
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, 1st and 2nd party audits, training etc. She is also 3rd 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