ECA Responsible Person GDP
ECA Responsible Person GDP
ECA Responsible Person GDP
Speakers:
Dr Martin Egger
Pharmaserv Logistics
Dr Afshin Hosseiny
Chair of the European GDP
Association
Highlights
Dr Daniel Mller
GMP/GDP Inspector The EU GDP Guidelines
Roles and Responsibilities of the Responsible Person
What to learn from GMP/GDP Inspections and Audits
Storage and Transport:
- Warehouse Management
Dr Laura Ribeiro
- Controlled Temperature Distribution
ID Logistics
- Track & Trace
Working with 3PL Service Providers
in cooperation with
This course is recognised for the ECA GMP Certification Programme Certified GDP Compliance Manager. Please find details at www.gmp-certification.eu
The Responsible Person for Good Distribution Practices (GDP)
3-4 May 2018, Copenhagen, Denmark
Objectives The EU GDP Guidelines require that wholesale distributors have to appoint a
Responsible Person (RP) for GDP. There has been a lot of discussion about the
duties of the RP. Therefore, the ECA Foundations GDP Working Group has
developed this training course. In this course, the role and responsibilities of
the Responsible Person for GDP will be highlighted and discussed.
Target Audience The Training Course is of particular interest to Responsible Persons but also
management and quality personnel from pharmaceutical companies, wholesal-
ers, distributors and service providers involved in distribution of medicinal
products for human use.
Programme
The EU GDP Guidelines The counterfeit directive and the introduction of the EU GDP Guidelines
GDP requirements for the pharmaceutical supply chain
Regulatory expectations for implementation
Inspections of the competent authorities
Case Study: Management of a Outsourcing in Pharma Logistics current trends & benefits
GMP warehouse and distribu- Determining the scope of Outsourcing
tion of medicinal products Processes, roles & responsibilities
with a 3PL-Approach Monitoring of critical data
Reporting of the performance & controlling of the 3PL
Speakers
P.O. Box 10 17 64
69007 Heidelberg
Germany
Date The conference fee is payable in advance For questions regarding content:
Thursday, 03 May 2018, 09:00 h 17:45h after receipt of invoice and includes con- Mr Wolfgang Schmitt
(Registration and coffee 08:30 h 09:00 h) ference documentation, dinner on the first (Operations Director) at
Friday, 04 May 2018, 08:30 h 15:30 h day, lunch on both days and all refresh- +49-62 21/84 44 39, or per e-mail at
ments. VAT is reclaimable. [email protected].
Venue
Radisson Blu Royal Hotel Registration For questions regarding reservation,
Hammerichsgade 1 Via attached reservation form, by e-mail or hotel, organisation etc.:
1611 Copenhagen V, Denmark by fax message. Or you register online at Ms Nicole Bach
Phone +45 33 42 60 00 www.gmp-compliance.org. (Organisation Manager) at
Fax +45 33 42 61 00 +49-62 21/84 44 22, or per e-mail at
[email protected] Conference language [email protected].
The official conference language will be
Accommodation English. Social Event
CONCEPT HEIDELBERG has reserved a lim- On the evening of the first conference
ited number of rooms in the conference Organisation and Contact
day of the training course you are cor-
hotel. You will receive a room reservation ECA has entrusted Concept Heidelberg
with the organisation of this event. dially invited to a social event. This is
form/POG when you have registered for
the course. Reservation should be made an excellent opportunity to share your
directly with the hotel. Early reservation is CONCEPT HEIDELBERG experiences with colleagues from oth-
recommended. P.O. Box 10 17 64 er companies in a relaxed atmosphere.
69007 Heidelberg, Germany
Conference fees (per delegate plus VAT) Phone +49 (0) 62 21/84 44-0
ECA Members 1,590 Fax +49 (0) 62 21/84 44 34
European GDP Association [email protected]
Members 1,590 www.concept-heidelberg.de
QP Association Members 1,590
APIC Members 1,690
Non-Members 1,790
EU GMP Inspectorates 895
+49 6221 84 44 34
If the bill-to-address deviates from the Registration form (please complete in full)
specification to the right, please fill out here:
The Responsible Person for Good Distribution Practices (GDP)
3-4 May 2018, Copenhagen, Denmark
0 Mr 0 Ms Title ___________
Company
Department
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Important: Please indicate your companys VAT ID Number
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