Data Integrity for the Pharmaceutical Industry

Available as an intensive on-site 1 day course in the requirements of data integrity in today’s laboratory. 

Who should take this course? 

This course is designed for laboratory personnel responsible for ensuring and auditing integrity of data in today’s laboratory. It will also be useful for managers and other staff involved in the process. For those workers who need to be aware of this area but are not directly responsible, this class will give an insight into the requirements of data integrity. Those with some laboratory experience will benefit from this course more than those with no experience 

What does it cover? 

This 1 day course on data integrity auditing will provide you with everything you need to familiarise yourself with the key requirements and consequences of data integrity. Case studies and practical exercises will fully equip and prepare you for this complex but vital area of laboratory regulations and requirements.This course provides essential information on the MHRA and FDA guidance on data integrity and will help you discover what you need to do to protect both yourself and your company.
What will I get from this course?
You will learn and understand the requirements of data integrity. You will be able to make recommendations and implement suitable systems and working practices in your laboratory, in order to meet these requirements. By planning ahead, you will be able to better to identify and avoid the pitfalls of this vital area. 

Course Outline 

Introduction and fraudulent data case studies 
Extracts from regulatory enforcement letters relevant to data integrity 
The requirements of data integrity 
Sampling and traceability 
Informal testing (e.g. trial injections) 
Computerised systems –date stamps, audit trails and user accounts 
Laboratory data systems – data acquisition and processing methods 
Reporting and archiving results 
Practical tips 
Auditing laboratory records 
Auditing laboratory data systems 
Auditing LIMS systems 

For further information about this course or others, simply contact us on 0118 930 3660 or Email: seminars@hichrom.co.uk or complete & return the attached booking form.
 

Radison Blu Airport, Manchester

Room 208, Radison Blu Airport, Manchester, Chicago Avenue, Manchester, M90 3RA, United Kingdom