About this course
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 fulfill 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 requirements of the new Pharmaceutical Quality Management System. 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, 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
Course outline
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
Standards covered
- GMP
- ISO 9000
- PS 9000
- IPEC guides
- ISO 19011
Initiating, preparing and conducting the audit
- Materials management
- Documentation systems
- Sterile products
- Oral solid dose
- Packaging
- Laboratories and many more
Concluding the audit
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.
For further information, please contact Gill Gibbeson by telephone +44 (0) 1751 432999, or email [email protected]
To book a place, please follow the ‘book now’ link on the right of your screen or contact [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 Hotel,
Two Cambridge Center,
50 Broadway,
Cambridge,
Massachusetts 02142 USA,
Tel: 1-617-494-6600~
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.
What you've said
The NSF-DBA ‘Effective Pharmaceutical Audits and Self-Inspections’ course is viewed by past delegates as one of our most favoured and successful courses. Read what our pilot delegates had to say:
“Excellent course, materials and tutors. Surpassed my expectations. Thanks!”
Barry Cook, Sanofi-Aventis Pharma, UK
“Very good tutors with extremely high level of knowledge. Thank you for that fantastic training.”
Kathrin Haberstroh, F Hoffman-La Roche, Switzerland
“Excellent course and tutors. Useful tips and information on conducting audits and handling auditees.”
Kathryn Fraser, Dales Pharmaceuticals, UK
“Excellent course, good fun while delivering the knowledge in an effective and interactive way.”
Martin Bannon, Warner Chilcott, UK
“Excellent tutors, with a vast range of knowledge and experience. Very informative course.”
Margaret Rushe, Abbott Ireland Pharmaceuticals, Republic of Ireland
“My attendance to this course will help convince our auditors that I am suitably qualified to perform audits (both suppliers and self-inspection).”
Kenny Cowan, Norbrook Laboratories, UK
“Really good professionals at NSF-DBA. Thanks for sharing your knowledge/expertise with us.”
Ervin Cuprill, F Hoffman-La Roche, Switzerland
“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, HMR Labs, UK
So far over 100 people have been through the pilot courses with 95% success at the exam stage.
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