Course: Validation and Transfer of Methods for Pharmaceutical Analysis

Summary:
This course will provide you with the requisite scientific knowledge and understanding of analytical method validation, verification and transfer to allow informed interpretation of current regulatory guidance from EMA, FDA and ICH, e.g. Q2(R1).

The data generated using analytical test methods is essential for many of the critical decisions made in the pharmaceutical industry. To be confident in the integrity of this data it is crucial that the methods are fit for purpose. To demonstrate that a method is fit for purpose will require either a validation, verification or transfer study, depending on the source of the method in question.
This course provides a detailed explanation of how these studies are performed, 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.

The full course takes place over 3 days but if preferred, it is possible to attend the first 2 days only for a method validation course or the last day only for a method transfer and verification course. In the case of attendance on the last day only it is essential that delegates are familiar with validation characteristics since these are used for method transfer and verification. Click here for Agenda & Detailed Course Description (printer friendly)

Suitable for:
Anyone who needs to understand how methods are validated, verified or transferred, 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.

Availability:

Open Enrolment Training
Click here for Costs & Online Booking Form.

London, UK - 22nd to 24th April 2015
Venue: Hilton Garden Inn, London Heathrow Airport (formerly Jurys Inn Heathrow)
For early bird savings, book on this course before 25th March.

Dublin, Ireland - 27th to 29th May 2015
Venue: Metro Hotel Dublin Airport
For early bird savings, book on this course before 29th April.

London, UK - 30th September to 2nd October 2015
Venue: Hilton Garden Inn, London Heathrow Airport (formerly Jurys Inn Heathrow)
For early bird savings, book on this course before 2nd September.

Berlin, Germany - 30th November to 2nd December 2015
Venue: GLS Campus Berlin
For early bird savings, book on this course before 2nd November.

On-site Training
The course may be delivered at your site; this option includes customisation to meet your specific requirements. Contact us for a quotation.

Visit the Course List page on our website for full details of all our available training courses in 2015.

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New 'Data Integrity Definitions' Guidance from MHRA

The MHRA has published a new set of guidance relating to data integrity: Good manufacturing practice: data integrity definitions. First published on 23rd January 2015, the guidance was revised on 13 March 2015 following stakeholder feedback.

The description provided on the MHRA website reads as follows:

"This guidance sets out our expectations for data integrity in good manufacturing practice (GMP).

It complements existing EU GMP guidance and should be read in conjunction with national medicines legislation and the GMP standards published in Eudralex volume 4."


MTS offers a range of services related to laboratory data integrity including auditing, training courses, and consultancy. Our new training course, 'Laboratory Data Integrity', is comprised of three days, you can attend any preferred combination of days: 

1: Introduction to Laboratory Data Integrity; cGMP in the Pharma Lab
Day 1 introduces the fundamental concepts of laboratory data integrity in the context of working within a quality management system and as such this course also acts as an introduction/refresher to laboratory cGMP.

2: Applying Data Integrity in the Laboratory; Minimising Analytical Error
Day 2 deals with the effects of analytical errors on laboratory data integrity. This involves building an understanding of the nature and sources of analytical errors so that their effects can be minimised during testing, leading to high standards of data integrity and reduced numbers of OOS/OOE results due to laboratory errors.

3: How to Improve Data Integrity in the Pharma Lab
Day 3 focusses on improving laboratory data integrity and associated quality management systems by review of laboratory processes to identify data integrity risk, and implementation of appropriate solutions, paying particular attention to deficiencies that are commonly cited by regulatory authorities.

Visit the MTS website for more information and details of the open enrolment dates and locations, or Contact us to find out more.

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Upcoming Courses from Mourne Training Services:

22nd to 24th April 2015 in London, UK:Validation and Transfer of Methods for Pharmaceutical Analysis
Venue: Hilton Garden Inn, London Heathrow Airport

19th to 20th May in London, UK:
How to Develop Stability Indicating HPLC Methods 
Venue: Hilton Garden Inn, London Heathrow Airport

27th to 29th May 2015 in Dublin, Ireland
Validation and Transfer of Methods for Pharmaceutical Analysis
Venue: Metro Hotel Dublin Airport

Visit the Course List page on our website for more information on these courses and for full details of all our available training courses in 2015.

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