1-Day Course: Pharmacovigilance/GCP Audit Report Writing (London, United Kingdom - March 5, 2019) - ResearchAndMarkets.com

January 22, 2019

DUBLIN--(BUSINESS WIRE)--Jan 22, 2019--The “Pharmacovigilance/GCP Audit Report Writing” conference has been added to ResearchAndMarkets.com’s offering.

This course will provide you with practical advice in preparing an effective audit report, to ensure your readers understand the findings and the key messages you are trying to convey. Examples of common issues and pitfalls will be discussed to enable you to improve your audit writing skills.

Audits form an important part of the Pharmacovigilance (PV) and Good Clinical Practice (GCP) quality management systems, and the reports generated provide valuable information to assist companies with maintaining compliance. The audit report is required in GVP Module IV and is a crucial document in communicating compliance risks.

The course will cover the basic principles of how to communicate throughout the conduct of a PV/GCP audit, culminating in the preparation of the final audit report. The expert speakers will give practical advice and examples based on their experiences and there will also be an interactive workshop session.


Writing the audit report

The importance of clear communication to ensure stakeholders understand the issues, why they are important and their impact, and on what basis they have been included Where to start and setting the scene for the findings Drafting the findings Grading the findings - hints and tips Drafting the executive summary - ensuring a balance between detail and attention span QC review - how to conduct, what to look for Post-report communications such as Corrective and Preventative Action (CAPA) support, potential impact on Pharmacovigilance System Master File (PSMF)

Audit communications

Communications before, during and immediately following the audit Ensuring a clear understanding of the objective(s) for the audit before it starts Initial messages following the on-site closing visit/review Communication of the annual audit programme to key stakeholders The audit plan and document requests The on-site opening, daily communications, closing meetings Escalation of significant concerns, early notification of critical findings Post-audit debrief

Workshop: audit report writing

Write audit findings based on scenarios with different PV/GCP issues Rewrite/critique poorly written findings

For more information about this conference visit https://www.researchandmarkets.com/research/c6r6c9/1day_course?w=4

View source version on businesswire.com:https://www.businesswire.com/news/home/20190122005547/en/

CONTACT: ResearchAndMarkets.com

Laura Wood, Senior Press Manager


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Related Topics:Drug Discovery



SOURCE: Research and Markets

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PUB: 01/22/2019 08:39 AM/DISC: 01/22/2019 08:39 AM


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