Storage and Distribution of Medicinal Products

SPECIALIZED SEMINAR IN ROMANIA

Thursday        September     12,       2019

Friday             September      13,       2019

10:00 – 15:00     

CENTRAL HOTEL IN BUCHAREST

Good Storage and Good Distribution Practises (GSP-GDP) of Medicinal Products

Who should attend?
The seminar is addressed to managers and staff of organizations that store, distribute or handle medicinal products, as well as to other persons interested to increase their knowledge on this particular field.

SEMINAR SCOPE
Seminar scope is to present and analyse the European Union Guidelines as concerns the “Good Distribution Practice of medicinal products for human use” 2013/C 343/01, 05/11/2013.

Workshops will be used to facilitate understanding.

Instructor
The tutor is chemical engineer, with working experience as manager (QA/QC, provisions, etc) in medicines and medical devices manufacturing companies. Ms A. Georgiou is now freelancer, acting as consultant for the implementation of Management Systems, 1^st and 2^nd party audits, training etc. She is also 3^rd party lead auditor in Management Systems according to ISO standards, eg ISO 9001:2015, ISO 13485:2016, ISO 22716:2007 etc.

SEMINAR CONTENT
Legislation related to medicinal products GSP/GDP
Good Storage Practices (GSP) – requirements:
 Quality Management
 Personnel
 Premises and equipment
 Documentation
 Operations (suppliers, customers, receipt of products, storage, destruction of obsolete goods, picking, supply, export to third countries)
 Complaints, returns, suspected falsified, recalls
 Outsourced activities
 Self – inspections
 Transportation (GDP)
 Specific provision for brokers

Program COORDINATOR: MATINA TSOCHALI, tel:0030 2114024187 Fax: 0030 210 – 3218765 e-mail: matina.tsochali@oikonomotexniki.gr