External Audits & Self-inspections
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External Audits & Self-inspections

PCS certificering voor Lead & Support auditors. Voor externe audits, interne en remote audits

  • Based on 405 participants

GMP & GDP training for pharma & biotech

  • Language:
    Dutch flag
  • 2 days in total

€ 1729.00 ex. VAT

Registration ends in 133 days.

Register now!

The upcoming start date of this training is guaranteed.

This training contains:
  • Accreditation for ziekenhuisapothekers (NVZA), 12 accreditation points
  • Lunch
  • Digital copy of materials
  • Training certificate

    • What you will learn

    Optimally prepare, structure, manage and report the audit in a time-saving manner

    Effective communication with auditees, even in difficult situations

    Maintain a good relationship between auditor and auditee

    Training Dates

    Dates Language Price Register
    11/19/24 to 11/20/24 Dutch spoken language (primary) € 1729.00 Registration closed
    4/1/25 to 4/2/25 Dutch spoken language (primary) € 1729.00 Register
    11/11/25 to 11/12/25 Dutch spoken language (primary) € 1729.00 Register

    Description

    The Training

    A two-day training on external audits (suppliers and contractors), internal and remote audits. PCS certification for Lead & Support auditors.
     
    Effective auditing is not easy, every auditor has to deal with: extensive regulations, complex matter and auditees who do not simply accept observations.
    In this two-day course you will learn how to optimally prepare, structure, manage and report the audit in a time-saving manner and communicate effectively with auditees, even in difficult situations. We discuss external audits (suppliers and contractors), self-inspections and remote audits. 
     
    With optional final exam for PCS certification.

    Target Audience

    This training is intended for novice and experienced auditors who want to increase their impact during internal, external or remote audits. 

    It is assumed course participants already have GMP or GDP knowledge.

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

    Results

    • Ask effective questions
    • Being able to apply different audit techniques, with which you find the root cause of quality problems and get a picture of the quality culture in the organization
    • Effective and time-saving auditing

    Contents

    Take the basic theory of Audit Preparation online in advance at a location and time of your choice (45 min), followed by a two-day on-site training.
    1. Audit preparation and planning
    2. Types of audits and qualifications (incl. suppliers)
    3. Audit techniques (including risk-based and rapid auditing)
    4. In-depth research
    5. Recording observations during the tour
    6. Communicate effectively
    7. Reporting
    8. Current topics, such as Data Integrity

    Lecturers

    René Maassen avatar

    René Maassen

    Trainer

    Pharmaceutical professional with over 40 years of expertise in the pharmaceutical industry, focusing on Quality Assu...

    Jolanda Muurman avatar

    Jolanda Muurman

    Trainer

    Program

    Practical Information

    Accreditation:
    Difficulty / Level:
    Intermediate 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
    Requires preparation:
    Yes.

    You will follow a 45-minute eLearning course. The eLearning will be sent to you in a timely fashion.

    Includes exam:
    Yes.
    Exam price:
    €250.00 ex. VAT per participant.
    Networking event with drinks:

    At the end of day 1, you will be offered a drink and a snack.

    Tags

    GMP GDP EudraLex Volume IV Quality Assurance Qualification Quality Culture Manufacturing Distribution QMS Trending Self Inspection Auditing Mock Audit Audit Plan Observations Remote Auditing

    Reviews (79)

    4 out of 5 stars

    Based on 79 reviews

    Review data

    5 star reviews

    38%

    4 star reviews

    52%

    3 star reviews

    10%

    2 star reviews

    0%

    1 star reviews

    0%

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

    5 out of 5 stars

    Strong points (and why):

    Leuk! Vooral de combinatie luisteren en acties uitvoeren.

    Review:

    Ga zo door

    Laura roos - Cleanroom coördinator

    4 out of 5 stars

    Strong points (and why):

    Veel voorbeelden

    Review:

    Wel veel info in 2 dagen

    Robert van Grieken - QA

    4 out of 5 stars

    Strong points (and why):

    Duidelijke uitleg, trainers met veel kennis

    Review:

    Iets meer aandacht voor zelf inspectie of anders de trainingen loskoppelen

    RvBodegraven - RP/QA manager

    4 out of 5 stars

    Strong points (and why):

    Goede inhoudelijke kennis. Afwisseling in presentaties en interactieve workshops

    Suzanne Robben-Faassen - QA Officer Pharmaceuticals

    4 out of 5 stars

    Strong points (and why):

    Een goede basisvorming

    Rachida - Manager QAS

    4 out of 5 stars

    Strong points (and why):

    Variatie

    To be improved:

    Nee

    Review:

    Goede en leuke wijze

    Anonymous - Anonymous

    5 out of 5 stars

    Strong points (and why):

    Goede uitleg met veel voorbeelden maar ook heel interactief met mini workshops die heel leerzaam waren.

    Review:

    Ik wil jullie bedanken voor deze training, complimenten voor de inhoud, het organiseren en het faciliteren, ik ben heel tevreden en ik heb veel geleerd en ook achtergekomen waar ik echt aan moet werken!

    Carolina - Quality Specialist

    5 out of 5 stars

    Strong points (and why):

    Relevante onderwerpen, kennis vd trainers

    Thu - QA officer, Apotheker

    4 out of 5 stars

    Strong points (and why):

    Goeie sfeer en veel relevante kennis

    Eugene - Analist SA

    4 out of 5 stars

    Strong points (and why):

    De afwisseling van onderwerpen en de manier hoe het uitgelegd werd

    Natalia Perez De Boni - QUALITY SPECIALIST & RP

    5 out of 5 stars

    Strong points (and why):

    Ik vond alle onderwerpen zinvol voor mij. Aangezien ik slechts 1x een interne audit heb meegelopen.

    Anonymous - Anonymous

    4 out of 5 stars

    Strong points (and why):

    Pre wrap en rapporteren. Das een zwak punt bij ons.

    Review:

    Hartelijk bedankt

    Anonymous - Anonymous

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    Registration ends in 133 days.

    Register now!

    The upcoming start date of this training is guaranteed.

    Difficulty:
    Intermediate level
    This training contains:
  • Accreditation for ziekenhuisapothekers (NVZA), 12 accreditation points
  • Lunch
  • Digital copy of materials
  • Training certificate
    • Training 5 persons or more?

    In-house training may be the best option for you! We have over 100 GxP in-house training courses.

    In-house training