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Validation of Analytical Methods for Pharmaceutical Analysis

 
  February 18, 2013  
     
 
Mourne Training Services, Dublin
June 5 - 6, 2013


Description:

The data generated using analytical methods is essential for many of the critical decisions made in the pharmaceutical industry. To be confident in the reliability of this data it is crucial that the methods are fit for purpose. Analytical method validation is the process of demonstrating that a method is suitable for its intended use. This two day course provides a detailed explanation of how analytical methods are validated, enabling a full understanding of method performance characteristics and associated statistics, and how they are applied to the techniques used for analysing drug related samples. This knowledge will enable informed interpretation of the current regulatory guidance on validation, namely ICH Q2(R1) and guidance from FDA and EMA on bioanalytical methods.

The approach of this course is to focus on the principles of method validation thereby enabling application to different types of samples and analytical techniques. Case studies are employed to allow consideration of real life scenarios. Examples relating to small molecule drug substances and formulated products; to physiochemical methods for biotechnological/biological products; and to bioanalysis are included. Particular attention is paid to the most common analytical techniques used for pharmaceutical analysis, e.g., High Performance Liquid Chromatography (HPLC).

Who should attend:

Anyone who needs to understand how methods are validated, either to design and carry out the investigation, or to interpret the data generated. For example:  Analytical chemists, laboratory managers/supervisors, quality control analysts/managers, quality assurance managers, and regulatory affairs managers.

Included:

Comprehensive course handouts; Certificate of Attendance; access to training resources via e-MTS; optional post training assessment (leading to Certificate of Training); post training support; and a copy of the MTS training book, Validation of Analytical Methods for Pharmaceutical Analysis. Lunch and refreshments are included for open enrolment training courses.

 
 
Organized by: Mourne Training Services
Invited Speakers:

Speaker Details:

Oona McPolin BSc, MSc CSci, CChem, MRSC

Oona has considerable experience and is fully qualified in the areas of both pharmaceutical analysis and training practice. She has worked as an analytical chemist in the pharmaceutical industry for over 17 years on a range of drug development projects and has been responsible for many pharmaceutical analysis training programmes during this time. Oona is the author of two books, ‘An Introduction to HPLC for Pharmaceutical Analysis’ and ‘Validation of Analytical Methods for Pharmaceutical Analysis’.

Oona consolidated many years of training experience by obtaining the industry standard qualification for training, the Certificate in Training Practice, awarded by the Chartered Institute of Personnel and Development (CIPD). In obtaining this qualification she was a recipient of a 2008 High Achiever’s Award from the CIPD NI branch.

Key Skills:

·         Training consultant specialising in analytical chemistry relating to pharmaceuticals; design and deliver training courses on a range of topics including validation and transfer of analytical methods and high performance liquid chromatography (HPLC).

·         An analytical chemist with over 17 years' experience in the field of pharmaceutical analysis; developing, validating and implementing analytical methods to support the drug development process in projects such as process and formulation support, stability studies, forced degradation studies, and regulatory submissions.

·         Fully qualified award winning trainer with extensive experience in design and delivery of effective training for technical subjects.

·         Expertise in a wide range of analytical techniques. Specialising in HPLC, with particular interest in strategies for method development including the use of automation, computer simulation and column classification data.

 
Deadline for Abstracts: N/A
 
Registration:

http://www.mournetrainingservices.co.uk/booking_vampa_euro.html

E-mail: info@mournetrainingservices.co.uk
 
   
 
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