The Conference is designed for all Qualified Persons and aspiring Qualified Persons. It also addresses upper management functions and authority representatives who want to be informed about the latest development regarding the duties and responsibilities of Qualified Persons.
29. and 30. September 2017
Venue Best Western Hotel M 56a Bulevar Oslobođenja Street, Belgrade
You will understand the purpose and organisation of regulatory inspections and you will learn how to prepare your company to pass an inspection or customer audit and how to assure the most positive outcome.
Get practical knowledge of:
What inspectors are looking for
Successful preparation and management of Inspections
Typical compliance issues and proactive compliance
Die Datenintegrität der GMP-Daten ist ein zentrales Inspektionsthema. In diversen US FDA Warning Lettern als auch EMA GMP Reports werden bereits entsprechende Mängel dargestellt. Im Seminar lernen Sie die Anforderungen an die Datenintegrität kennen und Sie erfahren die aktuellen Richtlinien und Inspektionsergebnisse.
comes compliance services (CCS), a leading GXP consulting service provider, for Pharmaceutical Quality Systems, Data Governance and Integrity, Computer System Validation and Inspection Readiness Programs, today announced that it has acquired more than 100 business customers since the launch of its services in 2009. Pharmaceutical and Medical Device customers rely on the compliance and consultancy services since many years provided by CCS. About 80 % of CCS projects are repeat-business and sales continue to ramp steadily. Continue reading “CCS – 100 – business customers reached in 2016”
The European Medicines Agency (EMA) has added to the GMP Q&A blog the topic “Data Integrity”. The agency states that the questions should be read in conjunction with Eudralex Volume 4 (GMP guidelines). Find all 23 of the questions and answers via the following link.
PIC/S has published on a draft basis a guidance on Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments (PI 041-1 (Draft 2)) developed by the PIC/S Working Group on Data Integrity. This draft guidance will be applied on a 6-month trial basis by PIC/S Participating Authorities. This draft document results from the need among Inspectorates to have access to harmonised data integrity guidance, considering the impact to public health. The purpose of the trial-period is to learn from implementation. It is acknowledged that the guidance requires expanding in some areas; however, the document has value in describing foundational principles which can be enhanced in future revisions. This draft document is not open for comments by industry. Formal adoption of the guidance will proceed in accordance with PIC/S procedures – including a stakeholders’ consultation – on a revised version after completion of the trial-period.