Bernd Bödecker, Recently retired EU-GMP Inspector (Trade & Industry Inspection Agency Hannover)
One important part of a supplier qualification process is the performance of an on-site audit. Currently, because of the Corona crises, the fact that an auditor has to visit a site presents a potential risk to all persons involved or might simply not be possible because of travel bans.
If an on-site audit is not possible, a risk-based supplier qualification process can be supported by a remote or virtual audit. Such an audit may be conducted through various communication channels such as video calls or other appropriate tools available. Many inspectorates, including FDA, MHRA and from EU have started to utilise remote paper based inspection approaches.
But it needs to be well-prepared from both, the auditor and the auditee.
GMP Auditors from Pharmaceutical and API Industry and those who are involved in preparing, managing and escorting audits and inspections.
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.
Get a detailed overview of the possibilities and limits of a remote or virtual audit. Both perspectives will be considered, that of the auditee and that of the auditor:
- Legal background
- Methods & tools for distant assessment of suppliers and service providers
- Pros & cons of remote audits
- Reliance of QPs on results of remote supplier audits for batch certification
- Integration of remote auditing into the customer‘s QA system
- Risk-based selection of suppliers for remote audits
- Risk-based design of remote audits
- Auditor and auditee preparing for a scheduled remote audit
- Conducting the audit & follow-up