Sterilization Medical Device Packing,EO Sterilization Confir

Sterilization Medical Device Packing，EO Sterilization

Confirm and Routine Control Training

Ⅰ．Benefits of the training

Help enterprises make a better understanding on the specifications and regulations 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 have a comprehensive understanding on this field.

Ⅱ. Training objects:

People who are responsible 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 regulations.

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 regulations

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, specific time is undetermined

Ⅴ．Introduction of organizers

Guangdong Medical Device Quality Supervision and Test Institute Guangdong Medical Device Quality Supervision and Test Institute was founded in1988, directly affiliated institution of Food and Drug Administration, the only national medical equipment inspection

institution in southern China as well as the medical device equipment quality supervision and inspection laboratory which is appointed by the State Food and Drug Administration. It performs the duties of Guangdong province quality supervision and medical equipment testing stations and Guangdong medicine packing product quality supervision and inspection offices. It is also responsible for the quality supervision and inspection in the state, provinces and districts, at the same time , it is the national compulsory CCC certification of products designated testing laboratory and inspection laboratory of CE authentication products authorized by Germany TUV PS

Medical Device Quality Management Committee, China Quality Association for Pharmaceuticals

Medical Device Quality Management Committee, China Quality

Association for Pharmaceuticals is a commonweal social organization which is registered by Ministry of Civil Affairs. As the assistant of developing medical device quality management, it is a science and technology organization which is taken part in by people who focus on the management of medical device , as well as to help government contact with pharmaceutical enterprises. It is undertaken by China Quality Association for Pharmaceuticals and it is affiliated to Guangdong Medical Device Quality Supervision and Test Institute.

Osmunda Medical Device Consulting Organization

Osmunda Medical Device Consulting Organization which focuses on professional consulting in the field of medical device , founded in 2004, has set up seven wholly owned subsidiaries in Guangzhou, Beijing, Shanghai, Suzhou, Shenzhen, Jinan and America. We are able to provide fully

solutions to medical device manufacturers, including marketing research, technical and capital services, workshop selection and design , clinical trail , quality system establishment , third party audit and global marketing approval.

The training certificate is issued solely by Guangdong Medical Device Quality Supervision and Test Institute, Medical Device Quality Management Committee, China Quality Association for Pharmaceuticals and Osmunda Medical Device Consulting Organization.

Sign up please contact:

Osmunda Medical Device Consulting Organization

Contact: Miss Ma, Tel: 020-62321333- 607 / Fax:020-62327856

Email: olivia.ma@

Miss Xie, Tel: 020-62321333- 622/ Fax:020-62327856

Email: xuan.xie@

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