Let op! De editie in maart zal in het Engels gegeven worden tenzij er geen Engelstalige deelnemers in de zaal aanwezig zijn.
This training provides an overview of the key aspects of quality control for middle management.
Based on 963 participants
GMP & GDP training for pharma & biotech
€ 1956.00 ex. VAT
Registration ends in 51 days.
Register now!The upcoming start date of this training is guaranteed.
Implementing GMP from theory to practice, including Quality Culture
Effectively deal with the unique position of mid-level management in the pharmaceutical industry
Identify the importance and essence of GMP, through a solid understanding of the rules and regulations
Let op! De editie in maart zal in het Engels gegeven worden tenzij er geen Engelstalige deelnemers in de zaal aanwezig zijn.
Lecture | Day |
---|---|
Learning goals and course contents
Introduction
Learning goals
Kahoot! Quiz
|
1 |
The Pharmaceutical Industry Today
Current developments in the pharmaceutical industry
|
1 |
GMP Rules and Regulations
History
EudraLex Volume IV
Dutch Medicines Act
Licenses
Europese Commission (EC)
EMA, PIC/S, ICH, U.S. FDA, WHO
|
1 |
Chapter 1 - Pharmaceutical Quality System
Quality systems
Modern GMP
|
1 |
Chapter 1 - Pharmaceutical Quality System: the essential elements
Change Control
Deviations
CAPA's
Risk Management
|
1 |
Deviations
Deviation Workshop
|
1 |
Chapter 2 - Personnel
Personnel responsibilities
The importance of training
Introduction to Quality Culture
Human Error
|
1 |
Closing the first day
|
1 |
Lecture | Day |
---|---|
Introduction day 2
|
2 |
Chapter 3 - Premise and Equipment
Introduction
|
2 |
Equipment, Validation, Calibration and Verification
Equipment
What is validation, calibration and verification?
Validation according to the Primary Process & V-model
Examples
Cleaning validation
|
2 |
Chapter 4 - Documentation
GMP documentation
|
2 |
Regulatory Oversight
By the Dutch regulatory inspectorate: Inspectie van de Gezondheidszorg en Jeugd (IGJ)
|
2 |
Chapter 4 - Documentation
Data Integrity
GDocP
|
2 |
Chapter 5 - Production
Introduction
Critical parameters
Contamination Control Strategy (CCS)
|
2 |
Risk Ranking
Starting materials and suppliers
Workshop
|
2 |
The Role of the Qualified Person
Regulations
Responsibilities
Qualification of a QP
Batch release process
|
2 |
Closing the second day
|
2 |
Lecture | Day |
---|---|
Introduction to day 3
|
3 |
Annex 11: Computerized Systems
Annex 11 and validation
Critical points post-validation
Reference- and retention samples
Sampling
|
3 |
Chapter 7 - Outsourced Activities
Qualification of suppliers and contract acceptors
|
3 |
Chapter 6 - Quality Control
Quality Control (QC)
Out-of-Specification (OOS)
|
3 |
Chapter 8 - Complaints and Product Recalls
|
3 |
Chapter 9 - Self Inspection
|
3 |
Workshop - What Went Wrong?
Analysis of the consequences and actions to be taken in the event of an inadequate quality management system
|
3 |
Discussing Workshop Results
|
3 |
GMP In Your Own Daily Practice
|
3 |
Quiz & Closing the course
|
3 |
Course dinner is only on the second day of the training.
€ 1956.00 ex. VAT
Registration ends in 51 days.
Register now!The upcoming start date of this training is guaranteed.
Download our training brochure for 2024 by clicking this link