Batch Documentation Review

One-day training on the review and improvement of batch documentation and smooth communication processes.

Practical GMP & GDP training for pharma and biotech professionals — taught by senior PCS consultants who advise manufacturers on real GMP issues every week.

Language:
1 day in total

€ 1197.00 ex. VAT

Registration ends in 52 days.

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Awaiting approval? Pre-register now — no obligation Open

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This training contains:

Lunch

Digital copy of materials

Training certificate

What you will be able to do after this course

Apply GMP documentation requirements in practice

Work with people in a positive way

Raise the standard of completed batch documentation step by step

Upcoming dates — pick a seat

Start date	End date	Dates	Language	Venue	Price	Register
Thursday, 24 September 2026	Thursday, 24 September 2026	24/09/26 to 24/09/26	Dutch spoken language (primary)	PCS Training Room	€ 1197.00	Register for this date
Thursday, 1 April 2027	Thursday, 1 April 2027	01/04/27 to 01/04/27	Dutch spoken language (primary)	PCS Training Room	€ 1235.00	Register for this date

About this course

What this course covers

Reviewing batch documentation does not always run smoothly. The number of errors found, ambiguities and discussions can push the moment of release further and further back. It is therefore essential to make clear agreements so that review and release proceed effectively and efficiently.

During this one-day training you will learn what it takes to carry out the review of batch documentation properly and to communicate constructively.

Who this course is for

This training is intended for professionals in the pharmaceutical industry who are responsible for reviewing, for example, batch records, analytical results and validations.

This includes staff in the following departments: QA, QC, production, registration and validation. The training is also suitable for those who wish to set up a sound and efficient batch review process.

If you're a pharmacist or hospital pharmacist interested in earning accreditation points by attending this training,

What you take back to work

Errors are prevented by focusing attention
A smoothly running review process
Improved quality of batch records

The competencies of a batch reviewer
Documentation requirements
The review process
What makes a good Batch Record?
Observation
Learning from mistakes
Positive communication

Programme

Lecture	Day
Learning objectives and course content	1
What skills do you need as a Batch Reviewer? The importance of batch documentation Why are we discussing this in the first place? Competencies	1
The review process Structure of the review process Knowing the requirements the review procedure must meet	1
Batch and Analytical Documentation What does EU GMP expect? Batch documentation - who, what, why?	1
Learning from mistakes Becoming aware of the power of mistakes Ensuring continuous quality improvement	1
Raw Data & Data Integrity How is data defined? How data must be recorded according to GMP	1
Observation Awareness that the quality of the review is determined by the quality of the attention given	1
Action plan: from theory to practice Targeted actions to take forward	1
Quiz	1
Evaluation & closing	1

Practical Information

Difficulty / Level:: Beginner level and Intermediate level
Group discounts:: 2 participants - 5%

3 participants - 10%

4 participants - 15%

4 participants - 20%

6+ participants - 25%

Group discounts are only applicable when multiple participants register for the same course at the same time.
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 09:30 and ends at 17:30

Lecturer

Your trainers are practising PCS consultants. They spend most of their week helping pharma manufacturers respond to real GMP findings, audits and inspections — and bring that experience straight into the classroom.

Ali Aziz

Docent

Ali Aziz is an experienced Qualified Person (QP), QA Specialist and Responsible Person (RP) with...

Reviews (57)

Based on 57 reviews

5 star reviews: 21%
4 star reviews: 70%
3 star reviews: 9%
2 star reviews: 0%
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):

Gedeelte herhaling gedeelte nieuw, wat meer op de inhoud ging

Marlies van den Hil - Rp senior qa officer

2025

4 out of 5 stars

Strong points (and why):

Sommige onderdelen zijn voor mijn functie niet relevant. Echter, denk ik dat het wel nuttig is voor in de toekomst.

Ivo de Romph - Officier Quality Assurance

2025

5 out of 5 stars

Strong points (and why):

Interactief

Miranda schils - Qa functie

2025

4 out of 5 stars

Strong points (and why):

Interactief

Marleen Roding - Qualuty, R&D and labmanager, RP

2025

4 out of 5 stars

Strong points (and why):

CAPA management.

Review:

Onze organisatie liep wat vast met CAPA’s en hoop dat wij hier verder mee kunnen.

Anouk van der Hoorn - Quality officer

2022

4 out of 5 stars

Strong points (and why):

Besef van het verschil in aanpak bij de RCA: dit zorgt dat je wel/niet bij de essentie komt.

Review:

Goede training!

Amina Akka - QA/QP i.o.

2022

5 out of 5 stars

Strong points (and why):

Human error, RCA tools, deviatie classificatie

Review:

Human errors worden nog teveel als Rootcause aangeduid. Ik heb geleerd welke RCA tool het meest geschikt is voor een bepaalde deviatie en deviatie classificatie wordt bij ons bedrijf voor major en critical nog wel eens anders gebruikt.

Azra - QA Specialist

2022

4 out of 5 stars

Strong points (and why):

Alles eigenlijk wel

Review:

Beperkte kennis vooraf, dus veel bij kunnen leren dan wel bevestiging van hetgeen reeds geleerd

Renate van Bodegraven - Quality manager/RP

2022

5 out of 5 stars

Strong points (and why):

Eigenlijk alles

Review:

Heel interessant om te horen hoe het bij andere bedrijven gaat

Gaby van Snerkel (Ineveld) - Allround medewerker QA

2020

4 out of 5 stars

Strong points (and why):

Het niet blindstaren op een bepaalde root cause

Arjan Mosselman - Production Project Manager

2020

4 out of 5 stars

Strong points (and why):

Deviaties in algemeen, goed om meer inzichten te krijgen

Review:

Goede training, goed te volgen. Bedankt!

Michael Roovers - Senior Operator 2

2020

5 out of 5 stars

Strong points (and why):

Human error

Leoni Lutke Schipholt - QA Officer

2020

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Registration ends in 52 days.

Reserve your seat

Awaiting manager approval? Pre-register now. It's free and without obligation. We'll hold your interest and follow up when you're ready to confirm. Pre-register — no obligation

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Which date?

Comment (optional)

Difficulty:

Beginner level Intermediate level