Thursday 28 April 2016

Upcoming Method Development Course

2nd & 3rd June 2016, Hilton Garden Inn London Heathrow, UK
Early booking rate (until 5th May): £925 + VAT (20%)
Group discounts are available on request

This course is suitable for both investigating whether an existing HPLC method is stability indicating or for developing a new stability indicating HPLC method.

You will learn:
  • Why stability indicating methods are required;
  • How HPLC method parameters, such as column and mobile phase, affect the chromatographic separation and how to find the best conditions;
  • How to perform forced degradation stress studies to obtain potential degradation products; and
  • How to investigate mass balance for analytical methods.
Visit the MTS website for more information and for the online booking form.

Other related courses from Mourne Training Services:
Validation and Transfer of Methods for Pharmaceutical Analysis
Laboratory Data Integrity


Wednesday 20 April 2016

MTS Recommends...

Impact from the Recent Issuance of ANVISA Resolution RDC-53/2015 on Pharmaceutical Small Molecule Forced Degradation Study Requirements

By Peter Tattersall, Suwimon Asawasiripong, Ivone Takenaka, and John A. Castoro
American Pharmaceutical Review, March 31, 2016

Friday 15 April 2016

Data Integrity Services from MTS Ltd

Data Integrity Services from Mourne Training Services Ltd
In recent years data integrity has become a 'buzz' term in the pharmaceutical industry due to the regularity of problems being given the label during regulatory inspections. Mourne Training Services Ltd (MTS) has significant expertise in this area since integrity of data is the primary aim of all the services we offer.

MTS offers specific Training, Auditing and Consulting services relating to data integrity.

Courses in data integrity may be required to achieve a number of different outcomes such as:
  • Demonstrate commitment to data integrity in the laboratory;
  • Raise awareness for all staff to understand the issues surrounding laboratory data integrity and how it affects them;
  • Strengthen laboratory quality management systems to improve data integrity and remove falsification potential
MTS has worked with customers to design training that met these outcomes, which was customised to their unique requirements in terms of content and timings. We can do the same for you. We have designed 3 x 1 day courses that we offer as open-enrolment training which also provide a good starting point for selecting content in a bespoke course intended for in-house use.
The courses are:

1: Introduction to Laboratory Data Integrity; cGMP in the Pharma Lab
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
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
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.

Full course descriptions are available on the MTS website.

Data Integrity Services from Mourne Training Services LtdMTS specialises in laboratory-based audits which are carried out by myself, Oona McPolin, an IRCA certified lead auditor with extensive experience in auditing laboratories against:
  • Regulatory expectations, using standards such as the GMPs from the EU, FDA, etc.;
  • Best Practice in the analytical laboratory;
  • Specific objective requested by the customer, e.g., data integrity related issue such as audit trails.
MTS will provide an audit to suit your requirements which includes a detailed audit report and optional action plan. If a training need is indicated by the audit we can help to design and/or deliver a suitable training programme.

MTS can assist with carrying out a gap analysis for data integrity or to provide any other assistance that you may require.

Contact us today to discuss your Training, Auditing and Consulting requirements and for a no obligation quotation.


Thursday 14 April 2016

MTS Recommends... Understanding the Layers of a Laboratory Data Integrity Model

Understanding the Layers of a Laboratory Data Integrity Model

By R.D. McDowall
Spectroscopy,  Apr 01, 2016, Volume 31, Issue 4, pg 14–23

Update to MTS Company Details

Mourne Training Services is now a limited company, registered in Northern Ireland under company number NI637196.

Thursday 7 April 2016

MTS Recommends... Understanding Measurement Uncertainty in Weighing

Understanding Measurement Uncertainty in Weighing
A scientific approach to calibration and routine testing of balances ensures accurate results.

By Ian Ciesniewski, Joanne Ratcliff, PhD
Pharmaceutical Technology, Volume 40, Issue 4, pg 78–82, Apr 02, 2016