Validation Best Practices
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Validation Best Practices

Training about all the ins and outs of validation

GMP & GDP training for pharma & biotech

  • Language:
    Dutch flag English flag
  • 1 day in total

€ 922.00 ex. VAT

Registration ends in 339 days.

Register now!

The upcoming start date of this training is guaranteed.

This training contains:
  • Lunch
  • Digital copy of materials
  • Training certificate
  • What you will learn

    Employ Quality by design in development of new processes

    Understanding the effect of good startup to avoid problems later on

    Systematically set up and plan validations in accordance with legislation

    Training Dates

    Dates Language Price Register
    9/23/25 to 9/23/25 Dutch spoken language (primary) € 922.00 Register

    Description

    The Training

    One-day training on validation according to the current understanding: design phase, qualification phase and continuous verification. The traditional way of validation, where a protocol is simply performed 3 times, is definitely behind us. Since the beginning of this century, several guidelines have been introduced in which the development and planning phase have become increasingly important in the life cycle of a pharmaceutical product or GMP system (and nowadays GDP).

    The emphasis is on Quality by Design, setting up Design of Experiments, performing risk analyses and establishing an efficient control system. Organizations often experience too late that their validation approach is insufficiently robust and therefore experience problems, such as registration or inspections, but also because processes do not run as expected. A solidly planned approach to validation is necessary to comply with regulations, but also to avoid financial and quality risks.

    The implementation of the underlying systems is also covered, such as Data Integrity, Good Documentation Practices and Risk Management which are very important components for the proper design of validations. PCS has introduced this training, in which this vision on validation and the underlying quality enablers are extensively covered. 

    Target Audience

    This training is for employees in the pharmaceutical industry who are involved in designing, implementing and collaborating on validation. For validators, production staff, QC, auditors, QA, QPs and managers

    Contents

    • Purpose of validation
    • Laws and regulations (including Annex 15, ICH Q8, Q9, Q11, FDA)
    • Design and execution of process validation
    • Design and execution of cleaning validation
    • Quality by design
    • Risk analyses
    • Establishing an efficient control system
    • Data Integrity as an important part of validation
    • Validation Master Plan
    • Reporting
    • Workshops - learning by doing

    Lecturer

    Adriënne Janssen avatar

    Adriënne Janssen

    Trainer

    Adriënne Janssen is a seasoned Freelance Pharma Consultant with over two decades of experience in the pharmaceu...

    Program

    Practical Information

    Difficulty / Level:
    Group discounts:
    • 2 participants - 5%
    • 3 participants - 10%
    • 4 participants - 15%
    • 4 participants - 20%
    • 6+ participants - 25%
    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

    Reviews (7)

    4 out of 5 stars

    Based on 7 reviews

    Review data

    5 star reviews

    0%

    4 star reviews

    86%

    3 star reviews

    14%

    2 star reviews

    0%

    1 star reviews

    0%

    4 out of 5 stars

    Strong points (and why):

    Het geheel

    Review:

    Meer details over het geheel van onder meer procesvalidaties. Binnen ons bedrijf doen we dit op een bepaalde manier en het is heel leerzaam hoe dit anders kan (vanuit een ervaren iemand uit de industrie, maar ook vanuit andere in de field).

    El Khamlichi - Apotheker productie

    4 out of 5 stars

    Strong points (and why):

    Systematische aanpak

    Dennis vd Vlies - QA specialist food

    4 out of 5 stars

    Strong points (and why):

    Roadmap voor gevalideerde processen

    Review:

    Goed om het overzicht duidelijk te maken voor de te doorlopen stappen bij een nieuw proces Goede interactiviteit. Het gegeven notitieblok heeft een te grote regelafstand. Mijn blok zat daardoor wat te snel vol.

    Robbert Kapoen - Productieapotheker

    3 out of 5 stars

    Strong points (and why):

    Cleaning validatie. Verbeterpunt in bedrijf.

    Review:

    Ik had gehoopt dat er voorbeelden uit de praktijk inhoudelijker aan bod zouden komen.

    Yvonne Siteur - QA Officer

    4 out of 5 stars

    Strong points (and why):

    Praktijk voorbeelden en hand-out documenten.

    Anoniem - QA Officer

    4 out of 5 stars

    Strong points (and why):

    Niet specifiek.

    Review:

    Prettige sfeer, fijn dat er ook aandacht was over hoe nu verder.

    Dorien van de Pol - Kwaliteitsmedewerker

    4 out of 5 stars

    Strong points (and why):

    Continu Verificatie, hier doen we nog weinig aan.

    Review:

    Dank je wel! Voorbeeld documentatie is heel waardevol.

    Martijn Luijten - Anonymous

    training image

    € 922.00 ex. VAT

    Registration ends in 339 days.

    Register now!

    The upcoming start date of this training is guaranteed.