Audit-kurs
 

Audit-kurs

 
PHARMACEUTICAL GMP AUDITS AND SELF-INSPECTIONS


Kurset ble for første gang i Norge gjennomført med stor suksess, mai 2017. Evalueringen gav en score på 4,73 av totalt 5.0, og alle deltagerne bestod eksamen! NFS vurderer å sette det opp igjen i 2019. Ved interesse ta kontakt på post@nfs.no.



Norsk Farmasøytisk Selskap tilbyr et 5 dagers Audit-kurs i Oslo i samarbeid med NSF-DBA Ltd (David Begg Associates) som avsluttes med en eksamen. Se internettsiden til NSF-DBA Ltd HER.

Se en film om kurset HER


                     

                     

                                                 



Tid
8.-12. mai 2017

Sted
Thon Conference Universitetsgaten


Kursavgift
Kr 35 000
Early bird -10% (kr 31 500), ved påmelding til og med 28. februar 2017


Antall kursplasser
20 stk
 

Påmelding
Send påmeldingsskjemaet ferdig utfylt til post@nfs.no innen 1. mai 2017.
Påmeldingen er bindende.


Overnatting
Det er reservert 10 superiorrom (til standardrompris) i Thon Hotel Slottsparken. Disse kan reserves frem til 08.04.2017 mot at du sender inn en e-post til slottsparken.booking@thonhotels.no og henviser til bestillingskode 24593525. Pris per natt er 1495,- NOK og inkluderer frokost.

Reservasjoner som gjøres via internett eller andre kanaler, og i ettertid henvises til denne bestillingskoden, får ikke den oppgitte spesialpris – da er det prisen som er booket og bekreftet som gjelder.

De som bestiller må oppgi følgende informasjon:
- Fullt fornavn og etternavn
- Telefonnummer
- E-postadresse
- Gateadresse, samt postnummer


Se brosjyren for kurset HER

Se programmet HER



Kurset kvalifiserer til 34,5 FEVU poeng (Farmasøytisk Etter- og VidereUtdanning)




Kursholdere er Liz Allanson og Darren Jones fra NSF-DBA Ltd., og kurset avholdes derfor på engelsk.



Kurset er strengt kalkulert, og det trengs 18 deltagere for å arrangere kurset som kun tar 20 totalt. NFS forbeholder seg retten til å avlyse kurset hvis det ikke skulle bli nok deltagere.




Kursinnhold
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?

Contents
• 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
• Contract manufacturing organisations
• 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.




Kommentarer fra tidligere kursdeltagere:

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

The overall information and presentation was extremely useful. Will recommend course to lots of friends.
Constantine Nkafu, Martindale Pharma

My attendance at this course will help convince our auditors that I am suitably qualified to perform audits (both suppliers and self-inspection).
Kenny Cowan, Norbrook Laboratories Ltd

Really good professionals at DBA. Thanks for sharing your knowledge/expertise with us!
Ervin Cuprill, F Hoffman-La-Roche

Extensive course notes and excellent lectures given by knowledgeable and professional tutors who were very easy to approach with any problems during the course.
Amjeid Saddique, Herd Mundy Richardson

Course materials were extensive. Tutors were very open and extremely knowledgeable.
Maliga Chetty, Adcock Ingram Healthcare

Gave me a different view on auditing. Very good course!
Martin van Rooyen, Johnson & Johnson Medical (Pty) Ltd.

Excellent course materials and tutors. Gives me confidence to perform audits, as a first time auditor.
Geeta Ghela, Afrika Biopharma Manufacturing (Pty) Ltd

What a pleasure to attend a course of this calibre - it is most appreciated and many thanks.
Derek Silberblatt, Aspen Pharmacare East London (Pty) Ltd

Found the course excellent. Very informative. Realistic hands on information. Interaction and group kept me focused. Speakers very well informed and able to impart their knowledge successfully (even succeeded in making me feel slightly confident even though I have no experience).
Carla Silva, B Braun Medical (Pty) Ltd

Very useful for a newcomer to the field of auditing. The buzz groups and role play were very helpful. Both presenters/tutors were excellent in their presentation of the topics, with genuine examples. Obvious that they both are experienced in this field/subject matter!
Shivani Patel, Merck (Pty) Ltd

