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.
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:firstname.lastname@example.org
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.