Kurset ble for første gang i Norge gjennomført med stor suksess i mai 2017, og deretter i mai 2019. Evalueringen gav en score på 4,73 av totalt 5.0, og alle deltagerne bestod eksamen! NFS tilbyr kurset på nytt i mai i 2023, og har heretter planer om å tilby kurset hvert annet år, ved behov.
5 dagers Audit-kurs i Oslo i samarbeid med NSF Health Sciences (tidligere David Begg Associates) som avsluttes med en eksamen. Se internettsiden til NSF Health Sciences.
Kurset avholdes i sin helhet på engelsk.
Hør hva Thi Truc Nguyen sier om kurset:
For many years, the only internationally recognised qualification a pharmaceutical auditor could get, was ISO 9001 Lead Auditor certification. This did not apply or recognise the specific GMP/GDP standard that is legally required when dealing with pharmaceutical operations. In 2012 NSF/DBA launched a Pharmaceutical Quality System Lead Auditor Course independently approved by The International Register of Certificated Auditors (IRCA). Completion of this course now allows pharmaceutical auditors to apply for IRCA certification as a Pharmaceutical Auditor.
This course aims to give the students the knowledge, tools and practical skills to audit in a Pharmaceutical GMP/GDP legislated environment
With the current complexity of the pharmaceutical supply chains, there has been an increasing Regulatory focus on the quality of audits performed of manufacturers, suppliers and distributors in these supply chains and also on the skills, experience and training of the auditors.
Pharmaceutical auditors need to demonstrate to regulators and to employers that they can effectively audit the Pharmaceutical Quality System applied in a GMP and GDP environment. This course and subsequent IRCA certification allows them to do this.
In order to apply for a place on this course, students must already have knowledge of the standard that they audit to. This is GMP and GDP as defined in Eudralex or PICS. If students are in the EU or EEA they must be familiar with:
The course can accept a maximum of 20 attendees and provides an opportunity to practice those all- important auditors skills in a friendly and fun environment.
The course is designed to give the auditor the techniques and awareness of skills that it has taken many experienced auditors decades to develop.
The course follows the auditing guidance of ISO 19011. The course is a virtual audit of a manufacturing facility making a range of dosage forms and allows the participants to plan and prepare their audits of the supplier and of their own supplier audit system. There is personal practice throughout with exercises and teamworks in planning, preparation and performance from the question of who do we audit, why do we audit and how do we audit?
You will receive the best possible training from industry experts – from tutors expert in training techniques who each have 20 to 40 years experience in the pharmaceutical industry, having conducted 100s of audits.
• Take the course and pass the continuous assessment
• Meets training requirements for → internal auditor
• Take the course and pass the end of course assessment exam
• Meets training requirements for → automatic certification as a provisional auditor (with appropriate education background)
• Meets training requirements for → pharmaceutical GMP lead auditor
With appropriate audit experience can become a certified pharmaceutical GMP lead auditor.
Course and exam language – English (other language variants are in development)
If in doubt about your knowledge and experience do contact Sarah Richardson (firstname.lastname@example.org).
The course is designed to simulate the roles auditors face when auditing; there will be groupwork, working solo and some feedback to the group of up to 20 trainee auditors.