Analysis and Testing Training

This highly focused, intensive course is taught by leading scientists and former quality control (QC) managers. It is designed to provide the aspiring Qualified Person or pharmaceutical quality professional with the knowledge and understanding they need to perform their duties with skill and competence when interacting with QC laboratories.

During our pharmaceutical analysis training course, we explain the strengths and limitations of analysis and specific analytical methods. You learn how to apply the principles of quality management and Good Manufacturing Practice (GMP) to the testing environment in a pragmatic, effective way. We also advise you on data integrity and how to ensure that your laboratories are compliant.

Virtually all critical patient and business decisions made by QPs and other quality professionals are in some way based on data provided by an analytical laboratory. Therefore, it is of paramount importance that this data is accurate and reliable. In recent years, data integrity has become a very hot topic. Hence, it is essential that decision makers understand the basis of the analytical techniques used and their respective strengths and weaknesses.

This course seeks to provide a foundation of knowledge which enables QPs 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 Royal Society of Chemistry as suitable for its members’ continuing professional development.

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

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

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

Course tutors will be selected from the following:

David Breen – University of Strathclyde - David has worked in the area of drug development and design for over fifteen years, publishing a number of articles and reviews in the field as well as contributing to several text books and is currently the course director on the MSc Pharmaceutical Analysis programme at the University of Strathclyde.

Oona McPolin – Oona is a training consultant specializing in learning and development relating to chemical analysis, and in particular analysis of pharmaceuticals. She is an expert in a range of analytical chemistry topics including high performance liquid chromatography (HPLC).

David Waddington – David has extensive pharmaceutical and food supplement QA, QC and manufacturing experience gained over 30 years.

Tony James – Tony has over 30 years’ experience in the pharmaceutical industry and has extensive expertise in pharmaceutical testing, laboratory controls, GMP, manufacturing processes, Pharmaceutical Quality Systems and auditing. He is a Qualified Person working across a range of clinical trial and commercial products including sterile and biotech products, biologics, ATMPs, oral solid and liquid dosage forms, and topical dosage forms. Tony has knowledge and experience of a wide range of regulators and regulatory requirements.

Multi-delegate discounts available. Discounts also offered to NHS staff and charities.