Expanding our library of In-House training courses, these interactive and hands-on practical courses are designed for anyone who requires a better understanding of the application and regulatory environment.  Our courses are ideal for both medical and non - medical personnel, including those from clinical research, regulatory affairs, strategic marketing and medical information departments.  

 

 

Human error is often acknowledged as the major cause of many incidents, whether relating to safety, quality or productivity.  This 3 day course explains the underlying reasons why humans make mistakes and how you can prevent or possibly eliminate them from occurring. 

 

 

Whether they are in the business of manufacturing, design and development, or purely providing a service, the concept of Lean Six Sigma is being embraced by companies worldwide.  This course provides a good introduction to Lean Six Sigma, but equally important is its coverage of the process of change management, a key ingredient in the implementation of any new concept. 

 

 

Although organistions clearly identify deviations, rarely do they carry out a well structured investigation with an accurate root cause analysis or CAPA.  This course provides a full understanding of the various techniques available to ensure that the Corrective and Preventive Actions (CAPA) system is achieving its desired results and helps delegates understand the process of investigation through the eye of a 'crime scene investigator.'

 

 

Training cannot be viewed simply as an occasional pastime delivered on an ad hoc basis.  Skilled and knowledgeable staff are the key drivers in most businesses and each and every year organisations will take significant risks by not ensuring that employees are competent to carry out their role.  Participants will develop a wide range of necessary skills, from developing a Learning and Development Strategy and implementing best practice techniques to the evaluation and data recording stages.  

 

 

Quality Risk Management is now at the cutting edge of the Life Sciences industry internationally.  In 2009 the ICH 09 Guideline on the Quality Risk management was incorporated as GMP Annex 20 by the HMRA and EME.  GMP Annex 11 is currently under revision to include a clear reference to a risk based approach for determining the level of validation.