Ⅰ．Benefits of the training
Help enterprises make a better understanding on the specificati*** and regulati*** which are about requirements on special procedure conformation.
Detail introduction about medical device packing, technique of sterilization, materials used in medical packing and packing equipments.
Let people who take part in the training h***e a comprehensive understanding on this field.
Ⅱ. Training objects:
People who are resp***ible for management of the production , technique and quality of sterile medical device and implantable medical device, as well as the people who manage and registering regulati***.
Medical device quality regulatory agencies, people who want to know about special confirmation process, final sterilization packaging, sterilization suitability confirmation, epoxy ethane(EO) confirmation and routine control.
Ⅲ．Training content
1. Sterilization medical device packing training
Related standard regulati***
Common packing forms
Basic principles and requirements
Basic requirements of packing materials
Basic performing experiment on packing system
Effective design methods
2. Training on EO Sterilization confirm
EO sterilization
Introduction on EO sterilization
Technique and regulation challenge
Procedures on sterilization validation
3.Training on routine control
Ⅳ．Training time and place:
Time: September 2012
Place: Guangzhou