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Qualified Person Training - Pharma Biotech
- Value for Non-QPs
- Key Features
- Postgraduate Qualifications
- The QP Modules
We have been training and developing Qualified Persons since 1990. No other training provider can match our experience or our success rate.
Our training program has enabled quality professionals from the United Kingdom, Ireland, the Netherlands, Hungary, Austria, the Czech Republic, Malta, Denmark, Belgium, Jordan and numerous other countries to become practicing QPs, and QPs trained by us are widely recognized in the industry as the very best.
Embarking on training to become a QP is a major undertaking in terms of time, commitment and cost. You will only do it once, so make sure you do it right – come to us!
To talk to someone about whether this is the right course for you, if you meet the eligibility requirements, how many or how few modules you should attend, how to enroll or any other issue, please contact us at firstname.lastname@example.org.
Value for Non-QPs
Not everyone attends our QP modules because they want to become a QP. Many use the training to develop as technical managers in other areas of pharmaceutical manufacture and control.
Others attend as part of their continuing professional development. In fact, we train more individuals globally through courses at their own sites than we do through our public QP program.
The syllabus is seen by many as essential skills training for all technical leaders, managers and supervisors working in the industry supporting product realization and release.
NSF International offers Qualified Person training in conjunction with the University of Strathclyde in Scotland, one of the premier universities for pharmaceutical education in the UK. This blend of academic excellence and sound, industry-based experience sets our QP training apart from the other providers and ensures an unparalleled success rate.
The course consists of 12 modules held over 21 months and meets the requirements for theoretical training as detailed in EC Directives 2001/20/EC, 2001/82/EC and 2001/83/EC and in the latest Qualified Person Study Guide.
The modules provide practical, face-to-face tuition in master’s degree-level detail to prepare candidates for the challenging and ever-growing role of acting as a QP in today’s pharmaceutical industry. This course uniquely focuses on the knowledge and practical decision-making exercises necessary to build skills and confidence for the QP role. Sufficient time and depth are provided to grow QPs to be the best they can be and to prepare the candidates for the role ahead, not just the assessment process.
We work with you to maximize the chance for success at viva or international assessment and beyond. We provide unparalleled support, from training plan development and gap analysis to a supportive personal tutor, QP skills training, support with your application, a revision interview before your assessment and, after success, a strong, active alumni association.
We recognize that busy professionals in today’s pharmaceutical industry cannot always commit to a rigid 12-module schedule over a 21 month period, so we provide the flexibility to fit your training into your work life; you can start and finish whenever you choose and take as many or as few modules as you wish over a period that suits you.
The University of Strathclyde and NSF International are working together to bring you first-class training and valuable professional qualifications.
We offer those taking Qualified Person training the opportunity to gain a Master of Science (MSc) qualification, a postgraduate diploma (PGDip) or a postgraduate certification (PGCert) in pharmaceutical quality and Good Manufacturing Practice.
The certificate is ideal for quality professionals looking to gain further qualification or recognition in their profession. You must complete the three QP foundation modules plus three modules of your choice, and perform satisfactorily in the assessments for each to be eligible to apply for the postgraduate certificate with the University of Strathclyde.
To register for the postgraduate diploma, delegates must generally attend all modules (although exemptions on the basis of prior learning can be granted). Delegates who perform satisfactorily in all assessments may then sit the diploma examinations. If successful, they will be awarded the university diploma in pharmaceutical quality and Good Manufacturing Practice.
Holders of the postgraduate diploma who have attained a sufficient standard overall may proceed to the MSc in pharmaceutical quality and Good Manufacturing Practice by undertaking a supervised, industrially relevant project on a topic approved by the course director. Candidates are required to satisfy the board of examiners in a presentation of their project dissertation and in an oral examination. Project proposals shall normally be submitted within six months of completing the diploma course.
The QP Modules
The Qualified Person (QP) training program consists of 12 modules.
Pharmaceutical Law & Administration
QPs and other pharmaceutical technical managers must understand pharmaceutical law and administration to ensure compliance with relevant laws in Europe and beyond.
