Pharmacovigilance QMS & Inspection Preparation

This course is designed to help understand pharmacovigilance Quality Management Systems (QMS) and risk based audits

22-23 Nov 2018

& 9-10 May 2019 , 11-12 Nov 2019

GBP 1,499
EUR 2,099
USD 3,274

Book now

Course overview

Since the introduction of the new pharmacovigilance legislation in the EU, Quality Management Systems (QMS)
and self-audits have become a hot and growing topic. Companies have been increasingly challenged by regulators to implement risk-based audits where con- tinual improvement of processes, systems and compliance to regulations needs to be demonstrated. This is required from the top of the company organisation in all areas of regulatory activity from clinical, regulatory; pharmacoviglance, sales & marketing, IT and medical services.

This course is designed to help in both the assessments of risk and the whole CAPA and preventative action elements.

Who should attend?

QA representatives, EU QPPV and all working in pharmacovigilance, regulatory, clinical and administrators responsible for the management of the CAPA systems.

Programme day one

The audit basics

  • The purpose of an audit
  • Qualifications of the auditor
  • The audit SOP & design
  • The difference between audits and inspections
  • Audit planning and risk assessments

The legislation and audits

  • The requirements to perform company audits
  • In-house versus external audits
  • What needs to be audited
  • Which departments need auditing for safety

Quality Management Systems (QMS)

  • Quality Management Systems – design
  • Quality cycles – expectations and deviations
  • Quality risk assessments
  • Key Performance Indicators (KPIs)
  • Quality failings and corrections

QMS and the audit report

  • The audit scope and conduct
  • The audit report content
  • The grading of audit reports
  • Corrective action plans (root cause
  • Re-audits

Workshop session

Delegates will be provided with information concerning a safety department that has been audited and you have been asked to design the QMS. The safety department in question is the company headquarters safety department based in the EU. You will be asked to devise a plan based upon any risk elements and audit findings identified and look at designing a QMS approach with KPIs. You will also determine what document requests they may make ahead of the audit.

Programme day two

Introduction to PV inspections

  • Background
  • Purpose – design
  • Roles and responsibilities of the licence holder
  • Conduct of regulatory inspections

Risk-based inspections

  • Defining risk
  • Routine and for cause inspections
  • Triggers for an inspection
  • Who should attend the inspection

The pharmacovigilance inspection cycle

  • Pre-inspection questionnaires
  • Site visits & telephone audits
  • Results and CAPAs
  • Inspection follow up questionnaires
  • Follow up Inspections

Workshop session

Delegates will be presented with a series of findings from a regulatory inspection. You will have to look at the findings and work out priorities, devise root cause analyses and provide detailed corrective and preventative action plans which will include QMS activities.

Common findings from regulatory inspections

  • Grades of findings (how to grade findings)
  • How to grade findings in the same PV area
  • Allied findings in other Departments
  • KPIs versus legislation
  • Variations in major authority inspections

Final discussion session


Graeme Ladds

Graeme Ladds, Director of PharSafer, has over 30 years’ experience working in the pharmaceutical industry. Having started his career at Ashbourne Pharmaceuticals in 1989 as Head of Drug Safety & Medical Information, he went on to become Head of Global Pharmacovigilance at Shire Pharmaceuticals. He then set up his consultancy and specialist CRO company, PharSafer Associates Ltd, where he has been involved in establishing pharmacovigilance in companies, performing audits across Europe and the USA, SOP writing, acting as QP for companies, and helping with regulatory inspections.

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22-23 Nov 2018
22-23 Nov 2018 Rembrandt Hotel, London GBP 1,499.00
EUR 2,099.00
USD 3,274.00
+ VAT @ 20.00%
Enrol now
9-10 May 2019
9-10 May 2019 Cavendish Hotel, London GBP 1,499.00
EUR 2,099.00
USD 2,338.00
+ VAT @ 20.00%
Enrol now
11-12 Nov 2019
11-12 Nov 2019 Venue not yet confirmed GBP 1,499.00
EUR 2,099.00
USD 2,338.00
+ VAT @ 20.00%
Enrol now