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 Requirements
For our webinars, we use Cisco WebEx, one of the leading suppliers of online meetings.
At http://www.webex.com/test-meeting.html you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in. Please just enter your name and email address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.
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