Audit-kurs

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Pharmaceutical GMP Audits and self-inspections

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:

Delegate feedback:

Good material support, good ‘calibration’, important hints from experts. Very good organisation, I really liked the structure that was equivalent to an audit.
Ricardo Cespedes, Celgene International
Although intensive, this course was perfect for delegates like myself with knowledge of GMP but limited audit experience. The buzz groups were excellent and interaction with both delegates and tutors was very beneficial.
Ian Morgan, Aeropak Chemical Products Ltd
Excellent course, materials and tutors. Surpassed my expectations. Thanks!
Barry Cook, Sanofi-Aventis Pharma
Very good tutors with extremely highly level of knowledge. Thank you for that fantastic training.
Kathrin Haberstroh, Roche
Excellent course and tutors. Useful tips and information on conducting audits and handling auditees.
Kathryn Fraser – Dales Pharmaceuticals
Very professional and passionate motivated tutors – go on like this in the future!
Anon
Thank you for sharing with us your knowledge and your brilliant way of thinking.
Eleonora Casucci, Astellas Pharma Europe BV
It was very helpful to come into auditing business. Now I can feel much much more confident in taking part in an audit as auditor and later on as lead auditor. Now I am really looking forward for the times to perform an audit.
Antje Rudolph, F Hoffman-La-Roche
Excellent course, good fun while delivering the knowledge in an effective and interactive way.
Martin Bannon, Warner Chilcott
Excellent tutors, with a vast range of knowledge and experience. Very informative course.
Margaret Rushe, Abbott Ireland Pharmaceutical Operations

About the course

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:

Eudralex Volume 4 Part 1 Chapters 1-9
ICH Q9
ICH Q10
GDP Guidelines for medicinal products (2013/C 343/01)

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?

Audit Scene Setting
The Company Audit System (including The Regulatory Perspective) Different Types of Audit
Introduction to ICH Q8/Q9/Q10 and Q9 Quality Risk Management
Exam and Certification Process Briefing
The Difference between External Audits and Internal Audits
The Audit Process
Auditing the Audit System
Evaluating the Audit System
Introduction to Terminology
PIC/S, EU, FDA Audit Standards and Procedures
Technical Standards and Guidelines
Other Standards
The Principles of Auditing
What Makes a Good Auditor?
Auditor Competencies and Roles
Communication Skills
Cultural Differences and Body Language
Evaluating the Auditor
Developing and Using Aide-Mémoires
Other Useful Techniques and Advice
Introduction to Systems Auditing
Quality Management Systems Audits – What to Look For?
ICH Q10 Pharmaceutical Quality Systems
The Detailed Planning of the Audit
Gathering Information
Selecting the Team
Audit Logistics
Create an Audit Plan
Introductory Meeting
Auditing Materials Management
Auditing the QMS (ICH Q10) and Elements of the QMS
Ranking the QMS Observations
Topics of Choice
Writing Audit Observations
The Close-Out Meeting
Sharing Best Practice on Report Writing
Preparation for Close-Out Meeting Role Play
Audit Follow Up
New Developments for Auditors
Final Questions and Answers

How Will I Be Assessed and What Can I Get From The Course?

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.

In addition:
• 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.

Who Is This Course Designed For?

Auditors assessing:

Dosage form manufacturers
Pharmaceutical back office operators
API suppliers
Excipient suppliers
Packing component suppliers

These auditors could be:

Qualified Persons
Quality assurance
Self-inspectors from QA and operations teams
Virtual companies
Quality Unit staff

Will I Be Able To Do This Course?

Course and exam language – English (other language variants are in development)

Prior knowledge:

You will be expected to have a working knowledge of ideally 3 – 5 years or have attended the NSF Health Sciences 4 day GMP course
EudraLex Volume 4 Chapter 1-9 Or CFR 210/211
Have read ICH Q8, Q9, Q10
Ideally have read ISO 19011, although working copies are provided on the course

If in doubt about your knowledge and experience do contact Sarah Richardson (asipharma@nsf.org).

Will I Have to Present On The Course?

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.