GMP for Mid-Level Management in the Pharmaceutical Industry

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

Language:
3 days in total

€ 1956.00 ex. VAT

Registration ends in 9 days.

The upcoming start date of this training is guaranteed.

This training contains:

Accreditation for openbaar apothekers (KNMP), 19.5 accreditation points

Accreditation for ziekenhuisapothekers (NVZA), 19.5 accreditation points

Lunch

Course dinner

Digital copy of materials

Training certificate

What you will learn

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

Training Dates

Start date	End date	Dates	Language	Venue	Price	Register
Monday, December 2, 2024	Wednesday, December 4, 2024	12/2/24 to 12/4/24	Dutch spoken language (primary)	Hotel Van der Valk Utrecht	€ 1956.00	Register
Tuesday, March 18, 2025	Thursday, March 20, 2025	3/18/25 to 3/20/25	English spoken language (primary)	Hotel Van Der Valk Breukelen	€ 1956.00	Register
Tuesday, May 13, 2025	Thursday, May 15, 2025	5/13/25 to 5/15/25	Dutch spoken language (primary)	Hotel Van Der Valk Breukelen	€ 1956.00	Register
Tuesday, September 16, 2025	Thursday, September 18, 2025	9/16/25 to 9/18/25	Dutch spoken language (primary)	Hotel Van Der Valk Breukelen	€ 1956.00	Register
Tuesday, November 25, 2025	Thursday, November 27, 2025	11/25/25 to 11/27/25	Dutch spoken language (primary)	Hotel Van Der Valk Breukelen	€ 1956.00	Register

Description

The Training

This three-day course provides an overview of the key aspects of quality management for middle management.

This well-established course offers an overview of the most important aspects of quality control. Knowledge and understanding at the middle management level play an indispensable role in this. This group is often heavily involved in setting up, improving, and applying quality systems. The training covers the essential elements of a quality system and supporting activities such as validation, qualification, and change control. This year, the course content has been updated to reflect the latest developments in GMP concerning the changes in European guidelines.

Please note! The March edition will be conducted in English unless there are no English-speaking participants in attendance.

Target Audience

This training is frequently attended by QA Officers & Managers, QPs, QC Managers & Analysts, and Production Managers or Supervisors. It is suitable for those at the bachelor's or master's degree level.

This training is also suitable for openbaar apothekers and ziekenhuisapothekers, who will receive professional accreditation points.

Results

GMP is easier to interpret and translate into practice
Insight into 'gaps' within the organization
Awareness of the importance of GMP in daily operations

Laws and regulations
Quality Culture
Quality Systems
Documentation and Data Integrity
Validation
Raw materials and APIs
Pharmaceutical production (including packaging)
Quality Control
Outsourcing activities
Complaints and recalls
Storage and Distribution
Experiences of the Dutch Health and Youth Care Inspectorate (IGJ)
GMP in your own practice

Lecturers

Karen Zimmermann

Trainer

Pharmaceutical trainer, consultant, and coach with over 20 years of expertise in GMP (Good Manufacturing Practice) a...

Jolanda Tijmes

Trainer

Experienced senior consultant with extensive expertise in quality management within the pharmaceutical industry, wit...

Program

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 European Commission (EC) EMA, PIC/S, ICH, U.S. FDA, WHO	1
Chapter 1 - Pharmaceutical Quality System Quality systems Process Oriented 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 Responsibilities of Personnel 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
Annex 11: Computerized Systems Annex 11 and validation Critical points post-validation	2
Chapter 4 - Documentation Data Integrity GDocP	2
Chapter 5 - Production Critical parameters Introduction Contamination Control Strategy (CCS)	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
Chapter 6 - Quality Control Quality Control (QC) Out-of-Specification (OOS) Reference- and retention samples Sampling	3
Chapter 7 - Outsourced Activities Qualification of suppliers and contract acceptors	3
Risk Ranking Starting materials and suppliers Workshop	3
Regulatory Oversight By the Dutch regulatory inspectorate: Inspectie van de Gezondheidszorg en Jeugd (IGJ)	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

Practical Information

Accreditation:: Openbaar Apothekers (KNMP), 19.5 accreditation points, accreditation details on PE-online.

Ziekenhuisapothekers (NVZA), 19.5 accreditation points
Difficulty / Level:: Beginner level and Intermediate level
Group discounts:: 2 participants - 5%

3 participants - 10%

4 participants - 15%

4 participants - 20%

6+ participants - 25%
Language (upcoming edition):: Dutch spoken language (primary)

English spoken language (secondary)

Some lectures/lessons may be in the secondary language. The primary language remains the dominant spoken/written language during the training.
Learning form:: Classroom
Times:: Starts at approx. 09:30 and ends at approx. 17:30
Notes to the course dinner:: At the end of day 2, you will be offered a course dinner.

Reviews (269)

Based on 269 reviews

5 star reviews: 35%
4 star reviews: 58%
3 star reviews: 6%
2 star reviews: 1%
1 star reviews: 0%

Reviews prior to 2017 were paper-based and are not included below.

4 out of 5 stars

Strong points (and why):

How to approach improving quality culture in my team and lock gmp in everything we do

Review:

Grip on the entirety of gmp. When IGJ is invited and you allow questions over lunch and to connect with the inspector, then do not sit with three PCS personnel around the inspectors at the table, preventing most training participants from being able to make contact.

Maarten - Sr Facility Manager

2024

4 out of 5 stars

Strong points (and why):

Diepgang

Jeffrey Buntsma - supervisor engineering

2024

4 out of 5 stars

Strong points (and why):

Er zijn veel onderwerpen aan bod gekomen en je werd tijdens de training gestimuleerd om dit te vertalen naar de eigen werkvloer.

Nikki Wildhagen - QA Compliance Specialist

2024

4 out of 5 stars

Strong points (and why):

Genoeg afwisseling

Review:

Vaker beweegmomenten. Ga zo door!

Melissa Scholte - QA officer

2024

5 out of 5 stars

Strong points (and why):

Alle onderwerpen werden behandeld

Joke Beukers - QC analist

2024

4 out of 5 stars

Strong points (and why):

De interactie

Jasper - Automation engineer

2024

5 out of 5 stars

Strong points (and why):

De kansen om vragen te stellen

Matthias Groeneveld - Quality assistent manager

2024

5 out of 5 stars

Strong points (and why):

Juridische wetten vertalen naar praktijk. Afwisseling presentaties en workshops. Presentaties gasten.

Yvonne Hilkes - Kwaliteitsmedewerker

2024

4 out of 5 stars

Strong points (and why):

Afwisseling van onderwerpen en veel ruimte voor vragen.

Rikst - Analist

2024

4 out of 5 stars

Strong points (and why):

Duidelijke uitleg, trainers van goede kwaliteit

Review:

Eudralex boekje met wat label er tussen zodat je goed de hoofdstukken en annexen kan opzoeken. Niet zo’n lange workshop aan het eind.

Amber - Junior GxP Consultant

2024

5 out of 5 stars

Strong points (and why):

Interactiviteit en de diepgang van de stof.

Review:

Super gedaan en bedankt voor de info! Krijgen we het SLA voorbeeld van de spreker?

Karlijn - Hoofd productie

2024

5 out of 5 stars

Strong points (and why):

Goede informatie, genoeg workshops tussendoor

Audrey - Productie specialist

2024

€ 1956.00 ex. VAT

Registration ends in 9 days.

The upcoming start date of this training is guaranteed.

Difficulty:

Beginner level Intermediate level