About this course
We all know that the quality of your products depends on the quality of your people and the effectiveness of your quality system. In fact, as quality professionals, you can’t release product and stay in business unless your QMS is ‘in control’.
A well designed and effective QMS will add business value by ensuring your company maintains a good compliance status and ensures your products remain safe for the patient.
This is easier said than done. Supply chains are more complex than ever before and you are being asked to do more with less, and faster! It is not surprising that failures in quality systems are a key reason for severe regulatory action in Europe and the USA.
The implementation of an ICH Q10 Pharmaceutical Quality System is also now becoming an expectation of regulators around the world. If your firm is not yet implementing ICH Q10 you should attend this course!
This course will provide you with answers to some really tough questions.
How This Training will Benefit You
QMS represents a key element for the Quality Leader and the Technical Professional. This course provides the tools and techniques required to make informed, science- and risk-based decisions to benefit both the business and the patient.
It will provide the background and knowledge needed by every Quality Professional and Technical Leader whether in Production, Quality, R&D, Validation, Engineering, or any other technical discipline. As with all of NSF-DBA’s courses, it is led by industry and academic experts; frequently incorporating case studies and small group sessions to facilitate learning.
NSF-DBA’s format of extended days and pre-work ensures that both you and your company benefit from the learning experience in an efficient way and with minimal time away from the workplace.
You will receive a certificate of attendance upon completing the course. Higher Degree options – a Diploma and a Masters in Pharmaceutical Quality and Good Manufacturing Practice from the University of Strathclyde can be obtained by attending a full series of courses.
Continuing Education Credit
ACPE Continuing Education Units = 2.1 CEUs
Reference Activity Number = 0616-9999-11-001-L04-P
Course outline
- How to design a quality system that is fast, flexible, simple and compliant
- How to remove wasteful ‘activities’ and dramatically improve the efficiency of your quality system to ensure it adds real value at minimal cost
- How to ensure that your system remains fully compliant no matter how tough the business environment
- How to accurately measure and continuously improve your quality system
Quality Management Systems
- The philosophy and practice of QA, GMP and QC
- ICH Q10 – Pharmaceutical Quality System
- ICH Q9 – Quality Risk Management
- ISO 9000: A model for a quality system
- The essential elements of an effective QMS
- Quality performance indicators – how and what to measure
Good Manufacturing Process
- The crucial elements of GMP
- EU and US GMPs – compared and contrasted
- The what, why and how of the following will be examined in detail:
- Documentation systems
- Qualification and validation
- Deviation reporting and problem solving
- Change management and control
- Complaints and recalls
- Effective training programs
- Contracting work out – the management and control of contractors
- Auditing and self-inspection
- Quality costing
- Production planning and inventory control systems
Survival Skills
- How to influence and persuade others
- Conflict – how to avoid and manage when necessary
- Decision making skills and techniques
- Risk assessment tools
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 question 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
We believe that our team of experts are the best available. Not only have they got years of experience in the industry, but they are committed to tutoring and helping those inside the industry to improve and raise the standards. We understand that you attend courses to learn about the latest regulations and to get your questions answered.
Our experts for this course are:
What you've said
What previous delegates said about this module in Europe
“A great course, with really informative teamworks. Particularly liked the ‘bridge’ diagram of the PQS.”
Matthew Scarff, Rosemont Pharmaceuticals, UK
“Learned a lot. Lots of interaction – great teachers, very experienced/enthusiastic. I will try and come back for more modules! Thank you a lot.”
Margreet van der Meij, Erasmus Medical Center, The Netherlands
“The course more than met my requirements of learning about QMS and what is coming in the future. It was well structured and has given me a lot of food for thought and motivation to improve my business and myself.”
Adam Haigh, Perrigo, UK
“Course well delivered by passionate presenters. Good to get best industry practices from experienced people. Good to get MHRA insight.”
Peter Griffiths, Patheon, UK
“Excellent – knowledgeable lecturers, as always. Inspired strategic thinking and broadened my perspective.”
Barbara Glantschnig, Octapharma Pharmazeutika, Austria
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