About this course
In the last year alone we have seen further significant changes and additions to pharmaceutical legislation and guidelines that will all have a major impact on how we do business - these include:
- FDASIA (Food and Drug Safety and Innovation Act) in the USA
- Further enabling and clarification of the FMD (Falsified Medicines Directive) in Europe
- Updated GMP guidelines that reflect the increasing impact and implementation of ICH Q10 (Pharmaceutical Quality System)
- Draft guideline from the EC on GMP Risk Assessment for Excipients
And there will be more to come…
The success of your company in meeting current expectations will depend significantly on the quality of your audit and self-inspection system, and in the competence, professionalism and decision making of your auditors.
This is the first truly independently certified pharmaceutical GMP auditor course available across Europe, and now globally.
Pressure on the pharmaceutical industry to audit has never been higher and continues to increase. Supply chain decisions and batch release decisions are being made based on audits and self-inspections. As a result, a high level of scrutiny is being placed on the training and development of auditors and self-inspectors.
Decisions are being made covering:
- Approval of suppliers
- Approval of contractors
- Acceptability of in-house practices and procedures
- Overall regulatory compliance status
Auditor skill and competency are critical to making the right decisions. This course will provide education, training and development for auditors to meet these continuing pressures and fulfil this critical role.
The NSF-DBA ‘Effective Pharmaceutical Audits and Self-Inspections’ course is viewed by past delegates as one of our most favoured and successful courses.
Faced with industry and regulatory pressure, NSF-DBA was actively encouraged to successfully redesign an existing, popular course and reintroduce it with a new qualification for pharmaceutical Good Manufacturing Practices (GMP) lead auditors. The course, certified by IRCA (www.irca.org), the world’s largest international certification body for auditors of quality management systems, meets the training requirements of the Pharmaceutical Quality Management Systems Auditor/Lead Auditor course. This course has been specifically designed to provide delegates with education, training and development to meet today’s pharmaceutical pressures, including the auditor skills and toolbox of auditing techniques needed by the successful pharmaceutical lead auditor. Given the course focus, content and delivery of EudraLex Volume 4 Chapters 1 to 9 and ICH Q10 as the combined QMS, the team at NSF-DBA sees this as the first truly certified GMP auditor training course available globally today.
What You Will Learn
- The difference between an average auditor and a great auditor
- How to structure, plan and manage an audit and self-inspection programme or system
- How to use risk assessment to set audit priorities and rank observations
- How to use and develop the auditor’s technical and non-technical skills, competencies and personal attributes to provide a toolkit of key auditing skills
- Technical guidance through current hot topics from years of top level audit experience
- Effective questioning techniques
- Reviewing data
- Techniques used to train inspectors from world renowned regulators
- How to prepare for and conduct your best audit ever
Who Should Attend
- Anyone involved in the management and conduct of internal and external audits and self-inspections
- Those who have to face auditors and want to be aware of the processes and techniques being applied
- This will include:
- Qualified Persons
- Auditors old and new
- Quality Assurance
- Self-inspectors
Certification
This course meets the training requirements for the new IRCA (www.irca.org) Certification of Pharmaceutical Quality Management Systems Auditor/Lead Auditor (PQMS). IRCA course certification number: A17638
The course is highly interactive and takes the form of a mock or virtual audit. Additionally, discussion periods, including a course tutor panel session, provide delegates with an opportunity to obtain answers to their specific questions and concerns.
Course outline
- The course assumes experience and working knowledge of GMP guidelines in the region the auditor is working (EudraLex Volume 4 or US CFR 21), or previous attendance at an NSF-DBA four-day Pharmaceutical GMP course
- The course follows ISO 19011 guidelines for quality and management systems auditing
- The course is prepared using pharmaceutical industry standards including:
- ISO 900
- IPEC guides
- PS 9000
- GMP
- Industry Standards of ICH
with special emphasis on the Quality Management System and ICH Q10
Principles and audit planning
- Planning and preparation
- Audit types and techniques
- Establishing an audit programme for suppliers, contractors and company sites
- Internal vs external audits
- The audit process
Auditor skills and competencies
- What makes a good auditor
- Communication skills – questioning and listening
- Body language and non-verbal communication
- Overcoming apathy, resistance and aggression
- Effective note taking
- Auditor continuing professional development
- Assessing the auditor
Initiating, preparing and conducting the audit
- Materials management
- Documentation systems
- Sterile products
- Oral solid dose
- Packaging
- Laboratories
and many more
Concluding the audit
Discussion and Working Groups
A significant proportion of the course time will be devoted to group work, where delegates have the opportunity, through case studies, to put them into practice. Additionally, individually assigned tutors will provide delegates with an opportunity to obtain answers to their specific questions and concerns, providing maximum opportunity for success on the course.
