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.

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  • 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

TOPICS:

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.

SPEAKER

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:office@pharmatrained.com

Enroll

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.

Detalii

Începe:
septembrie 20 @ 4:00 pm
Se termină:
septembrie 22 @ 8:00 pm

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