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Save the date 19th Sept 2017

One-day training in Waterloo
Register online

Save the date: 19TH Sept 2017

Dear members,

Your UPIP- VAPI Board is organizing a one-day course on:

Audit – Regulation and Best Practices

The aim of the training is to put into practice the guideline ISO 19011 to ensure a robust and repeatable audit handling process.
Conducting internal audits (or self-inspections) and external audits of suppliers and outsourcing operations are key elements of a good quality system.
Auditing plays a key role in all three of the objectives: achieve product realization, establish and maintain a state of control, and facilitate continual improvement.

For this training, we have decided to collaborate with CVO-Europe, which provides training in Europe for Pharmaceutical and Medical device companies.

What are the advantages for you?

  • Senior tutor with extensive experience in industry Mr Frederic Lombardo, will lecture our course.
  • He is senior quality manager with more than 15 years of experience in Operational QA as well as global Quality Systems for different international large Health care groups with a leading role, focusing on constant improvement and creativity, who can adapt his personal style to get the message across.
  • Focus on real "on the field" situations in the pharmaceutical industry without being too academic It also includes games.

What additional benefits can you expect from VAPI-UPIP?

  • A professional course organized in Belgium, close to you.
  • Reduced price for our members.
  • VAPI-UPIP, as non-profit professional association, offers this 1-day course for 645 € for its members and 795 € for non-members.
  • Unique chance to build your network beyond the boundaries of your own company.

 

What You Will Learn

The aim of this course is to highlight the methods & tools of Audit to ensure consistently robust Quality and repeatable Compliance.

 

Training Topics & Objectives:

  •    Audit Regulatory perspective
  •    Crucial aims of an efficient audit procedure
  •    Characteristics of a successful auditor
  •    Auditing as a component of a Pharmaceutical Quality System
  •    Performance indicators of audit handling
  •    Inspection readiness

Who should attend?

Manufacturers, wholesalers, brokers, CRO’s & CMO’s involved in commercial & clinical supplies.

This course is aimed at managers and personnel involved in departments responsible for:

  • Manufacture  
  • Storage and distribution of (investigational) medicinal products  
  • Quality 
  • Release - QP 
 

Booking information

Audit – Regulation and Best Practices

19th Sept 2017

Venue: 

161 Drève Richelle, building I - 1410 Waterloo 

+32 (0) 2 389 15 13 – for map  www.cvo-europe.com

  • VAPI-UPIP member            645€ (incl. VAT) 
  • Non VAPI-UPIP member     795€ (incl. VAT)

Included: Tuition, course notes, attendance certificate, sandwich and refreshments.

Excluded: Hotel accommodation and dinner

Training begins at 08h30 and finishes at 17:00

 

Please register Register online

or  by email to This email address is being protected from spambots. You need JavaScript enabled to view it. with the registration form.

 

  Training Agenda:

  • Introduction of the audit handling process
  • The international regulations
  • The characteristics of a good auditor (game)
  • The main objectives of the audit
  • The audit procedure & process (game & role playing)
  • The audit follow up
  • The inspection readiness (ex: FDA inspection)

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UPIP - VAPI

We are a platform for all pharmacists active in the pharmaceutical industry and for those interested in its activities. The organisation has over 300 members from all branches of the pharmaceutical industry.

  

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Our Greenbook here

 

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