Transfer of Analytical Methods for Pharmaceutical Analysis

Course Description:

Transferring an analytical method from one laboratory to another should be straightforward but unfortunately it is a process which is often problematic. Recognition of this has resulted in a new USP chapter <1224> and an update to chapter 6 of the EU GMP regulations. In this one day course the different approaches to transfer are explored fully and case studies are used extensively to follow the process from review of the method prior to transfer, to creating a suitable protocol with relevant acceptance criteria, and evaluating the results generated to assess whether the transfer has been successful.

Suitable for:

Anyone involved in the transfer of analytical methods. For example:  Analytical chemists, laboratory managers/supervisors, quality control analysts/managers, quality assurance managers, and regulatory affairs managers.

Please note: Familiarity with the characteristics studied during analytical method validation is necessary for this course since these are used for method transfer. The course, Validation of Analytical Methods for Pharmaceutical Analysis, is recommended.

Included:

Comprehensive course handouts; Certificate of Attendance; access to training resources via e-MTS; optional post training assessment  (leading to Certificate of Training); and post training support. Lunch and refreshments are included for open enrolment training courses.

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.

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