Data Integrity in the Light of ICH Q7 - Webinar Recording
Course No. 18078A
Speakers
Dr. Markus Dathe
F. Hoffmann-La Roche
Background
Data Integrity has become the major regulatory concern with Regulatory Agencies who have issued several guidance documents which focus on computerized systems, data governance and data. Even though drug products are often in the focus of Data Integrity audits and inspections, Data Integrity compliance is likewise required for Active Pharmaceutical Ingredients (APIs). The ICH Q7 guideline provides information especially for the GMP-compliant manufacturing, documentation and handling of Active Pharmaceutical Ingredients (APIs) as well as Data Integrity requirements.
Target Group
This webinar is designed for all persons involved in Data Integrity processes related to the manufacture and GMP compliant documentation of APIs, especially for persons from Production, Quality Control, Quality Assurance , Technical and Regulatory Affairs departments as well as for Qualified Persons and Auditors.
Technical Details:
To participate in an on demand training course or webinar, you do not need any software. The recordings are made available via a streaming server. In general, the recording is provided in MP4 format, which any PC (Microsoft Windows, Apple IOS) or tablet can easily display.
Timing and Duration:
When you register for the on demand Training course or webinar you can decide at what date you want to follow the training course online. For a 1-day training course you will have 2 days in which the stream is available (for 2-day training course 3 days and for a 3-day training course 4 days). Within in this timeframe you can start & stop the stream according to your needs.
In time before the scheduled date (your desired date) you will receive an e-mail from us with a link for direct participation as well as your log-in data.
Training Course Documentation and Certificate:
The presentations will be made available as PDF files via download shortly before the online training course. After the event, you will automatically receive your certificate of participation.
Programme
This webinar will give you a comprehensive overview of the Data Integrity requirements for APIs laid down in the ICH Q7 guideline. Risk-based approaches as well as interpretations will be discussed and explained.
Which requirements are applicable to APIs under ICH Q7?
Specific Requirements and Interpretations
Consideration for specific risks
The hubris of hybrid records
Case study: how to achieve Data Integrity on a risk-based approach
Testimonials