Académique Documents
Professionnel Documents
Culture Documents
of Analytical Procedures
(USP):
Dr CHRISTOPHER BURGESS
Burgess Analytical Consultancy
Limited
USP and ECA Joint Conference and Workshop
GREG MARTIN
Complectors Consulting, Chairman
of the Validation & Verification
Expert Panel at USP
Dr HORACIO PAPPA
Director of General Chapters at USP
Dr PAULINE MCGREGOR
PMcG Consulting
JANE WEITZEL
Consultant
ELISABETH KOVACS
Apotex
KIMBER BARNETT
Pfizer
Dr JOACHIM ERMER
Sanofi
PATRICK JACKSON
GSK
HIGHLIGHTS:
Introduction to a new USP General Chapter on Validation &
Dr BOB MCDOWALL Verification
R D McDowall Ltd.
Review of the revision process for USP General Chapters
Speakers from Authorities: <1225>, <1224> and <1226>
Analytical Target Profile and Measurement Uncertainty
Dr LUCINDA BUHSE
Food and Drug Administration Application of AQbD principles in procedure lifecycle
(FDA), Member of the Validation &
Verification Expert Panel at USP Analytical Control Strategy
Fitness for purpose of analytical instruments and systems
JAMES POUND
Overview of statistical tools
Editor-in-Chief British Pharmaco-
poeia (BP), MHRA Continued verification
Current regulatory vision for Analytical Lifecycle
DR JOBST LIMBERG
Federal Institute for Drugs and
Medical Devices, BfArM
Lifecycle Approach of Analytical Procedures
USP and ECA Joint Conference and Workshop
8-9 November 2016, Prague, Czech Republic
Dr Joachim Ermer
Sanofi, Member of the Validation & Verification Ex- On 8 November 2016, you are cordially invited to a
pert Panel at USP social event. This is an excellent opportunity to share
Dr Ermer is Head of Quality Control Services your experiences with colleagues from other companies
Chemistry, Sanofi-Aventis Deutschland GmbH, Frankfurt, in a relaxed atmosphere.
Germany and Global Reference Standards Coordinator
of Sanofi Industrial Affairs. He studied biochemistry at
University of Halle and has over 25 years experience in Important Information!
pharmaceutical analytics including development prod- You will receive a USB memo stick containing all the
ucts, global responsibilities as Director of Analytical presentations when you register in Prague.
Processes and Technology, and Head of Quality Control. Note: there will be no print-outs available during the
He is member of the EFPIA QbD working group and of conference.
the USP Expert Panel Validation & Verification.
Easy Registration
Reservation Form:
CONCEPT HEIDELBERG Reservation Form:
+ 49 6221 84 44 34 @ e-mail:
info@concept-heidelberg.de Internet:
www.validation-analytical.com
P.O. Box 10 17 64
69007 Heidelberg, Germany
Date Registration
Tuesday, 8 November 2016, 9.00 h – 18.00 h Via the attached reservation form, by e-mail or by fax message.
(Registration and coffee 8.00 h – 9.00 h) Or you register online at www.validation-analytical.com.
Wednesday, 9 November 2016, 8.30 h – 18:00 h
Conference language
Venue
The official conference language will be English.
Corinthia Hotel Prague
Kongresova 1 Organisation and Contact
14069 Prague 4
Czech Republic ECA has entrusted Concept Heidelberg with the organisation of this
Phone +(0) 420 261 191 111 event
Fax +(0) 420 261 225 011
CONCEPT HEIDELBERG
Fees (per delegate plus VAT) P.O. Box 10 17 64
D-69007 Heidelberg
Germany
ECA Members € 1,590 Phone +49 (0) 62 21/84 44-0
APIC Members € 1,690 Fax +49 (0) 62 21/84 44 34
Non-ECA Members € 1,790 info@concept-heidelberg.de
EU GMP Inspectorates € 895 www.concept-heidelberg.com
The conference fee is payable in advance after receipt of invoice and
includes conference documentation, social event & dinner, lunch on For questions regarding content:
both days, and all refreshments. VAT is reclaimable. Dr Andrea Kühn-Hebecker (Operations Director)
at +49-62 21/84 44 35, or per e-mail at kuehn@concept-heidelberg.de.
Accommodation
For questions regarding reservation, hotel, organisation etc.:
CONCEPT HEIDELBERG has reserved a limited number of rooms in the Marion Weidemeier (Organisation Manager)
conference hotel. You will receive a room reservation form when you at +49-62 21/84 44 46,
have registered for the course. Reservation should be made directly with or per e-mail at weidemeier@concept-heidelberg.de.
the hotel. Early reservation is recommended.
+49 6221 84 44 34
If the bill-to-address deviates from the Reservation Form (Please complete in full)
specification to the right, please fill out here: Lifecycle Approach of Analytical Procedures
USP and ECA Joint Conference and Workshop
8-9 November 2016, Prague, Czech Republic
Mr Ms
Company
Department
Important: Please indicate your company’s VAT ID Number Purchase Order Number, if applicable
CONCEPT HEIDELBERG
P.O. Box 10 17 64 Street / P.O. Box
Fax +49 (0) 6221/84 44 34
City Zip Code
69007 Heidelberg
Germany
Country
Phone / Fax
General terms and conditions CONCEPT HEIDELBERG reserves the right to change the Important: This is a binding registration and above fees
If you cannot attend the conference you have two options: materials, instructors, or speakers without notice or to are due in case of cancellation or non-appearance. If you Privacy Policy: By registering for this event,
1. We are happy to welcome a substitute colleague at cancel an event. cannot take part, you have to inform us in writing. I accept the processing of my Personal Data. Concept
any time. If the event must be cancelled, registrants will be notified The cancellation fee will then be calculated according to Heidelberg will use my data for the processing of this order,
2. If you have to cancel entirely we must charge the follow- as soon as possible and will receive a full refund of fees the point of time at which we receive your message. for which I hereby declare to agree that my personal data
ing processing fees: Cancellation paid. CONCEPT HEIDELBERG will not be responsible for In case you do not appear at the event without having is stored and processed. Concept Heidelberg will only send
until 2 weeks prior to the conference 10 %, discount airfare penalties or other costs incurred due to informed us, you will have to pay the full registration me information in relation with this order or similar ones.
until 1 weeks prior to the conference 50 % a cancellation. fee, even if you have not made the payment yet. Only My personal data will not be disclosed to third parties (see
within 1 week prior to the conference 100 %. after we have received your payment, you are entitled to also the privacy policy at http://www.gmp-compliance.org/
Terms of payment: Payable without deductions within 10 participate in the conference (receipt of payment will not eca_privacy.html). I note that I can ask for the modification,
days after receipt of invoice. be confirmed)! (As of January 2012). correction or deletion of my data at any time via the
contact form on this website.