This module ensures that, in an increasingly changing world, you have a deep and detailed understanding of:
- Why we have medicines laws and what they seek to achieve
- The laws and legislative processes in the EU that impact medicinal products and the role of the QP
- The UK Medicines Act and legislative framework
- U.S. and other international pharmaceutical legislation
- Other relevant laws and guidelines
Medicinal Chemistry & Therapeutics
This module provides essential information for properly making key technical decisions regarding the fitness for use of manufactured batches. These decisions may involve:
- Patient risk
- Product quality
Formulation & Processing
Once a new chemical entity has proved its potential in clinical studies, it must be formulated into an effective medicine that is manufactured reliably so that safety, quality and efficacy are assured.
This module provides key formulation and processing information:
- How the physicochemical attributes of the drug and the therapeutic indication influence route of administration and dosage form
- How to assure bioavailability
- Methods of manufacture of the major dosage forms
Microbiological contamination of products and processes continues to be a major industry and regulatory concern. The potential impact of such contamination can be catastrophic.
This course, designed for non-biologists and non-microbiologists, provides you the knowledge, confidence and decision making risk assessment skills to prevent catastrophes.
Active Pharmaceutical Ingredients
The quality of a medicine depends on the quality of its ingredients, particularly active ingredients. QPs and other key professionals in dosage form manufacture must have a thorough understanding of how the manufacture and control of the active and its supply chain may influence the fitness for use of the finished product. In fact, Directive 2004/27/EC puts responsibility for assuring the quality of the active on the dosage form manufacturer, with specific expectations for the QP.
This course provides you with the knowledge and understanding to fulfill your responsibilities with competence and confidence.
Mathematics & Statistics
As reflected in the EU requirement for product quality reviews and in ICH Q8, Q9 and Q10, the pharmaceutical industry and regulatory authorities are becoming increasingly aware of the benefits of statistical techniques and trend analysis.
This module is designed for delegates with little or no experience in the application of statistical techniques and helps them to:
- Understand the reliability and accuracy of data and information arising from samples taken from a population
- Monitor and detect adverse trends before a process goes out of control
- Assess the capability and reliability of a process
- Understand the interaction of process parameters via experimental design
Analysis & Testing
A fundamental part of the QP’s release decision involves the review and interpretation of analytical data. This module provides a foundation of analytical techniques and their respective strengths and weaknesses to enable the QP to judge analytical data, to ask relevant questions to aid interpretation and to know when to call for additional data/advice.
Despite advances in technology, quality problems with packaging continue to occur. Print origination and packaging processes continue to be a major reason for product recalls.
This module covers all important aspects of the packaging process, from selection of suitable components, pack design, packaging processes and their associated GMP challenges, through the supply chain to the patient.
The course includes visits to a wholesaler and a pharmacy, with input from printed packaging component suppliers.
Quality Management Systems
We all know that the quality of your products depends on the quality of your people and the effectiveness of your quality management system (QMS). In fact, QPs and quality professionals can’t release product and stay in business unless the QMS is in control, but this is easier said than done. Supply chains are more complex than ever and you are being asked to do more with less, and faster! It is not surprising that failures in the QMS are a key reason for severe regulatory action in Europe and the USA.
This course provides you with answers to some really tough questions.
One of the greatest challenges facing the prospective QP is gaining a practical understanding of the equipment and procedures used to manufacture and test the broad range of dosage forms produced by the pharmaceutical industry. In fact, the majority of candidates who fail at interview do so because they do not display a practical knowledge of pharmaceutical manufacturing and testing procedures and their key vulnerabilities.
This module provides basic practical experience in these areas for the major dosage forms. It cannot take the place of practical experience in your company’s manufacturing areas and labs, but provides hands-on experience for a broad range of products and expert tuition from pharmaceutical specialists. Learning takes place at the modern facilities of the University of Strathclyde Institute of Pharmacy and Biomedical Sciences, which are used for research and teaching.
This module is open to students from other QP training courses whose syllabus does not provide practical tuition, but places are strictly limited, so book early.
