Zurich, Switzerland: +41 - 43 434 80 33   |   US: (510) 962-8903   |   support@traininng.com

Seminar Price Details

Seminar Fee for One Delegate
Price : US$1,199.00

Register for 5 attendees
Price : US$5,995.00

Register for 10 attendees
Price : US$11,990.00



**Please note the registration will be closed 2 days (48 Hours) prior to the date of the seminar.
  • Course Description
  • Agenda
  • Price
  • Speaker
  • Venue

Overview

The delegates will be provided with information concerning a Safety Department they have been asked to audit. The safety department in question is the Company Headquarters Safety Department based in the EU.
The delegates will be asked to devise an audit plan based upon any risk elements they have identified. The delegates will also set up what document requests they may make ahead of the audit.

Who Will Benefit

  • Anyone involved in Pharmacovigilance
  • Regulatory
  • Clinical
  • Quality Assurance
  • Compliance
  • EU QP PVs will benefit from this course.

Agenda

Day 1 Schedule

Lecture 1: The Audit Basics

  • The purpose of an Audit
  • Qualifications of the Auditor
  • The Audit SOP & Design
  • The difference between Audits and Inspections

Lecture 2: Quality Management

  • Quality Planning
  • Quality Systems
  • Quality Cycles
  • Quality Risk Assessments
  • The Quality Risk Assessment

Lecture 3: 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

Lecture 4: The Audit & Report

  • The Audit scope and Conduct
  • The Audit Report content
  • The grading of Audit reports
  • Corrective Action Plans (Root Cause Analyses)
  • Re-Audits

Practical Exercise

The delegates will be provided with information concerning a Safety Department they have been asked to audit. The safety department in question is the Company Headquarters Safety Department based in the EU.
The delegates will be asked to devise an audit plan based upon any risk elements they have identified. The delegates will also set up what document requests they may make ahead of the audit.

Lecture 5: The Audit Cycle

  • Audit Frequencies
  • Routine and For Cause audits
  • Audits and legislation changes
  • Company versus Distributor audits
  • Audits and Inspection findings

Day 2 Schedule

Lecture 6: Introduction & History of PV Inspection

  • Background
  • Purpose
  • Roles and responsibilities of the license holder
  • Conduct of Regulatory Inspections

Lecture 7: Risk Based Inspections

  • Defining Risk
  • Routine and For Cause Inspections
  • Triggers for an Inspection
  • Who should attend the Inspection

Lecture 8: Pharmacovigilance Inspection Cycle

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

Practical Exercise

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 actions.

Lecture 9: Common findings from Regulatory Inspections

  • Grades of findings (how to grade findings)
  • How to grade findings in the same PV area
  • Allied findings
  • Variations in Major Authority Inspections

Lecture 10: Questions from any part of the course

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Group participations

Get fabulous discounts by participating in groups of two or more.

No Attendees Discount
1 2 Attendees 10% off
2 3 to 6 Attendees 20% off
3 7 to 10 Attendees 25% off
4 10+ Attendees 30% off

To avail the above group discounts, all the participants should register by making a single payment

Call our representative TODAY on +41 - 43 434 80 33 to have your seats confirmed!

Graeme Ladds 

CEO,
PharSafer Associates Ltd


Dr. Graeme Ladds has been involved in Drug Safety for the last 30 years. Graeme has been working as Head of Global Pharmacovigilance and EU QP PV for many large (and small) Pharma, and has been CEO for the last 15 years for PharSafer. His previous role in industry was Head of Global Drug Safety at Shire Pharmaceuticals.

Fifteen years ago, Graeme set up his own consulting Company PharSafer Associates Ltd, a niche CRO providing both Clinical and post marketing drug safety and medical information services to the Pharma industry globally, from total outsourcing of Safety and Medical Services to bespoke projects and interim requirements. Based in the UK, the Company performs full safety services for companies from the USA, Canada, India, Europe and Japan and has been inspected on site by the Regulators and clients. PharSafer employs science graduates, pharmacists, physicians all with varied and extensive pharmacovigilance experience.

Venue

Location: London, UK
Hotel: London Hilton on Park Lane