Every pharmacovigilance function will, at one time or another, undergo governmental or health authority inspections as well as audits by license partners, internal auditors and others. The course will teach you how to prepare for an audit / inspection from the time of the receipt of the announcement (or of the arrival of the inspectors at your doorstep) to the conclusion of the audit or inspection.
Who Should Attend
Professionals who work in:
- Pharmacovigilance / Drug safety (QPPV)
- Regulatory Affairs
- Quality & Compliance
- Information Technology
- Medical Information
- Risk Management
- Pharmacovigilance Auditors
- Management Staff Responsible for Running Inspections
- Employees (directly and indirectly) Involved in Inspections
For professionals with 2-3 years of experience in pharmacovigilance this course will be at an intermediate level; professionals with experience from the auditing area will find this course to be at a beginner level.
At the conclusion of this course, participants should be able to:
Participate in audits / inspections and mock audits / inspections
Assess how to handle the actual audit / inspection and responses to requests and findings based on the
- understanding of audit / inspection methodology
- the legal basis of inspections or
- the contractual basis of audits and
- the appreciation of regional differences
Prepare responses to audit / inspection findings, including responses and corrective/preventive action (CAPA) plans
Prepare their function for an audit / inspection: roadmap, teams, tasks, and documents
Assess regional differences with respect to European and US FDA inspections
Participants will complete a knowledge check at the end of the course and will be provided with feedback to ensure learning objectives are attained.
Hotel & Travel
DIA has blocked a limited number of rooms at the following hotel:
Hotel Novotel Paris Charenton
3-5 place des Marseillais
94227 CHARENTON LE PONT
at the rates of EUR 150.00 per room inclusive of breakfast and exclusive of VAT.
To make your reservation please use the hotel booking form.
Important: The room rate is available until 22 September 2014 or until the group block is sold-out, whichever comes first.
In case of cancellation: The room can be cancelled 43 hours prior arrival, after that the credit card will be charged for the 1st night.
The Hotel Novotel Paris Charenton is located 10 minutes from Gare de Lyon train station, the vibrant Bastille district & Bercy. The liberté metro station (line 8) opposite the hotel gives direct access to Paris's main attractions like Place de la Concorde, Eiffel Tower, Opéra, etc.
DIA Europe, Middle East and Africa
Phone.: +41 61 225 51 51
Fax: +41 61 225 51 52
Monday-Friday 8:00-17:00 CET
Agenda and Event Logistics
Gunta Sveke, Event Manager
Phone: +41 61 225 51 55