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Quality Management cyclus (formerly BSDL) - data en feiten
Startdatum Dagen Tijd Docent Locatie Beschikbaar?
13 dagen: JA (17)
6 februari 2012 9.15 Mevr. Dr V.L.C. Moffat Driebergen / Utrecht
7 februari 2012 9.00 Mevr. Dr V.L.C. Moffat Driebergen / Utrecht
8 februari 2012 9.00 Mevr. Dr V.L.C. Moffat Driebergen / Utrecht
16 april 2012 10.00 Dhr. H.W. Frijlink Driebergen / Utrecht
17 april 2012 9.00 Dhr. Prof.dr. H.W. Frijlink Driebergen / Utrecht
18 april 2012 8.30 Dhr. Prof.dr. H.W. Frijlink Driebergen / Utrecht
19 april 2012 8.30 Dhr. Prof.dr. H.W. Frijlink Driebergen / Utrecht
8 oktober 2012 9.30 Dhr. Dr H. van Doorne Driebergen / Utrecht
9 oktober 2012 8.30 Dhr. Dr H. van Doorne Driebergen / Utrecht
10 oktober 2012 9.00 Dhr. Dr H. van Doorne Driebergen / Utrecht
26 november 2012 9.30 Dhr. Drs. A.C.A.J. van de Leur Driebergen / Utrecht
27 november 2012 9.00 Dhr. Drs. A.C.A.J. van de Leur Driebergen / Utrecht
28 november 2012 9.00 Dhr. Drs. A.C.A.J. van de Leur Driebergen / Utrecht

Inhoud

Training Course on Quality Management in Pharma and Biotech 2012

Modules
M 1   Quality Management, the role of the Qualified Person 6 – 8 February 2012                            
M 2   Drug development from Quality by Design to clinical studies: an integrated course for the pharmaceutical industry and hospital pharmacy 16 – 19 April 2012
M 3  Sterile manufacturing  8 – 10 October 2012
M 4   Quality and safety for the manufacturing of biopharmaceuticals: from cell line development to downstream processing and formulation 26 – 28 November 2012

Aim
The course offers an integrated approach on quality management in the pharmaceutical, biotechnological, medical device industries and hospitals to safeguard the quality of their products.
Expert knowledge and real life case studies are combined and presented and coached by professionals from Industry, Universities and Health Care Inspectorates. The training is interactive.

Target Groups
• Professionals in pharmaceutical, biotechnological and medical device industries
• Professionals in institutions and Contract Research Organisations (CRO’s)
• Hospital pharmacists
• Postgraduate students
For (young) professionals in Research and Development, Production, Packaging, Quality Control, Quality Assurance or Regulatory Affairs, who are dealing with the complexity of quality systems, it is important to have an overview of these systems in order to improve quality management in their own environment.

Certificates & Diploma
You can select individual course modules best suited to complement your education or experience. After attending a module, you will receive a certificate for attendance.

In addition, the participants are offered the possibility to complete the modules through an examination. The examination sessions are free of charge and will be scheduled in consultation with the participants.

In combination with a university degree in e.g. pharmacy, biology, chemistry or engineering, and with industrial experience, successful completion of the modules of the training course forms a good starting point to apply for Qualified Person (QP) status.

Accreditation
For hospital pharmacists in the Netherlands: 20 accreditation-hours for each course module attended. (request submitted to NVZA)

Standard Course Fee
The standard fee of Module 1, 3, and 4 is €1500,00.
The standard fee of Module 2 is €1900,00.
The fee includes hotel accomodation, course notes, drinks, lunches and dinners
In the event of cancellation we refer to the general terms of condition of PAOfarmacie
( www.paofarmacie.nl).

Reduced Course Fee
Upon subscription by the same person for the modules 1,2,3 and 4, the total fee is €.4.125,00.
For PhD-students a limited number of fellowships (25 % reduced of the standard fee) is available.
For PDEng-trainees also a limited number of fellowships (25% reduced of the standard fee) is available.

To apply, please send a copy of your registration as a PhD-student or PDEng-trainee to info@paofarmacie.nl

Accreditatie (Uren): 80 (Ziekenhuisapothekers)
80 (Industrie apothekers)
80 (Industrie apothekers / PhD-students)
80 (Industrie apothekers / PDEng -trainees)
Locatie: Hotel Bergse Bossen / Driebergen / Utrecht
Kosten: € 4.125,00 (Excl. 21% BTW)
Doelgroepen: Ziekenhuisapothekers, Industrie apothekers, Overige, Industrie apothekers / PhD-students, Industrie apothekers / PDEng -trainees
E-learning omgeving: Nee