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.
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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
Recording from 25.06.2020
Duration of recording: 1,5 h.