Training and Education at NSF
- Core Beliefs
- Why Work With NSF?
- Developing Your Career
NSF Health Sciences Pharma Biotech provides a comprehensive range of courses on numerous subjects relating to pharmaceutical manufacturing, auditing and quality management that are widely recognized as providing world-class continuing education.
Core programs, in addition to our modular Qualified Person program, include:
Effective Pharmaceutical Audits and Self Inspections
At NSF, we designed and developed the first internationally recognized and certified course for pharmaceuticals based on Good Manufacturing Practice (GMP) and auditing the quality management system. This course is certified by IRCA (the International Register of Certificated Auditors) and provides extensive practical support and training for the pharmaceutical auditor, including a practiced toolkit of skills. This course has grown over the past few years with hundreds now trained and many companies requiring the training and certification of those joining their audit teams.
Human Error Reduction
This comprehensive approach teaches the science of human error and a methodology for conducting investigations attributed to human error in order to identify CAPAs which focus on the underlying contributing factors. The program is designed to achieve dramatic reductions in human error, especially deviation re-occurrence. The program complements existing site initiatives such as Lean, Six Sigma and root cause analysis and helps investigators see human error from an entirely different point of view.
Other topics we frequently cover include:
- Deviation reporting and CAPA
- Pharmaceutical Good Manufacturing Practice (GMP)
- Pharmaceutical legislation updates
- Good Distribution Practice (GDP)
- GMPs for clinical trials manufacturing
- Sterile products manufacture
- Preparing for regulatory inspections
For detailed course information, see our complete range of courses.
For more information about NSF Pharma Biotech training and education in the U.S., email firstname.lastname@example.org or call +1 857.277.0060.
For more information about NSF Pharma Biotech training and Education in Europe, email email@example.com or call +44 1751 432 999.
We believe in providing education, not just training. Education is what remains when training has been forgotten.
The best education is in the workplace, but, if that’s not possible, we bring the workplace into the classroom. Our courses focus on knowing how and knowing why.
We help attendees improve their foundation skills in:
- Decision making
- Problem solving
- Change management
Why Work With NSF?
We believe in planning for the future and we offer:
- Excellent connections with industry and regulatory bodies (EU, FDA, WHO)
- Expert knowledge of pharmaceutical regulations to help you interpret, set and implement standards based on good science and pragmatism
- Thorough understanding of best industry practices and future trends, with thousands of clients worldwide
- Crisis management and crisis prevention expertise
We also believe in challenging the status quo and thinking differently. We:
- Listen (diagnose before we prescribe)
- Question (using the 5 whys)
- Challenge from all angles and innovate
- Share best practice
- Mentor and guide to deliver best-fit solutions
- Customize solutions as we know one size doesn’t fit all
Developing Your Career
One of the most frequent questions instructors are asked after one of our training courses is "That was great, but what should I do next?"
To help you get the most value from our classes, we created tools to help you see how a training or development course can fit in with your continuing professional development (CPD) requirements or career path. Our career path icons help you select courses that logically fit together or that former attendees have linked and found useful. We also have posters of career path options at most of our major events, along with trainers to answer questions.
Some typical career path examples include:
- A participant in the Good Manufacturing Practice (GMP) course who meets the prior knowledge requirements for the auditor course may want to move into auditing.
- Participants in the GMP course who are hungry for more knowledge may find the pharmaceutical quality and GMP Master of Science (MSc) programs of interest.
- An auditor who requires CPD in some technical areas (such as quality management systems, analytical testing or dosage form specific training) may choose technical modules from the pharmaceutical quality and GMP MSc programs.
- An analyst is likely to want more detail in method validation, the latest updates on OOS, etc.
- A senior manager may want to attend elements of the QP course to understand the role and duties of the QP or pharmaceutical law.
Our trainers are happy to talk to individuals about their personal requirements and make suggestions about the best ways forward. For the QPs, this ongoing support comes through our free gap analysis and tutor support meetings.
For more information about career paths with NSF Pharma Biotech, contact firstname.lastname@example.org.
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What level of experience and knowledge would you recommend students have prior to attending the Effective Pharmaceutical Audit and Self Inspections course?
Delegates who attend this course are expected to have relevant GMP and/or audit experience. Delegates are expected to have a working knowledge of EudraLex Volume 4, Chapters 1 – 9 or US 21 CFR Parts 210/211, and an awareness of ICH Q8, Q9 and Q10.
Is there a written exam in the Effective Pharmaceutical Audit and Self Inspections course?
Yes. On the last day, there is a two-hour written examination. During the week of the course, time is spent working through an example paper and delegates are given the opportunity to have one and a half hours of exam preparation time before the exam. Delegates for whom English is a second language are allowed an extra 30 minutes for the exam.
I am a Qualified Person (QP) and I want to become an IRCA-registered auditor. How do I proceed?
If you are interested in becoming an IRCA-certificated auditor, the first step is to attend our Effective Pharmaceutical Audits and Self-Inspections PQMS Auditor/Lead Auditor Course, A17638. Once you have passed the NSF course and exam, you will need to apply to IRCA for certification and fulfil their criteria. For more information, see www.irca.org.