PCS-certification for the Responsible Person (RP) and Designated Person (API).
GMP & GDP training for pharma & biotech
Explain, implement and safeguard GDP legislation and regulations in your own organization
Applying the basic quality systems to GDP-related topics
Carry out the RP/DP's responsibilities in accordance with the GDP regulations
Dates | Language | Price | Register |
---|---|---|---|
5/20/25 to 5/20/25 | Dutch spoken language (primary) | € 795.00 | Register |
Subject | Mode |
---|---|
Basics of distributing medicines
|
eLearning |
Quality Management
|
eLearning |
Personnel
|
eLearning |
Premises and Equipment
|
eLearning |
Documentation
|
eLearning |
Operations
|
eLearning |
Complaints, returns, suspected falsified medicinal products and medicinal product recalls
|
eLearning |
Outsourced Activities
|
eLearning |
Self-Inspection
|
eLearning |
Transportation
|
eLearning |
Brokers
|
eLearning |
Lecture | Day |
---|---|
Introduction and Learning Goals
|
1 |
Introduction to GDP
|
1 |
Workshop: Change in activities
|
1 |
Workshop: Qualification of suppliers
|
1 |
Quality Management Review in GDP
|
1 |
Workshop: Dealing with a temperature excursion
|
1 |
Expectations of the Dutch regulatory inspectorate (IGJ)
|
1 |
Workshop: Temperature mapping in the warehouse
|
1 |
Workshop: Validation and change in transport
|
1 |
Workshop: GDP in your own practice
|
1 |
Evaluation and closure
|
1 |
You will follow an eLearning course lasting between 6 to 8 hours (depending on how quickly you want or can follow it). The eLearning will be sent to you in a timely manner.
Download our training brochure for 2024 by clicking this link