• Facebook
  • Twitter
  • LinkedIn
  • Google +
  • RSS

Assuring data integrity; best practice

JPAGlogo_hires_LDate: 16 March 2017

Location: Royal Society of Chemistry, Burlington House, Piccadilly, London W1J 0BA

Email: events@jpag.org 

Website: http://www.jpag.org/82

Event Description:

Data integrity is receiving much attention in the pharmaceutical industry, with several high profile cases where deficiencies have resulted in regulatory action, and the MHRA, FDA, EMA and WHO have all issued guidance documents recently.
These guidance documents draw together the requirements of predicate rules and point the industry towards better practices in the life-cycle management of data records, from initial validation of data management systems, through daily operations, to long-term retention and archival practices.

Although the scope is primarily support of GMP, the MHRA has recently drafted guidance for GLP, GDP and GCP, which applies the same standards across these related activities.

This symposium will bring together experts from Health Authorities, pharmaceutical companies, CROs and technology -providers to discuss the approaches being taken to rise to the challenge of increased scrutiny of data management practices. Particular focus will be given to the changes that need to be implemented, and to the consequences for a GMP manufacturing organisation if it does not assure data integrity.

Registration starts at 9.30 and the symposium starts at 10.00

Leave a reply

 

Webinar: Understanding ISO Standards: ISO 14644-2:2015 Cleanroom MonitoringFIND OUT MORE
+ +