Thank you for a great time. The training was great, very professional, well planned and well delivered. Thank you again.
Aga Sufin, Novartis Grimsby Ltd


Excellent content and organisation. Good mix of lectures, activity sessions and sharing of real life experiences. Very useful role play sessions.
Sue Marlow, Patheon UK Limited

Tutors ran the course at a good pace with lots of interaction which helped in focusing on the material and retaining the information.
Adam Hughes, Baxter Healthcare

One of the best training courses I have ever been to!! The mix of lectures, teamwork and presentations was very good and gave a lot of opportunities to practice and discuss with other participants. Very competent trainers.
Kicki Garhedenn Fredriksson, Octapharma AB, Sweden

I have benefitted from the course content and syllabus but more importantly from the profound experience and valuable anecdotes and examples from the three tutors.
Poh Ewe Tan, Roche Singapore Technical Operations, Singapore

Got exactly the essential information and training I needed - can't wait to use it!
Alan Sarup, Orifarm Generics A/S, Denmark

Excellent content and lectures as usual.
Chris Unwin, Dr Reddys Laboratories (UK) Ltd

The tutors are very professional! I enjoyed learning from them and their experiences! Thank you!!! Although the course was very intensive I will recommend it to my colleagues.
Chen Friedlis, Dexcel Pharma, Israel

I would strongly recommend this course to anyone who performs pharmaceutical compliance auditing, from the novice to the experienced professional. The success of a course such as this relies on how it is structured and the abilities of the instructors. I was very impressed with the instructors, their presentation and interpersonal skills were especially good.
Paul J Siciliano, Patheon Pharmaceutical Services Inc, USA

Tutors were excellent. The buzz groups were very helpful. Good opportunity to exchange ideas. The mock audit was very helpful.
Emmanuel (Manny) Bennett, Takeda Global R&D, USA

This is the best auditing course I've ever taken! I loved the exercises to actually apply the information. Neil and Mike are fantastic instructors! They covered all of the material in a manner that demonstrated their vast experience and passion for auditing. Most importantly their commitment to patient safety. I would highly recommend this course to any auditor – old or new. I learned a lot and I also have greater confidence in my auditing skills. I'm exhausted but I loved it.
Tanisha McClendon, Biogen Idec, USA

The tutors were very competent! The class set up and buzz groups were very effective.
Stephen Muturi, Pharmalucence, USA



Intense and challenging but brilliant. Very interactive and good atmosphere (great people). Set at a level for all levels of experience. Has given me the knowledge and confidence to start auditing. Increased my interest in auditing. Presented extremely well with very knowledgeable tutors.
Kate Waterhouse, Napp Pharmaceuticals, UK

From my point of view this course is excellent, the content, the tutors. I would really recommend to others in this area. I have learned things which are useful and applicable to my area.
Miriam Ebrahimi, Shire, Sweden

The days were long and tiring but a fantastic interactive course. Another superb course from NSF-DBA, fabulously delivered by 2 experts with vast experience. Thanks for sharing your auditing stories.
Andrew Gravett, AstraZeneca, UK

Excellent course, very happy! I had very little experience of auditing, course has given me a lot of knowledge/confidence - excellent tutors and very interactive.
Ruminder Randhawa, Napp Pharmaceuticals, UK

High quality course. I learned a lot and feel much more comfortable concerning auditing/standards/regulations used, techniques, knowledge.
Nicola Dietmann, F.Hoffmann-La Roche Ltd, Switzerland

Tutors were approachable, patient, open, but also ensured we were challenged to justify/understand our opinions/comments.
Caroline Clark, Merck Sharp & Dohme Ltd, UK

Very well structured. Excellent lectures. Excellent tutors. Everything started making sense. Will strongly recommend. Very encouraging. A*
Ewa Franus, PharmaQ Ltd, UK

Really tough course but very worthwhile.
Peter Cormack, AstraZeneca Pharmaceuticals, UK

The course was very organised and structured. The tutors gave really good examples of all subjects. They challenged you to stay focused during the interactive sessions and lectures. I have learned a lot during this course.
Thera Lardinois-Garritsen, Pharmacell BV, The Netherlands

Excellent course. Very comprehensive but well structured to keep the content interesting and participants involved.
Lee Bromley, Shire Pharmaceuticals Devt Ltd, UK