Investigational Medicinal Products
The adoption of Council Directive 2001/20/EC means that:
- All clinical trial materials must be made in accordance with the principles of GMP.
- Manufacturing facilities must hold an appropriate authorization and are subject to inspection by the regulatory authorities.
- All investigational medicinal products must be subject to certification by a Qualified Person prior to release into a trial.
This course provides existing, trainee and transitional QPs with the foundation knowledge and understanding required to assess and certify investigational medicinal products and to appreciate the fundamental differences between IMPs and licensed products. It is also of value for other technical staff working with clinical trial supplies.
Role & Professional Duties of the QP
The principal objective of this course is to emphasize how QPs should conduct themselves in discharging their legal duties. Of paramount importance is the ability to focus on the broad issues of managing quality and to bring these issues together in a cohesive way when making decisions to certify medicinal products.
Throughout the course, delegates will have the opportunity to test their skills via interactive “release or reject” scenarios.
This course covers the latest QP expectations and includes a simulation of a typical UK QP interview as conducted by the three professional bodies.
Q. Do I need to attend all the modules?
A. No. Unless you wish to aim for the postgraduate diploma or MSc, you can select modules as required.
Q. How can I decide which modules to attend?
A. Delegates are offered a free gap analysis with a course tutor. Guidance can be given during a face-to-face interview or remotely by providing a detailed CV for review.
Q. How long does the course take?
A. This depends on how many modules the delegates wish to attend and where these fall in the series. A full series typically takes 18 months but some delegates prefer to spread the course over two series. Flexibility is the name of the game!
Q. How do I enroll for the postgraduate certificate?
A. The University of Strathclyde coordinates its qualification directly with the delegate, but let your tutor know and he or she will inform the University. The requirements for the certificate are attending three foundation modules and three of choice, performing satisfactorily in the module assessments and sitting the certificate exam at the University.
Q. How do I enroll for the postgraduate diploma/MSc?
A. The University of Strathclyde coordinates its qualification directly with the delegate. Typically the requirements for the diploma are attending all modules, passing both papers of the module exams and sitting the diploma exam at the University. The MSc requires this plus a workplace thesis/project, approved by the Course Director at the University.
Q. I’ve heard about the tutor system -- What is it?
A. Delegates who attend four or more modules are classed as core delegates. This brings additional benefits including a) being assigned a personal tutor who offers support and guidance through regular meetings on modules regarding the application process and experience requirements for the viva and b) a free revision interview six to eight weeks before the viva to assess readiness for the viva.
Q. Do all modules cost the same?
A. No. Cost is determined by module length (four or five days) and venue (such as the practical module in Glasgow).
Q. Once the series is finished, do I still have use of NSF Pharma Biotech’s advice and consultancy?
A. Yes. Past delegates are always welcome to contact us with comments or queries for opinion or advice. This is a free service and we are always pleased to keep in touch with past delegates.
Q. What is the success rate of NSF delegates at viva?
A. Information to date shows a pass rate of 96 percent for NSF-trained delegates.
Q. Can non-core delegates (those taking fewer than four modules) on a QP course take the exam?
A. Yes, an exam can be sent to a designated person at the delegate’s place of work. The exam should be taken under exam conditions with the designated person invigilating. Please note that these exam results would not count toward any of the postgraduate qualifications if sat at the workplace.
Q. Can the sponsor accompany the delegate to the revision interview at NSF?
A. Yes. NSF Pharma Biotech would recommend that the sponsor accompanies the delegate so that any weaknesses can be identified and the sponsor can help the delegate work on improvements before going forward for viva.
Upcoming Courses & WebinarsIn Qualified Person Training - Pharma Biotech
- Wednesday, January 27, 2016
- 11:00am - 12:00pm Eastern Time
- Monday, March 14, 2016
- 8:30am - 3:00pm GMT
- York, United Kingdom
- Tuesday, March 15, 2016
- 8:30am - 5:00pm GMT
- York, United Kingdom
- Monday, May 9, 2016
- 8:30am - 3:00pm GMT
- Glasgow, United Kingdom