Public-registration training

External Audits & Self-inspections

4.5 rating based on 405 ratings 4.5 rating based on 405 ratings.
PCS certification for Lead & Support auditors. For external audits (suppliers & contract acceptors), internal and remote audits

This training includes:

Upcoming edition starts 04-04-2023

External Audits & Self-inspections

PCS certification for Lead & Support auditors. For external audits (suppliers & contract acceptors), internal and remote audits

4.5 rating based on 405 ratings 4.5 rating based on 405 ratings.

2 days in total
405 students
Upcoming edition starts 04-04-2023

External Audits & Self-inspections

What you will learn

Effective communication with auditees, even in difficult situations

Maintaining a good relationship between auditor and auditee

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

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Training language(s)

  • Dutch spoken language

Training 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 group

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.

Learning objectives

  • 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

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.

Content

Take the basic theory of Audit Preparation online in advance at a location and time of your choice (1 hour), 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

Training program

17 lectures in total. The program is subject to change. The final program will be sent to the participants approximately 1 week before the start of the training. No rights can be derived from this program.

Program - eLearning Component
LectureSub-lectures
Program - Day 1
LectureSub-lecturesDay
Introduction of the course

  • Introduction
  • Learning objectives
  • 1
    Summary eLearning: Audit Preparation

  • Summary eLearning: Audit Preparation
  • 1
    Audits and (self)inspections from a regulatory perspective

  • Audits & (Self-)inspections from a regulatory perspective
  • 1
    Expectations from the GMP & GDP regulatory perspective

  • Expectations from a GMP & GDP regulatory perspective
  • Awareness of Quality Culture and your role as auditor
  • 1
    Mock Audit - Developing a suitable audit strategy and plan

  • Mock Audit - Developing a suitable audit strategy and plan
  • 1
    Recording audit observations during the tour

  • Recording audit observations during the tour
  • 1
    Non-technical aspects of auditing

  • The Edict Model
  • The psychology of inspecting
  • The art of asking good questions
  • 1
    Closure of the day

  • Closure of the day
  • 1
    Program - Day 2
    LectureSub-lecturesDay
    Introduction day 2

  • Introduction day 2
  • 2
    Remote audits

  • Remote audits
  • 2
    Analysing audit findings & severity of observations

  • Analysing audit findings & severity of audit observations
  • 2
    Report writing

  • Report writing
  • Small workshop
  • 2
    Mock audit – In-depth research

  • Mockaudit – In-depth investigation
  • 2
    Audit tour in the warehouse

  • Audit tour in the warehouse
  • 2
    Auditing in your own practice

  • Auditing in your own practice
  • 2
    Closure

    2
    Exam

    2

    Training date(s)

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    Lecturer(s)

    Registration

    To start your registration, first select the start date of the training, then fill in the form below.

    Upon passing the exam, you will receive a Certificate of Competence. The exam is optional.

    Participants
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    General information

    Learning form:Classroom
    Times:The course starts at 9:30 am and ends at 5:30 pm
    Venue(s):
    Start dateVenueRegister

    04-04-2023

    Van der Valk Breukelen

    Register

    14-11-2023

    Hotel Mitland

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    Preparation:
    Preparation required:Yes
    Preparation details:eLearning 45 min
    Exam:
    Includes exam:Yes
    Exam optional:Yes
    Re-examination possible:Yes
    Exam fee in course price:No
    Examination fee for each exam attempt:250

    Register now!

    Register for this training by clicking the button.