Reasons to attend
This course on remote auditing will provide you with awareness of essential concepts, tools and some practical approaches to allow you to plan and conduct effective remote audits achieving their full potential and objectives without detriment to their integrity and validity.
The course will focus on the risk-based audit concepts, remote audits of clinical service providers and clinical investigator site audits.
- Documents and materials related to this course are included
- Globally recognised certificates awarded after test completion
- This course has been granted PharmaTrain Recognition
The COVID-19 pandemic and the accompanying restrictions on travel and on-site visits are just one set of exceptional circumstances that can force sponsors to re-evaluate their annual audit plans. Remote audits are a trend that is gaining traction rapidly and expansion of this evolution of auditing methodology can only be a helpful phenomenon.
New information and communication technologies (ICT) have made remote auditing more feasible. Modern ICTs open the opportunity to audit sites and systems remotely adding advantages that can offset some of the disadvantages of onsite audits. Such advantages include shortening distances, travel time and costs, reducing the environmental impact associated with audit travel, adapting audits to different organisational models. Remote auditing can help to increase the size or quality of sampling in the audit process, when prepared, validated, and used appropriately. The use of Remote Auditing also allows for the inclusion of expertise (Subject Matter Experts (SMEs) in an audit that otherwise might not be possible due to financial or logistical constraints.
Notwithstanding the benefits of remote auditing, any limitations must be identified and addressed against the fulfilment of audit objectives. Such limitations may include information security, data protection and confidentiality issues, authenticity and quality of the objective evidence collected, amongst others.
The decision on how to handle each individual audit, whether it is to be a postponement, re-moval from the audit plan altogether, or conduct of a full or abbreviated remote site audit must be justified and documented by QA.
This training provides you with the first introduction to key Risk-Based Remote Auditing terminology and concepts as well as practical guidance and recommendations for the planning and conduct of remote audits of GCP- and GVP-governed processes, systems, and service providers.
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