Séminaire Microbiologie Montréal 11 sep.

[<microbiology@sympatico.ca>]

Inscription gratuite sur le site de National Pharmaceutical Sciences Group 
Canada -

http://www.psg.ca/index.php?task=courses&courseid=00000318

Free Seminar Montreal - en FRANÇAIS - mardi 11 septembre 2007 à 19.00 heures

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Date: Name: Location
Tuesday, September 11, 2007
7:00 PM TO 9:00 PM

(Registration 6:30 PM) La simulation des procédés aseptiques par remplissage 
aseptique ?
réglementation et BPF

HOTEL Holiday Inn Pointe Claire -  6700 Transcanada Hwy
Pointe Claire, Quebec - 514-697-7110
Fees:  Registration Link:  Registration Deadline
PSG Member: $0.00 + $0.00 GST = $0.00
Non-Member: $0.00 + $0.00 GST = $0.00
 Friday, September 7, 2007
Course Objective:

Course Description:

The following topics will be discussed:

-   CFR, FDA,and Health Canada Regulations
-   Buildings and Facilities
-   Personnel ? (qualification, training, monitoring)
-   Components and container/closures
-   Bacterial Endotoxin Control ? video
-   Validation of Aseptic Processing
-   Process simulation (Media fill program)
-   Size of runs and Interpretation of tests results
-   Filtration and sterilization
-   Laboratory controls
-   Sterility Testing USP- investigation and interpretation of positives
-   cGMP for Sterile Drug Products produced by Aseptic processing

Course Leader:

Vania Atudorei and Ludovic Mathieu-Moulin

Vania Atudorei has over twenty five years experience in pharmaceutical 
microbiology in Europe and North America. He has experience working in 
manufacturing, quality assurance and quality control, training and 
management in both the pharmaceutical and food industry. He teaches at 
Gerald-Godin College in Montreal in pharmaceutical technologies of sterile 
products and Guelph University - Alfred Campus in Food Industries and HACCP. 
Vania is a member of the French Microbiological Society, Quebec 
Microbiologists Association and a consultant for the Canadian International 
Development Agency and World Bank for international projects in developing 
countries in Africa. He has experience in pharmaceutical, clinical, food and 
environmental microbiology completed with studies in the graduate program 
for Pharmaceutical Products Development at Pharmacy Faculty of Laval 
University. Vania has lectured in many countries, colleges and Universities 
and pharmaceutical companies for continuing pharmaceutical education for GMP 
and sterile manufacturing and quality sterile products. Presently he is 
General Manager for STERIGEN Inc., a sterile pharmaceutical manufacturing 
company.

Ludovic Mathieu-Moulinis a microbiologist and works as an analyst in a 
pharmaceutical microbiology laboratory. Ludovic is a graduate of Montreal 
University, and a violinist in Young Symphony Montreal Orchestra and student 
in Management at HEC.


Who Should Attend:
Personnel from Production, Quality Assurance, Quality Control, Training, and 
Validation.