Live Online Training: Distant Assessments/ Remote Audits - what you need to know
17/18 May 2021
Course No. 18972
Speakers
Dr Jean-Denis Mallet
Former Head of the Pharmaceutical Inspection Dpt. AFSSAPS
Katja Kotter
Vetter Pharma-Fertigung
Dr Anke von Harpe
QProgress
Dr Rainer Gnibl
GMP Inspector
All times mentioned are CET.
Objectives
Get a detailed overview of the possibilities and limits of a Distant Assessment/ Remote Audit. Both perspectives will be considered, that of the auditor/ inspector and that of the auditee.
Background
One important part of a supplier qualification process is the performance of an on-site audit. Currently, because of the situation with the worldwide pandemic situation, site visits present a potential risk to all persons involved or might simply not be possible because of travel restrictions.
If an on-site audit is not possible, a risk-based supplier qualification process can be supported by a Distant Assessment. Such an assessment may be conducted through various communication channels such as video calls or other appropriate tools available.
Also many inspectorates from EU and other regions of the world have started to utilise Distant Assessment approaches.
But it needs to be well-prepared from both, the auditor and the auditee.
Target Group
GMP Inspectors and GMP Auditors from Pharmaceutical and API Industry and those who are involved in preparing and managing Distant Assessments, audits and inspections.
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.
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.