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
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)