Documenti di Didattica
Documenti di Professioni
Documenti di Cultura
Education Course
Speakers:
Dr Ulrich Kissel
European QP Association
Understand the Implications
Savvas Koulouridas
Fagron BV, The Netherlands
of Working as a QP
Aidan Madden
29/30 October 2019, Barcelona, Spain
FivePharma, Ireland
Sue Mann
Sue Mann Consultancy, U.K.
Rico Schulze
GMP Inspectorate, Local
Authorities, Germany
Lance Smallshaw
UCB, Belgium
“Very enjoyable and engaging.” “Thanks for great opportunity for improving my knowledge and
Jason Fagg, Leyden Delta B.V., The Netherlands change experience! Excellent Organization!“
Iryna Martynchyk, JSC Pharmaceuticals
Programme
The Legal and Professional Duties of the Qualified
Person
yy The Qualified Person within the EU legislation and
regulation framework
yy Professional tasks, duties and responsibilities
Dr Ulrich Kissel yy Expectations of an EU GMP Inspector
Moderator
Wolfgang Schmitt
How the QP fits into the Quality Systems Speakers
yy How much involvement is needed in systems like:
yy Product Quality Review
yy Inspection Management Dr Ulrich Kissel
yy Batch Record Review European QP Association
yy CAPA Ulrich Kissel is Qualified Person and Chairman
yy Change Control of the Board of Directors of the European
yy Validation Qualified Person Association (EQPA). He works
yy Complaints and recalls as a GMP consultant and contract QP to the
yy Batch certification and release Pharmaceutical Industry. Previous to his current role he held
yy Laboratory investigations
leadership positions in Quality and Supply Chain and served
for many years as QP for Roche.
Lance Smallshaw
UCB, Belgium
Lance Smallshaw is Director of Analytical and
Quality Competitive Intelligence at UCB
Biopharma, working in the Corporate Analyti-
cal Sciences Team. He is also Co-Chair of the
Executive Board of ECA and Associate Director and Euro-
pean CMC Strategy Committee member for CaSSS Biop-
harm.
Easy Registration
Reservation Form:
CONCEPT HEIDELBERG Reservation Form:
+ 49 6221 84 44 34 @ e-mail:
info@concept-heidelberg.de www.qp-association.eu
Internet:
P.O. Box 10 17 64
69007 Heidelberg, Germany
Conference language
Date
The official conference language will be English.
Tuesday, 29 October 2019, 9.00 – 18.00h
(Registration and coffee 8.30 – 9.00) Organisation / Contact
Wednesday, 30 October 2019, 8.30 – 15.30 h CONCEPT HEIDELBERG
P.O. Box 10 17 64
Venue D-69007 Heidelberg, Germany
Barcelo Sants Hotel Phone +49 (0) 62 21/84 44-0
Pl. Països Catalans, s/n Fax +49 (0) 62 21/84 44 34
08014 Barcelona, Spain info@concept-heidelberg.de,
Tel.: +34 93 503 53 00 www.concept-heidelberg.de
Fax:+34 93 4906045
sants@barcelo.com For questions regarding content please contact:
Mr Wolfgang Schmitt (Operations Director) at
Fees (per delegate plus VAT) +49 (0) 62 21 / 84 44 39, or per e-mail at
QP Association Members € 1,490 w.schmitt@concept-heidelberg.de.
ECA Members € 1,490
Non-ECA/ Non-QP Association Members € 1,690 For questions regarding reservation, hotel, organisation,
EU GMP Inspectorates € 845 etc please contact:
Mr Rouwen Schopka (Organisation Manager) at
Accommodation +49 (0) 62 21 / 84 44 13, or per e-mail at
CONCEPT has reserved a limited number of rooms in the confer- schopka@concept-heidelberg.de.
ence hotel. You will receive a room reservation form/POG when
you have registered for the course. Reservation should be made
directly with the hotel. Early reservation is recommended.
If the bill-to-address deviates from the specification Reservation Form (Please complete in full)
to the right, please fill out here:
Qualified Person Education Course – Understand the Implications of
Working as a QP
29/30 October 2019, Barcelona
Mr
* *
Ms
Company Department
Important: Please indicate your company’s VAT ID Number and your PO Number
General terms and conditions If the event must be cancelled, registrants will be In case you do not appear at the event without Privacy Policy: By registering for this event,
If you cannot attend the conference you have notified as soon as possible and will receive a full having informed us, you will have to pay the I accept the processing of my Personal Data.
two options: refund of fees paid. CONCEPT HEIDELBERGwill full registration fee, even if you have not made Concept Heidelberg will use my data for the
1. We are happy to welcome a substitute col- not be responsible for discount airfare penalties the payment yet. Only after we have received processing of this order, for which I hereby de-
league at any time. or other costs incurred due to a cancellation. your payment, you are entitled to participate in clare to agree that my personal data is stored and
2. If you have to cancel entirely we must charge Terms of payment: Payable without deductions the conference (receipt of payment will not be processed. Concept Heidelberg will only send me
the following processing fees: Cancellation within 10 days after receipt of invoice. confirmed)! (As of January 2012). information in relation with this order or similar
until 2 weeks prior to the conference 10 %, Important: This is a binding registration and ones. My personal data will not be disclosed to
until 1 weeks prior to the conference 50 % above fees are due in case of cancellation or non- German law shall apply. Court of jurisdiction is third parties (see also the privacy policy at http://
within 1 week prior to the conference 100 %. appearance. If you cannot take part, you have to Heidelberg. www.gmp-compliance.org/eca_privacy.html). I
CONCEPT HEIDELBERG reserves the right to inform us in writing. The cancellation fee will then note that I can ask for the modification, correction
change the materials, instructors, or speakers be calculated according to the point of time at or deletion of my data at any time via the contact
without notice or to cancel an event. which we receive your message. form on this website.