Batch Documentation Review | Pharma Training Course | PCS Academy

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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:
    Dutch flag
  • 1 day in total

€ 1197.00 ex. VAT

Registration ends in 52 days.

Reserve your seat

Awaiting approval? Pre-register now — no obligation Open
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

    Dates Language Price Register
    9/24/26 to 9/24/26 Dutch spoken language (primary) Dutch spoken language (primary) € 1197.00 Register for this date
    4/1/27 to 4/1/27 Dutch spoken language (primary) Dutch spoken language (primary) € 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

    Contents

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

    Program

    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):
    • nl flag Dutch spoken language (primary)
    • en flag 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 avatar

    Ali Aziz

    Trainer

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

    Tags

    Change Control GMP GDP EudraLex Volume IV Medicines Act Deviations Quality Assurance Quality Culture Batch Review Manufacturing Data Integrity ALCOA Raw Data CAPA Impact Assessment Human Error QMS Batch Record Awareness Quality Awareness

    Reviews (57)

    4 out of 5 stars

    Based on 57 reviews

    Review data

    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

    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

    5 out of 5 stars

    Strong points (and why):

    Interactief

    Miranda schils - Qa functie

    4 out of 5 stars

    Strong points (and why):

    Interactief

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

    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

    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.

    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

    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

    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

    4 out of 5 stars

    Strong points (and why):

    Het niet blindstaren op een bepaalde root cause

    Arjan Mosselman - Production Project Manager

    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

    5 out of 5 stars

    Strong points (and why):

    Human error

    Leoni Lutke Schipholt - QA Officer

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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
    Difficulty:
    Beginner level Intermediate level
    This training contains:
  • Lunch
  • Digital copy of materials
  • Training certificate
    • Training 5 or more people from the same site?

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