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.
5 Mar 2019
& 16 Sep 2019
GBP 699 599 *
EUR 979 839 *
USD 1,090 934 *
* When you book before 21 Jan
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.
Benefits of attending:
The course is designed for those personnel involved in the conduct and writing of PV/ GCP audits, and those who are responsible for performing QC review of PV/GCP audits. This includes Quality Assurance auditors in PV or GCP, and supporting personnel such as QA management and training. The course would also be useful for personnel conducting compliance assessments in PV/GCP.
Writing the audit report
Workshop: audit report writing
Helen Powell (5 Mar 2019)
Helen Powell has over 30 years’ experience in the pharmaceutical industry in large pharma, CRO and consultancy sectors. She brings significant expertise in auditing (GCP, PV and auditing of corporate legal risks), has managed global audit teams across the USA, Asia Pacific and Europe, as well as facilitating PV and GCP inspections in these territories.
Pam Bones (5 Mar 2019)
Pam Bones has more than 20 years’ experience in the area of pharmacovigilance (PV). She began her career in operational PV, as a case processor for large pharma, before moving to begin a PV QA career. Since that time, Pam has held a number of positions in PV QA for large and medium pharma with the most recent post as Director of the Global PV QA department for Allergan. Pam now provides PV QA services (including audit, auditor training and inspection readiness) for a variety of clients through her consultancy company, Rigg UK Consulting Ltd.