exist for applying QbD to analytical methods as they do for manufacturing processes.

During the course an overview of a position paper written jointly by PhRMA and EFPIA and of a USP Stimuli Article will be provided which use a new concept called the Analytical Target Profile (ATP). It parallels the concept of a Quality Target Product Profile described and defined in ICH Q8 and defines the performance requirements for the measurement of a given Quality Attribute. The ATP will be used to drive all analytical life cycle activities within the three stages (Method Design, Method Perfor-mance Qualification, Continued Method Performance Verification) including change control.

It is hoped that greater continuous improvement of methods can also be facilitated if regulatory authorities agree with and approve the ATP statement. Each method conforming to the ATP requirements would be imple-mented by the company’s internal change control man-agement system, thus providing regulatory flexibility. Risk assessment tools and statistical methods used to facilitate understanding of the method performance characteris-tics (e.g. accuracy and precision) and their acceptance criteria will also be covered. Traditional method valida-tion will be compared to a QbD approach which in-cludes life-cycle aspects instead of a one off validation exercise.

Note: In order to fully benefit from the workshops, attendees should preferably bring a notebook with Excel®.

Target Audience

This course is designed for analytical managers and sci-entists who are responsible for performing or reviewing activities like method development, validation, transfer, operation and monitoring of methods in a QC environ-ment, statistical evaluation of method performance, ana-lytical change control etc.

In addition, QA and regulatory affairs professionals will benefit from this course by gaining an understanding in future CMC trends. This will aid more effective multifunc-tional discussions on these topics within industry.

Programme

Introduction to Analytical QbD � Overview on proposals of EFPIA/PhRMA Paper and

USP Stimuli Article � Analytical Target Profile � Application of QbD principles to pharmaceutical

analysis � Change Control and regulatory flexibility

Design Intent of the Method – ATP and Business Re-quirements

� Linkage with process control strategy (critical quality attributes)

� Definition of ATP � Method Performance Characteristics and their criteria � Business requirements of method

Understanding the ATP – Analytical Variability � Sources of analytical variability � Method performance characteristics: accuracy and

precision � Method performance and expectation ranges for

experimental results and statistical parameters � Decision rules and establishment of acceptance limits

Quality by Design in Pharmaceutical Analysis

1 – 2 October 2015, Budapest, Hungary

Workshop on Variability � Application of statistical simulations � Gain experience (“feeling”) for the consequences of

variability � Method performance statistical measures for

precision, accuracy, linearity � Probability of OOS and out-of acceptance criteria

situations

QbD Method Development � Method design � Method selection � Risk assessment � Control Definition of method (robustness and

ruggedness testing)

Workshop Risk Assessment � Use of fishbone diagrams � Identification of controllable factors, noise factors

and experimental parameters (CNX) � Use of priority matrix and failure mode and effects

analysis (FMEA)

Traditional Validation versus QbD Validation � “Translation” of ATP into specific method require-

ments � Identification of relevant performance parameters � Establishment of appropriate acceptance criteria � Life-cycle approach, continued performance

verification

Life-cycle and change management � Knowledge management system � Analytical Method Transfer � Routine method operation � Continuous method verification, change control and

regulatory implications

Workshop Case StudiesStarting from provided ATPs for several critical quality attributes, delegates will be split into small groups in order to discuss how each ATP is translated into meth-od specific performance characteristics and acceptance criteria. The impact of changing the method will be as-sessed for each ATP. Examples of Critical Quality attrib-utes will be used such as

� Identification of an API in a tablet formulation � Assay of drug substance � Water content in drug substance � Determination of degradants in drug product

Wrap up & Final DiscussionThe concepts and tools used over the two days will be summarised and future implications and opportunities of applying QbD principles to analytical measurements will be discussed. Delegates will be given time to ask ques-tions on how they can apply what they have learnt to their own analytical methods.

Speakers

DR JOACHIM ERMERHead of Quality Control Services Chemis-try, Sanofi-Aventis Deutschland GmbH, Frankfurt, Germany. He studied biochemis-try at University of Halle and has over 20 years experience in pharmaceutical analyt-ics including development products, glob-

al responsibilities as Director of Analytical Processes and Technology, and Head of Quality Control. He is member of the EFPIA QbD working group and of the USP Expert Panel Validation & Verification.

DR PATRICK JACKSONPatrick Jackson is an analyst at GSK leading analytical quality by design application within Product Development, Stevenage, UK with more than 8 years experience in the pharmaceutical industry working on Active Pharmaceutical Ingredients and

chemical route development. Pat studied at York Univer-sity where he obtained a Masters in Chemistry and later obtained a Masters in Applied Statistics from Sheffield Hallam University. Pat is also an associate member of The Royal Society of Chemistry.

Social Event

On 1 October 2015, you are cordially invited to a social event. This is an excellent opportunity to share your experiences with colleagues from other companies in a relaxed atmosphere.

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Reservation Form:CONCEPT HEIDELBERGP.O. Box 10 17 6469007 HeidelbergGermany

Reservation Form:+ 49 6221 84 44 34 @ e-mail:

info@concept-heidelberg.de Internet:www.gmp-compliance.org

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Date

Thursday, 1 October 2015, 9.00 h – 18.15 h(Registration and coffee 8.30 h – 9.00 h)Friday, 2 October 2015, 9.00 h – 15.30 h

Venue

Hilton Budapest WestEndVáci út 1-31062 Budapest, HungaryPhone +36 1 288 5500Fax +36 1 288 5588 Fees (per delegate plus VAT)

ECA Members € 1,590APIC Members € 1,690Non-ECA Members € 1,790EU GMP Inspectorates € 895The conference fee is payable in advance after re-ceipt of invoice and includes conference docu-mentation, dinner on the first day, lunch on both days and all refreshments. VAT is reclaimable.

Accommodation

CONCEPT HEIDELBERG has reserved a limited number of rooms in the conference hotel. You will receive a room reservation form when you have registered for the course. Reservation should be made directly with the hotel. Early reservation is recommended.

Registration

Via the attached reservation form, by e-mail or by fax message. Or you register online at www.gmp-compliance.org.

Conference Language

The official conference language will be English.

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CONCEPT HEIDELBERGP.O. Box 10 17 64 69007 HeidelbergGermanyPhone ++49-62 21/84 44-0 Fax ++49-62 21/84 44 84info@concept-heidelberg.dewww.concept-heidelberg.de

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