This workshop will cover the regulatory requirements and present approaches and practical experiences on the implementation of data integrity strategies in microbiological laboratories. It will provide you the possibility to discuss the challenges of the ongoing automation of methods and processes in relation to the increasing requirements of data integrity.
Even Data Integrity is one of the basic GMP principles. Multiple Data Integrity issues were reported by FDA und European inspectors during the last 3 years. Many US Warning Letters and EU Non-Compliance Reports deal with serious Data Integrity violations. Data Integrity questions have been and will continue to be the focus of many GMP inspections.
As a consequence, international authorities – FDA, EMA, PIC/S, WHO, MHRA - published draft documents to describe the regulatory expectations of Data Integrity.
Even though the guidelines are not intended to impose additional regulatory burden upon the regulated companies, a lot of uncertainty predominates the pharmaceutical industry about how to implement these requirements into the daily business.
For more information and registration visit: www.microbiology-conference.org