PCS certificering voor Lead & Support auditors. Voor externe audits, interne en remote audits
Based on 405 participants
GMP & GDP training for pharma & biotech
€ 1729.00 ex. VAT
Registration ends in 113 days.
Register now!The upcoming start date of this training is guaranteed.
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
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.
Trainer
Pharmaceutical professional with over 40 years of expertise in the pharmaceutical industry, focusing on Quality Assu...
Trainer
Lecture | Day |
---|---|
Introduction of the course
|
1 |
Summary eLearning: Audit Preparation
|
1 |
Audits and (self)inspections from a regulatory perspective
Expectations from the GMP & GDP regulations
|
1 |
Mock Audit - Developing a suitable audit strategy and plan
|
1 |
Recording audit observations during the tour
|
1 |
Non-technical aspects of auditing
The Edict Model
The psychology of inspecting
Cultural Differences
The art of asking good questions
|
1 |
Closure of the day
|
1 |
Lecture | Day |
---|---|
Introduction day 2
|
2 |
Remote audits
|
2 |
How is quality made
|
2 |
Analysing audit findings & severity of audit observations
|
2 |
Writing Report
|
2 |
Mock audit – In-depth investigation
|
2 |
Audit tour in the warehouse
|
2 |
Auditing in your own practice
|
2 |
Closure
|
2 |
You will follow a 45-minute eLearning course. The eLearning will be sent to you in a timely fashion.
At the end of day 1, you will be offered a drink and a snack.
4 out of 5 stars
Based on 79 reviews
5 star reviews
4 star reviews
3 star reviews
2 star reviews
1 star reviews
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
€ 1729.00 ex. VAT
Registration ends in 113 days.
Register now!The upcoming start date of this training is guaranteed.
Download our training brochure for 2024 by clicking this link