Public-registration training
External Audits & Self-inspections
PCS certification for Lead & Support auditors. For external audits (suppliers & contract acceptors), internal and remote audits
External Audits & Self-inspections
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
Dutch spoken language
The training
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
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
- Audit preparation and planning
- Types of audits and qualifications (incl. suppliers)
- Audit techniques (including risk-based and rapid auditing)
- In-depth research
- Recording observations during the tour
- Communicate effectively
- Reporting
- Current topics, such as Data Integrity
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.
| Lecture | Sub-lectures |
|---|
| Lecture | Sub-lectures | Day |
|---|---|---|
| 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 |
| Lecture | Sub-lectures | Day |
|---|---|---|
| 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 |
| Start date | End date | Venue | Price | Status |
|---|---|---|---|---|
| 04-04-2023 | 05-04-2023 | Van der Valk Breukelen | € 1.729 ex. VAT | Open for registration |
| 14-11-2023 | 15-11-2023 | Hotel Mitland | € 1.729 ex. VAT | Open for registration |
Karen Zimmermann
Senior GMP/GDP Trainer & Consultant
René Maassen
Senior GMP/GDP Trainer & Consultant
Karen Zimmermann
René Maassen
To start your registration, first select the start date of the training, then fill in the form below.
Register now!
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| Times: | The course starts at 9:30 am and ends at 5:30 pm | ||||||||||
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€ 1.729 ex. VAT
Training certificate
Lunch buffet
17 Lectures
An in-house training is your best choice! We have more than 100 GxP in-house training courses on request.
