Our Services Our Company News, Media & Resources Contact Us SGS Offices & Labs Skip to Menu Skip to Search Contact Us Websites & Languages Sharing tools Events LIVE WEBINAR: NEW DATA INTEGRITY IN GXP REGULATED LABORATORY ABOUT Join SGS to learn about the criteria for data integrity and how to apply it to your laboratory. Data integrity is a hot topic for regulators and auditors, so avoid the risk of incomplete data, lack of audit trails and falsification of results occurring during inspections. STARTS October 24, 2018, 22:00 ENDS October 24, 2018, 22:00 LOCATION Online AGENDA Data integrity (what/why) Data life cycle management Core data integrity concepts Actions to compliance Case studies Conclusion Q&A BACKGROUND Data integrity is one of the basic GMP principles since multiple data integrity citations were reported by the US Food and Drug Administration (FDA) and European inspectors in the last three years. Many US Warning Letters and EU Non-Compliance Reports deal with serious data integrity violations. Data integrity questions have been and will continue be the focus of many GMP inspections. As a consequence, international authorities – FDA, EMA, PIC/S, WHO, MHRA – have published draft documents to describe the regulatory expectations of data integrity. Although these guidelines are not intended to impose an additional regulatory burden on regulated companies, there is a lot of uncertainty in the pharmaceutical industry on how to implement these requirements into everyday activities. PRESENTER Ioannis Manolopoulos – Life Science Manager, Validation Team Leader TARGET AUDIENCE The webinar is aimed at CSV engineers Laboratory data integrity officers Managers and scientists from analytical development laboratories and quality control Quality assurance personnel Contract research (CRO) and contract manufacturing organization (CMO) laboratory staff and QA personnel Compliance managers and regulatory affairs managers GMP and CMC consultants, GLP auditors and quality consultants Laboratory managers, laboratory supervisors and production managers Auditors (internal and external) responsible for assessing laboratory quality and data integrity Anyone concerned with understanding the importance of data integrity in the audit process DATE AND TIME Thursday, October 25, 2018 2:00 pm Europe Summer Time (Amsterdam, GMT+02:00) Thursday, October 25, 2018 3:00 pm Greece Summer Time (Athens, GMT+03:00) Thursday, October 25, 2018 1:00 pm GMT Summer Time (London, GMT+01:00) CONTACT US SEND A MESSAGE SGS OFFICES & LABS MORE LOCATIONS GET IN TOUCH SGS Headquarters 1 Place des Alpes P.O. Box 2152 1211 Geneva 1 Switzerland T +41 22 739 91 11 F +41 22 739 98 86 E-SUBSCRIPTIONS Sign up to SGS publications and newsletters from your region and around the world. SUBSCRIBE NOW CONNECT WITH US LinkedIn Twitter Facebook SlideShare YouTube Instagram © 2020 SGS SA Terms and Conditions Terms of Access Privacy Cookie Policy Office Directory Careers at SGS Sitemap