Your will get familiar with the current regulatory requirements on data integrity and how regulators refine these requirements
You will get a deeper understanding what FDA and European inspectors expects from pharmaceutical companies in regard to Data Integrity
You will learn how to implement the (new) regulatory requirements on Data Integrity into your Pharmaceutical Quality System
You will learn how to prepare your company for a successful inspection in regard to Data Integrity
You will understand how to establish an effective Data Governance System
You will learn how to investigate Data Integrity issues in your company
Background
Even Data Integrity is one of the basic GMP principles since years multiple Data Integrity citations 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 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.
Although all guidelines are not intended to impose additional regulatory burden to the regulated companies, a lot of uncertainty predominates the pharmaceutical industry how to implement these requirements into the daily business.
Target Group
The courses are directed at
Managers and staff from Manufacturing, QC/QA and Analytical Development Laboratories of pharmaceutical companies
Contract Research Organisation and Contract Manufacturing Organisation manufacturing, laboratory and QA personnel
Auditors (internal and external) responsible for performing self-inspections or external audits and needing to understand and assess data integrity
Especially the Data Integrity Master Class course is directed to participants who have first experiences in Data Integrity, e.g. the ECA course “Data Integrity – Requirements for a GMP compliant Data Life Cycle".
For Attendees Only
Attendees will get a free electronic copy of ECA “GMP Data Governance and Data Integrity Guide” - Version 3
To find alternative dates for this training/webinar or similar events please see the complete list of all events.
For many training courses and webinars, there are also recordings you can order and watch any time. Just take a look at the complete list of all recordings.
Testimonials
Seminar Programme as PDF