The course includes an IRCA assessment exam. Our current pass rate is in the region of 95% +. Free support and re-sits are available within 12 months of the exam date for those few who may need the help.
Venue
Renaissance Manchester City Centre Hotel, Manchester, UK
Located in one of the most exciting cities in UK, the 4 star Renaissance Manchester Hotel is at the heart of Manchester’s entertainment quarter. The hotel features one of the largest conference venues in the city which also provides wireless internet access.
The hotel offers spacious bedrooms with air conditioning, lounge area, excellent workspace and WIFI access.
Hotel Accommodation
- Online early booking offer – we have negotiated a discounted bed and breakfast rate including free wi-fi.
- To take advantage of this offer, you must book via a special weblink, details of which are provided under the ‘Hotel Bookings’ section at the bottom of this page.
- This offer is only available until four weeks before the course start date, after which point the hotel cannot guarantee room or rate availability.
- If you need any help or guidance with the accommodation booking process, please contact our course administration team.
- Your account with the hotel should be settled at check-out.
- Any charges made by the hotel as a result of you not taking up your reservation for any reason will remain your responsibility, therefore please ensure you are aware of the hotel’s cancellation policy.
Venue Address and Contact Details
Renaissance Manchester City Centre Hotel
Blackfriars Street
Manchester
M3 2EQ
England
Tel: +44 (0) 1618 316 000
Fax: +44 (0) 1618 353 077
www.marriott.co.uk
Hotel Bookings
If you would like to benefit from our specially negotiated Bed and Breakfast rate with the hotel, please book your accommodation following this link
This offer is only available until four weeks before the course start date, after which point the hotel cannot guarantee room or rate availability.
Tutors
All our presenters have extensive industrial and, in some cases, regulatory agency experience. We are fully up-to-date with the very latest international regulatory and GMP compliance requirements and we have the experience to help you meet the challenges of auditing diverse topics and facilities in the pharmaceutical arena.
Our experts for this course are:
What you've said
“Very good course with a great depth into the audit process, It will give me more confidence to be able to act as a head auditor in a professional way.”
Natasja Jacobs, Abbott Logistics, The Netherlands
“Besides auditing skills a good overall impression of the quality management system. Thank you!”
Gert-Jan van Diest, Abbott, The Netherlands
“This course was very interactive with numerous concrete examples.”
Florence Kapp, Celgene International, Switzerland
“Good, interactive. Beneficial, efforts by tutors appreciable. Course materials well designed for the objective.”
Kareen Shakir Usain, Al Qusais, United Arab Emirates
“I feel much more confident to carry out an audit having attended this course.”
Jon Steingrimsson, Genzyme Biosurgery, Denmark
“Very informative with depth of subject knowledge and great two way communications on each subject/lecture.”
Nitesh Nayak, Missionpharma Logistics, India
“A lot better understanding of ICH Q10! Overall understanding of auditing process is now a lot better. This course indicated clearly on which areas I personally need to improve.”
Paivi Waris, Santen, Finland
“An excellent course with well-presented material by highly knowledgeable tutors. The opportunity to take part in a mock audit closing meeting was extremely valuable.”
Matthew Scarff, Rosemont Pharmaceuticals, UK
“Very pleasant, intensive course in a nice open atmosphere. Learnt a lot, very enthusiastic.”
José Houtman, Allione Consultancy, The Netherlands
“The chance to learn from very experienced tutors is very, very, valuable! Excellent experience.”
Richard Anspach, Aluglas, The Netherlands
“A really excellent course! It was one of my most active and intensive weeks but I do not regret it at all.”
Tomasz Zawislak, Pharmatiqa Consultants, Poland
“Excellent content and organisation. Good mixture of lectures, activity sessions and sharing of real life experiences. Very useful role play sessions.”
Sue Marlow, Patheon, UK
“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, UK
“Tutors have excellent knowledge. Good mix of lectures and activities.”
Chirag Patel, Amdipharm, UK
“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, 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, Denmark
“Excellent content and lectures as usual.”
Chris Unwin, Dr Reddys Laboratories, UK
“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, USA
“Tutors were excellent. The buzz groups were very helpful. Good opportunity to exchange ideas. The mock audit was very helpful.”
Emmanuel 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 also have greater confidence in my auditing skills. I’m exhausted but I loved it.”
Tanisha McClendon, Biogen Idec, USA
“Excellent! Well delivered! Neil and Mike were very animated. Good humour and kept it fun.”
Jeff Moore, Genetech, USA
An NSF International Company 
