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.
Training
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.
Auditing
MTS 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.
Consulting
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.
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