Numarul minim de participanti pentru organizarea unei sesiuni de curs este de 15 cursanti. In functie de numarul inscrierilor, data propusa pentru desfasurarea unui training poate suferi modificari.
- Acest eveniment a trecut.
DISTRIBUTION OF MEDICINAL PRODUCTS, MEDICAL DEVICES AND FOOD SUPPLEMENTS in European Union (EU)
septembrie 20 @ 4:00 pm - septembrie 22 @ 8:00 pm
Risk based & applied approach for implementation of regulatory (GDP) requirements, by Contract Giver and Contract Acceptor
Online Training – Live via Microsoft Teams
20-22nd of September 2021, 16.00-20.00 CET
A. Applicable legislative requirements for EU distribution of medicinal products, medical devices (including MDR 745) and food supplements.
B. Suppliers Selection and evaluation (e.g.: warehousing, logistics services, transportation, IT platforms, other services, equipment / maintenance service providers).
B1. General considerations and specificities correlated with service type, regarding:
- Contracts management and operational protocol Contract Giver/Acceptor
- Defining performance indicators
- Responsibilities of the parties
B2. Evaluation process for suppliers involved in distribution related activities.
- Suppliers’ qualification
- Risk management in the qualification, evaluation, and monitoring of service providers activities
- Evaluation Questionnaires and Audits (collection and evaluation of evidence, monitoring of corrective measures)
B3. Service compliance monitoring, during contractual period.
B4. Risk management for warehousing & distribution activities.
Important aspects related to the course: Theoretical concepts supported with practical examples. Interactive sessions. Case studies.
Pharm Elena Georgescu/Romania – expertise acquired along 25 years of pharma experience, including 7 years of consultancy services in pharma industry GxP compliance & over 50 GxP audits (as auditor and auditee) (Elena Georgescu | LinkedIn)
To participate in the course, click the „Enroll” button, download the Registration Form, and send it completed and signed to the address:email@example.com
The maximum number of participants for organizing a course session is 15 students. Depending on the number of registrations, the proposed date for conducting a training may change.