About this course
A fundamental part of the product release decision is the review and interpretation of analytical data. It is therefore essential that the Technical and Quality Leader understands the basis of the analytical techniques and their respective strengths and weaknesses.
This course seeks to provide a foundation of knowledge to enable the Quality Leader to judge analytical data, to be able to ask relevant questions to aid interpretation and to know when to call for additional data/advice.
The module is designed for delegates with a scientific background who wish to obtain a broader knowledge of Good Control Laboratory Practice (GCLP). The module may also be suitable for Analytical Chemists and Biochemists who are new to the Pharmaceutical Industry.
For delegates who already have a deeper knowledge of analysis and testing there will be opportunities to discuss issues with the course tutors
How This Training will Benefit You
Analysis and Testing 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.
This course on Analysis and Testing is based upon a key component of the Qualified Persons instruction which NSF-DBA offers in Europe. It sets a new standard for practical, results oriented instruction.
A Certificate is granted by NSF-DBA for attendance. 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 Credits
ACPE Continuing Education Units = 3.0 CEUs
Reference Activity Number 0616-9999-12-003-L04-P
Course outline
Philosophy and Principles of Analysis
- Sampling methods/regimes
- Choice of analytical techniques
- Analytical validation and method transfer
- Equipment maintenance and calibration
- Stability testing – protocols and methods
- Pharmacopoeia and monographs
Physicochemical Properties/Methods of Analysis
- Analytical method selection
- Physical properties of materials
- ‘Classical’ methods of analysis
- Spectrophotometry
- Chromatography
- Proof of structure methods
- Microbiological assays
- Biological assay methods
Laboratory Management
- Principles of GCLP/management
- Handling atypical results (eg OOS/OOT results)
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, provide delegates with an opportunity to obtain answers to their specific questions and concerns.
Venue
Royal Sonesta Hotel Boston, MA, USA
The Royal Sonesta hotel is minutes from downtown Boston. Located
along the Charles River, it is close to many of the Boston historic sites,
including the Boston Science Museum. There is excellent shopping
nearby.
Hotel Accommodation
NSF-DBA has negotiated a preferred rate with the Royal Sonesta
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.
There are a number of other hotels located within minutes from the
Royal Sonesta Hotel including the Marriott Hotel, the Courtyard Inn
and Le Meridien Hotel, all situated in Cambridge. Downtown Boston
hotels are within 15 minutes by taxi or public transportation of the
meeting venue.
Venue Address and Contact Details
Royal Sonesta Hotel,
40 Edwin Land Blvd.,
Cambridge,
MA 02142,
Tel: +1-617-806-4200
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:
Guest Speaker: David Watson, University of Strathclyde, Glasgow, UK
What you've said
What Previous Attendees Said About This Course in Europe
“Very good course information and enjoyable group sessions”
Matthew Scarf, Rosemont
“Overall another excellent and very enjoyable course. I learnt a lot in a short time”
John Horry, Reckitt Benckiser
“A course […] both enjoyable and more importantly informative and very well explained”
Nigel Chesterton, Bio Products, UK
“Very intensive but still very enjoyable. The whole QP course has been excellent and well worth the money”
Carol Sandercock, Newcastle University
