About this course
This is the first truly independently certified pharmaceutical GMP auditor course, available now globally.
Supply chain assurance is the key topic in our industry today. From starting material to patient, pharmaceutical companies are expected to be able to demonstrate control. Increasingly that means audit or justify why not!
Regulators’ expectations for the quality of audits and their work continue to increase. This course will prepare you to perform your best audit ever. During 2014 we expect to reach our 500th trained auditor in this new challenging and
demanding course.
What You Will Learn
- You will develop a toolbox of auditor skills from planning to execution and follow-up.
Certification
This course meets the training requirements for the recently introduced IRCA (www.irca.org) Certification of Pharmaceutical Quality Management Systems Auditor and Lead Auditor (PQMS). Satisfactory completion of the course exam and post course audit experience are required to gain certification.
The course is highly interactive and takes the form of a mock or virtual audit, using real pharmaceutical case studies.
Additionally, discussion periods, including a course tutor panel session, provide delegates with an opportunity to obtain answers to their specific questions and concerns.
Continuing Education Credit
‘Effective Pharmaceutical Audits and Self-Inspections’ offers Pharmacists knowledge learning which will provide an understanding of skills, knowledge and process for conducting audits.
ACPE Continuing Education Units = 3.2
Reference Activity Number = 0616-0000-12-001-L04-P
Course outline
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 9000
- 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
For further information, please contact Kate Principe by telephone 857-350-4811, or email [email protected]
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 theory into practice.
Additionally, discussion periods, including a course tutor panel session, provide delegates with an opportunity to obtain answers to their specific questions and concerns.
Venue
Boston Marriott Cambridge, Cambridge, MA, USA
The Boston Marriott Cambridge is situated across the Charles River from downtown Boston and is the perfect location for your next visit to the city. This Cambridge hotel is positioned in Kendall Square near popular Boston area attractions.
Hotel Accommodation
NSF-DBA has negotiated a preferred rate with the Boston Marriott Cambridge Hotel. A limited number of rooms are available at this rate. Hotel reservations and payment are the responsibility of each delegate.
We will be happy to help but final confirmation and bill settlement is the delegate’s responsibility.
Venue Address and Contact Details
Boston Marriott Cambridge,
2 Cambridge Center,
50 Broadway,
Boston,
Massachusetts 02142 USA,
Tel: +1-617-227-0815
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 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
“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
An NSF International Company 
