Pharmaceutical Analysis and Testing (QLP Module 7)Print
A fundamental part of the product release decision is the review and interpretation of analytical data.
$2950.00 per delegate
$2360.00 for additional delegates from same site or early bird booking
About this course
A fundamental part of the release decision is the review and interpretation of analytical data. It is therefore essential that those responsible understand the basis of the analytical techniques and their respective strengths and weaknesses.
This course seeks to provide a foundation of knowledge to enable individuals to judge analytical data, to be able to ask relevant questions to aid interpretation and to know when to call for additional data/advice.
This course is designed for delegates seeking to stay current on Good Control Laboratory Practice (GCLP) or wishing to deepen their knowledge of pharmaceutical laboratory operations. The scope will encompass analytical method validation and method transfer – both relevant to typical small molecules analytical testing and methods commonly used to test biologics. In addition, regulatory agency focus regarding method validation issues, out-of-specification handling, and data integrity will be covered.
Continuing Education Credits
ACPE Continuing Education Units = 3.0 CEUs
Reference Activity Number 0616-9999-12-003-L04-P
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.
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
- Proof of structure methods
- Microbiological assays
- Biological assay methods
- 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.
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.
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,
2 Cambridge Center,
Massachusetts 02142 USA,
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
“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