In 2012, Mourne Training Services is offering two courses at locations throughout Europe on the topic of analytical methods for pharmaceuticals: a two day course on validating methods and a one day course on transferring methods. The courses are ideal for anyone who is involved in the validation or transfer of analytical methods; for example: analytical chemists, laboratory managers/supervisors, quality control analysts/managers, quality assurance managers, and regulatory affairs managers. Included in the course fees: Comprehensive course handouts containing useful reference material; Certificate of Attendance; access to training resources via e-MTS; optional post training assessment (leading to Certificate of Training); Expert Advice from the MTS trainer on your method validation and transfer challenges, both on the day of the training and after the event; and lunch and refreshments. Delegates on the course, Validation of Analytical Methods for Pharmaceutical Analysis, will receive a copy of the MTS training book of the same name.
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 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).
Course Schedule:
London, UK - 12th & 13th September 2012
Basel, Switzerland - 25th & 26th September 2012
Dublin, Ireland - 23rd & 24th October 2012
Manchester, UK - 13th & 14th November 2012
Berlin, Germany - 27th & 28th November 2012
Course Fees
UK: Early bird offer : £850 + VAT per person. Additional delegates from the same company: £750 + VAT per person. Full price: £950 + VAT per person.Course Fees
Other Europe: Early bird offer: €1050 + VAT per person. Additional delegates from the same company: €925 + VAT per person. Full price: €1175 + VAT per person.
Early Bird Savings Available up to 4 Weeks Before the Course Date
Transfer of Analytical Methods
for Pharmaceutical Analysis
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 a proposal for inclusion in an update 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.
Please note: Familiarity with the characteristics studied during analytical method validation is necessary for this course since these are used for method transfer. The MTS course, Validation of Analytical Methods for Pharmaceutical Analysis, is recommended.
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Course Schedule:
London, UK - 14th September 2012
Basel, Switzerland - 27th September 2012
Dublin, Ireland - 25th October 2012
Manchester, UK - 15th November 2012
Basel, Switzerland - 27th September 2012
Dublin, Ireland - 25th October 2012
Manchester, UK - 15th November 2012
Berlin, Germany - 29th November 2012
Course Fees
UK: Early bird offer: £495 + VAT per person. Additional delegates from the same company: £435 + VAT per person. Full price: £545 + VAT per person.
Other Europe: Early bird offer: €610 + VAT per person. Additional delegates from the same company: €540 + VAT per person. Full price: €675 + VAT per person.
Early Bird Savings Available up to 4 Weeks Before the Course Date
Attending Both Courses?
Course Fees UK: Early bird offer: £1225 + VAT per person. Additional delegates from the same company: £1125 + VAT per person. Full price: £1375 + VAT per person.
Course Fees UK: Early bird offer: £1225 + VAT per person. Additional delegates from the same company: £1125 + VAT per person. Full price: £1375 + VAT per person.
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