Presenter: Ejaz Butt

Transcription

1 Presenter: Ejaz Butt

2 Disclaimer The content and opinions expressed in the following PowerPoint slides are those of individuals who prepared the presentation and should not be attributed to Zigzag Associates Ltd These PowerPoint slides are the intellectual property of the individual presenter and are protected under the copyright laws. Used by permission. All rights reserved

3 Background Emergence of defined pharmacovigilance regulatory requirements on auditing. Increasing burden on resourcing. The remote auditing approach: low risk auditable entities; high risk geographical locations. Remote auditing: specialised questionnaire in depth telephone conference discussion review of documentation

4 PV Audit Definition According to EMA GVP Module IV an audit is a systematic, disciplined, independent and documented process for obtaining evidence and evaluating the evidence objectively to determine the extent to which the audit criteria are fulfilled, contributing to the improvement of risk management, control and governance processes

5 PV Remote Audit Definition The conduct of a PV audit without being present on-site E.g. the audit may be conducted via telephone, teleconference, videoconference or WebEx

6 Reasons for conducting PV Remote Audits Pandemics, natural disasters, high criminality areas at the audit location Travel security issues at the audit location Transport restrictions to the audit location Remote vs. on-site approach selected for low risk parties Narrow audit scope Financial restraints

7 EMA Guidance - Distant/virtual PV inspections of MAHs during a crisis situation Points to consider document published 18 January 2013 EMA inspectorate guidance on conducting distant/virtual PV inspections Distant/virtual inspections follow existing guidelines as for PV inspections Document outlines the specificities of distant/virtual PV inspections

8 PV Remote Audit Audit Planning & Preparation Auditor s Perspective Audit scope & objectives clearly defined in audit plan Facilities tour agreed in advance Questionnaire with targeted document requests Auditees provided with sufficient notice of the audit Audit timings - consider all applicable time zones

9 Technology Technology testing Back up options PV Remote Audit Audit Planning & Preparation Auditor s Perspective

10 PV Remote Audit Audit Planning & Preparation Auditor s Perspective Review of documents Documents exchanged e.g. Document Repository, SharePoint A back-up process Documents retrieval will be lengthy process Allocate time for document reviews in your audit agenda

11 PV Remote Audit Audit Conduct Auditor s Perspective Questions during the opening meeting Explanation for reasoning of the remote approach Ensure you speak clearly & slowly Repeat & summarise information on concluding an interview to confirm the auditees understanding

12 PV Remote Audit Audit Conduct Auditor s Perspective Maintain control of the audit Resolve technology issues promptly Keep the auditees informed of the progress Update the auditees for any timing changes Any additional discussions ad hoc Providing regular feedback

13 PV Remote Audit Audit Conduct Points To Consider for Auditees On site vs Remote preparations E.g. Staff training SOPs are up-to-date Training records, CVs & job descriptions are up-to-date QA representative present/available

14 PV Remote Audit Audit Conduct Points To Consider for Auditees Specific considerations for remote audits: Testing technology Document exchange testing If any issues are identified whilst testing any of the above, inform the auditor immediately

15 PV Remote Audit Audit Conduct Points To Consider for Auditees Specific considerations for remote audits: Arrange translator if applicable Ask questions Be flexible

16 PV Remote Audit Audit Reporting & Follow-Up Auditor s Perspective Audit close out and reporting Schedule ad hoc additional meeting Same approach as onsite Issue the audit report & follow-up as required

17 PV Remote Audit Quality Management System The Auditing SOP should stipulate the Company s standards to be followed for the conduct of remote audits Ensuring remote audits are covered in the Auditing SOP will help with consistency in the conduct of such audits

18 Advantages PV Remote Audit Advantages vs Allows conduct of audits in locations where onsite audits would not be possible No travel administration or costs Can be conducted from any location Can be rescheduled with more ease than on-site audits as travel plans do not need to be considered Can be used as a training opportunity for junior auditors Multiple stakeholders can participate in the audit with ease vs. on-site audits Various technology available for conduct of audit, e.g. teleconference, videoconference, WebEx Disadvantages Disadvantages Difficulties in setting up audit interviews due to varying time zones of the auditor vs. the auditees Issues with technology when sharing documents Takes longer sharing documents virtually vs. onsite Auditor unable to see the auditees body language, facial expressions Language differences are harder to manage remotely vs. on-site- harder for auditor to build relationship with auditees Costs involved with using technology Technology may fail during audit conduct

19 References Last Accessed on 16 March 2016: eline/2015/08/wc pdf eline/2013/02/wc pdf Remote-Auditing-in-Maintaining-Effective-Pharmacovigilance-System- Oversight/

20 Questions?