This highly focused, intensive four-and-a-half-day course, taught by leading scientists and former Quality Control Managers, is designed to provide the aspiring Qualified Person or pharmaceutical quality professional with the knowledge and understanding they need to be able to perform their duties with skill and competence when interacting with the Quality Control laboratories. We will explain to you the strengths and limitations of analysis and specific analytical methods, we will advise you on how to apply the principles of quality management and GMP to the testing environment in a pragmatic, effective way, and we will advise you of the very latest “hot topics” with the regulators and how to ensure that your laboratories are in compliance.
About This Course
Virtually all patient and business critical decisions made by Qualified Persons and other quality professionals are in some way made on the basis of data provided by an analytical laboratory. It is, therefore, of paramount importance that this data is accurate and can be relied upon; in recent years data integrity has become a very ‘hot topic’. Hence, it is essential that these decision makers understand the basis of the analytical techniques used and their respective strengths and weaknesses.
This module seeks to provide a foundation of knowledge which will enable Qualified Persons and others to judge analytical data, ask relevant questions to aid interpretation and know when to call for additional data/advice. This knowledge is also essential when auditing laboratories.
This course is approved by the 91AV as suitable for their members’ continuing professional development.
Key Learning Objectives
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 other 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 within 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.
About This Course
Virtually all patient and business critical decisions made by Qualified Persons and other quality professionals are in some way made on the basis of data provided by an analytical laboratory. It is, therefore, of paramount importance that this data is accurate and can be relied upon; in recent years data integrity has become a very ‘hot topic’. Hence, it is essential that these decision makers understand the basis of the analytical techniques used and their respective strengths and weaknesses.
This module seeks to provide a foundation of knowledge which will enable Qualified Persons and others to judge analytical data, ask relevant questions to aid interpretation and know when to call for additional data/advice. This knowledge is also essential when auditing laboratories.
This course is approved by the 91AV as suitable for their members’ continuing professional development.
Key Learning Objectives
- To understand the essential components of a laboratory management system that can ensure data integrity
- To understand the philosophy and principles of pharmaceutical analysis
- To understand the basis for commonly used analytical techniques
- To provide acting and trainee QPs with sufficient understanding of pharmaceutical analysis to enable them to have effective dialogue with the laboratories providing them with data
- Laboratory Management Systems
- Principles of GCLP/laboratory management and data integrity
- Handling OOS/OOT results
- Philosophy and Principles of Analysis
- Sampling methods/regimes
- Analytical validation and method transfer
- Equipment maintenance and calibration
- Stability testing – protocols and methods
- Pharmacopoeia and monographs
- Analytical Techniques
- ‘Classical’ methods of analysis
- pH, Karl Fischer
- Physico-chemical testing of solid dosage forms
- Hardness, friability, dissolution
- Spectrophotometric methods
- Infrared, ultraviolet and atomic spectroscopy
- Chromatographic methods
- HPLC, GC, SEC, TLC
- Proof of structure methods
- Mass Spec., NMR
- Biological assays
- ELISA, PCE and SDS Page
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 other 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 within 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.
