External Audits & Self-inspections

4.5 rating based on 405 ratings. 405 students

External Audits & Self-inspections

PCS certificering voor Lead & Support auditors. Voor externe audits (leveranciers en contractnemers), interne en remote audits

4.5 rating based on 405 ratings. 405 students

GMP & GDP training for pharma & biotech

Language(s):

2 days in total

€ 1.729 ex. VAT

Registration ends in 51 days.

Register Now Download Brochure

The upcoming start date of this training is guaranteed.

What you'll 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

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
Course content

Program - Day 1
Program - Day 2
LectureDay
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
LectureDay
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

Course dates

Start dateEnd dateVenuePriceStatus
14-11-202315-11-2023Hotel Mitland€ 1.729 ex. VATRegister
16-04-202417-04-2024Van der Valk Breukelen€ 1.729 ex. VATRegister
19-11-202420-11-2024Van der Valk Breukelen€ 1.729 ex. VATRegister

Language

  • Dutch spoken language

General information

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

14-11-2023

Hotel Mitland

Register

16-04-2024

Van der Valk Breukelen

Register

19-11-2024

Van der Valk Breukelen

Register

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
External Audits & Self-inspections thumbnail
€ 1.729 ex. VAT

Registration ends in 51 days.

Register Now Download Brochure

The upcoming start date of this training is guaranteed.

This training includes:

Training certificate

Lunch buffet

17 Lectures

Training 5 people or more?

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