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.
Seriously, who will review the Audit Trail Review? First who will execute the Audit Trail Review? An internal Quality role – in the course of the batch by batch execution and review of records, during internal inspections or during an regulatory inspection preparation? Or weekly, bi-monthly or every third batch – or simply just all audit trails created by a system?
And who will analyze in detail and finally judge the results of the Audit Trail Review?
In 2016 a lot of questions were asked about the good old Audit Trail and about the new topic of the so called “Audit Trail Review”. CCS has published a concept paper for an Audit Trail Specification and some considerations for the Audit Trail Review approach.
What is an Audit Trail – in the GMP context of the PQS?
What is the difference of a log and a GMP Data Audit Trail?
What is an Audit Trail Review good for? How often? Why?
What should be reviewed – function or data? What are the results – knowledge management?
Detection of data manipulation? Data Audit Trail or Activity Trail required?
Which data should be audit trailed and which one should be reviewed?
What are CPPs, CQAs, system parameters and/or master data / meta data?
How should a specification look like for a real GMP Data Audit Trail?
Why is the reason for change so important for a real GMP Data Audit Trail?
User roles and concept: Different types for the role Administrator?
GMP documentation with instructions and records vs. electronic data?
What is GMP critical data and knowledge management – on product and process level?
Which roles should be audit trailed and when and if so, how?
Is the Audit Trail Review executed manually or automatically?
You may find some answers or at least ideas for that in the free download provided by CCS below:
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.