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HPLC Method Development and Validation

3-day course, 3rd day optional

2020 Dates TBC

Radisson Blu Edwardian Kenilworth, London

HPLC is a potent analytical tool, allowing for the separation, identification and quantification of drug substances. It also presents many challenges, from the correct use of instrumentation, to analysing results, to the fulfilment of the regulatory requirements of method validation.

Over two days, this course will offer delegates the opportunity to examine the core aspects of HPLC theory and method development, including troubleshooting. Over the course of an optional third day, delegates will examine quantitation and method validation.

Delegates may choose to attend either the first 2 or all 3 days.

The course is also available as online course, check the website for dates>>

Dr Mark Powell is a Fellow of the Royal Society of Chemistry (RSC) with over 25 years’ experience as an analytical chemist. He is an expert in sampling and sample preparation, chromatography (liquid and gas), spectroscopy (atomic and molecular) and pharmaceutical dissolution testing.  Mark was Programme Leader for the MSc in Instrumental Chemical Analysis at Liverpool John Moores University’s School of Pharmacy and Chemistry. In 2010 Mark was appointed Scientific Manager at Quay Pharmaceuticals, his work there resulting in a number of published papers and presentations at international scientific conferences.  Mark left Quay Pharmaceuticals in September 2013 to set up Mark Powell Scientific, working in training, consultancy and expert witness assignments.

  • Know the important chemical parameters affecting HPLC separation

  • Be familiar with chromatographic theory

  • Understand HPLC retention mechanisms and stationary phase types

  • Know how to improve resolution between closely-eluting peaks

  • Be able to troubleshoot HPLC system faults

  • Approach the development and validation of quantitative HPLC methods in a logical, scientifically-sound manner

This course will be beneficial to personnel working in the following areas:

  • Analytical (scientist/chemist)
  • Analytical development
  • Validation
  • Technician
  • Project Manager
  • Pharmacist
  • Formulation
  • R&D
  • Stability
  • CMC

Very interactive course and it was oriented for our specific needs for improvement! 

Really enjoyed the ability to interact and discuss with the trainer the problems and issues I am facing everyday and queries about analytical challenges.

Product Development Specialists, PharOS Ltd.

The course covers a range of levels to keep each course member on the same level of understanding. I enjoyed discussion options for improvements that can be applied. Especially enjoyed the troubleshooting and validation sections!

Laboratory Analyst, Surepharm Services Ltd.

Specifications for Small Molecule Drug Products Webinar

Led by Dr Mark Powell, a Fellow of the Royal Society of Chemistry (RSC) with over 25 years’ experience as a senior analytical chemist. In 2013, Mark set up Mark Powell Scientific, a company that offers training and consultancy services in analytical chemistry. The webinar will cover:

  • Regulatory guidance (ICH, FDA, EMA)
  • Tests appropriate to different dosage forms
  • Dissolution specifications for immediate-release, modified-release and extended-release drug products
  • Dissolution specifications in the context of the biopharmaceutical classification system
  • Control of polymorphism, enantiomeric purity, drug-related impurities and microbiological contamination
  • Specifications for combination drug products
  • The role of specifications in maximizing drug product stability

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