Instructor Led Online Analysis and Testing

Key Learning Objectives

On completion of this pharmaceutical analysis and testing course, delegates will know and understand:

• The essential components of a laboratory management system that can ensure data integrity
• The philosophy and principles of pharmaceutical analysis
• The basis for commonly used analytical techniques
• How to provide acting and trainee QPs with sufficient understanding of pharmaceutical analysis that enables them to have effective dialogue with the laboratories providing them with data

Course Outline

Laboratory Management Systems

• Good Control Laboratory Practice 
• Handling out-of-specification (OOS)/out-of-trend (OOT) results

Philosophy and Principles of Analysis

• Specifications and analytical methods
• Error in analytical methods
• Sampling methods/regimes
• Analytical validation and method transfer
• Analytical Refence Standards
• Equipment maintenance and calibration
• Stability testing: protocols and methods

Analytical Techniques

• Key differences between analysis of small vs large molecules 
• “Classical”’ methods of analysis
• Physico-chemical testing of solid dosage forms
• Hardness, friability, dissolution
• Spectrophotometric methods
• Infrared, ultraviolet and atomic spectroscopy
• Chromatographic methods
• High performance liquid chromatography (HPLC), gas chromatography (GC), size exclusion chromatography (SEC), thin layer chromatography (TLC), capillary electrophoresis (CE)
• Proof of structure methods
• Mass spectrometry (MS), nuclear magnetic resonance (NMR)
• Biological assays
• ELISA, PCE and SDS Page
• Pharmacognosy

Who Should Attend?

The Aspiring Qualified Person

• Our training is generally considered as the best available and our QPs are held in high regard within the industry.
• As well as being accepted in the UK, our training courses are well known and accepted by several EU countries including Ireland, the Netherlands, Austria, Hungary and Malta.
• You are more likely to become a QP with us than with any other training provider.

The Pharmaceutical Technical Professional

• Not all the people attending these courses intend to become QPs. Many use the training to develop as technical managers in other areas of pharmaceutical manufacture and control.
• Many industry professionals from a range of disciplines attend the courses as part of their continuing professional development. Taken with some of our other QP modules, this course is designed to lead to postgraduate certificate, diploma and MSc qualifications.

Prerequisites

For any queries regarding entry requirements for both QP training and/or postgraduate qualifications please contact us.

Additional information

NSF delivers instructor-led QP courses with blended training methods, in a mix of virtual and in-person courses. Please visit nsf.org/training for current dates. If you cannot see your delivery method of choice, please contact us.