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 group 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 new 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.
What you've said
The NSF-DBA ‘Effective Pharmaceutical Audits and Self-Inspections’ course is viewed as one of our most favoured and successful courses. So far over 270 people have taken or booked this course since the pilot course was first run in mid 2011 and we have acheived a 95% success rate at the exam stage
“I have learned a lot, and the book was informative. I will apply this in my work situation.”
Godfrey Radebe, Johnson & Johnson Medical, SA
“Very enjoyable and knowledgeable tutors.”
Wilma Vergeer, The Biovac Institute, SA
“The course was very informative. The content of the course will assist in auditing in the future.”
Momeena Omarjee, National Bioproducts Institute, SA
“Course materials were extensive. Tutors were very open and extremely knowledgeable.”
Maliga Chetty, Adcock Ingram Healthcare, SA
“The course helped me understand how to conduct myself in an audit. It also helped me understand the key elements of auditing. I am now able to gain insight into auditors who will audit me.”
Ursila Singh, Resmed Healthcare, SA
“Gave me a different view on auditing. Very good course!”
Martin van Rooyen, Johnson & Johnson Medical, SA
“Excellent course materials and tutors. Gives me confidence to perform audits, as a first time auditor.”
Geeta Ghela, Afrika Biopharma Manufacturing, SA
“What a pleasure to attend a course of this calibre – it is most appreciated and many thanks.”
Derek Silberblatt, Aspen Pharmacare East London, SA
“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, SA
“This is an excellent course, thanks! As a completely ignorant person in the auditing field it was a bit overpowering with an overload of information. HOWEVER after the four days I have a much better understanding of audits.”
Marianna Hayes, Ranbaxy, SA
“Really appreciated the practical approach and examples – for numerous cases a very worthwhile course.”
Jean Morgan, Reckitt Benckiser Pharmaceuticals, UK
“Thank you!”
Lizette Wittstock, Aspen Pharmacare East London, SA
“The examples used illustrated the point well.”
Desiree Chinnian, Pfizer Laboratories, SA
“Very useful to a newcomer to the filed 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, SA
“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 
