Pharmaceutical Training Experts
- Benefits of Qualified Person Training
- Why Partner With NSF?
- In-House Training Process
NSF International offers an extensive range of professional pharmaceutical training courses as continuing professional development for the pharmaceutical industry. Courses cover many subjects and are designed to help you prepare for the next challenge, improve your competitiveness and build your knowledge base.
The course helps you understand, and communicate to your colleagues, causes, risks and cGMP requirements. Courses are aimed at improving operational excellence and competitive edge. Courses offered annually include:
- Human Error: Causes and Prevention
- EU GMP and Inspection Readiness
- The Role of the Qualified Person (QP)
- Risk-Base Decision Making for Sterile Products
- Pharmaceutical GMP
- Applying ICH Q10 – Pharmaceutical Quality System
- Preparing for the Future: Successful Implementation of ICH Q8, Q9 and Q10
- Pharmaceutical Auditor Training
- EU GMP Requirements for Clinical Supplies Manufacture
- Satisfying EU GMP Requirements for Sterile Products Manufacture
- Engineering Aspects of GMP
- Pharmaceutical Packaging GMP
- Change Control
- Deviation and CAPA Management
- Steam Sterilization
- Environmental Monitoring for Sterile Products Manufacture
- Process Simulation
- Contamination Control for Non-Sterile Products
For details of course dates in the US and Europe, please visit our training and education section or www.nsf-dba.com.
Benefits of Qualified Person Training
NSF has been running Qualified Person (QP) training courses for more than 20 years. QPs trained by NSF are highly regarded in the industry, and global recognition of this qualification is increasing.
NSF's course provides practical, focused, face-to-face instruction to prepare you fully for the challenges ahead. NSF offers:
- Quality instruction from seasoned professionals and University lecturers who are acknowledged experts in their field
- Tutors eligible to act as QPs; many are current or former QP assessors and several are ex-UK medicines inspectors
- A personal tutor to provide advice and support throughout the training period
- Flexibility to join or leave the series of modules at any time
- Free management skills seminars to complement your technical knowledge
The Aspiring Quality Leader and the Technical Professional
NSF runs a series of 12 modules held over 21 months in a course carefully designed to meet the requirements for theoretical training as detailed in EC Directives 2001/82/EC and 2001/83/EC and in the latest UK Qualified Person Study Guide.
Not everyone attending wants 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 or to gain a postgraduate qualification in pharmaceutical quality and good manufacturing practice.
Specific QP course offerings include:
- Pharmaceutical Law & Administration
- Medicinal Chemistry & Therapeutics
- Formulation & Processing
- Pharmaceutical Microbiology
- Active Pharmaceutical Ingredients
- Mathematics & Statistics
- Analysis & Testing
- Pharmaceutical Packaging
- Quality Management Systems
- Practical Module
- Investigational Medicinal Products
- Role & Professional Duties of the QP
For detailed information about QP courses, please visit the NSF-DBA website.
Why Partner With NSF?
NSF International is a major global provider to the pharmaceutical industry, offering training, consultancy and auditing services. The experienced education team has an outstanding international reputation beyond professional training which also includes quality management and regulatory compliance.
NSF’s range of training and educational services is the first choice of major multinationals and small start-up ventures. NSF’s aim remains the same: to train your people to the highest standards and offer the best possible advice to contribute to your company’s success.
In-House Training Process
NSF provides the training courses your employees need when and where you want it.
Our in-house training courses are built on our residential training program and tailored specifically to meet your needs. In-house courses run from half a day to five days and optimum attendance is 12 to 25 students, although more or fewer can be accommodated.
NSF believes training is most effective when it is directly relevant to the activities performed by attendees. We work closely with you to design courses that your staff can immediately relate to and that answer their specific questions.
We can offer one-time classes as well as develop a comprehensive series of courses to take the entire workforce through general GMP training and then provide specific, modular, task-orientated training for individual departments.
The course development process involves these steps:
- NSF discusses the course program with you – your objectives, the target audience, locations and timing.
- NSF provides a draft proposal and program for your review.
- NSF takes your feedback and adjusts the program to ensure it meets your needs and educational objectives.
- NSF delivers the training and program course materials, and provides attendance certificates if requested.
- NSF discusses feedback from the course attendees and stakeholders and plans any follow-up actions.
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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.