Special lectures on clean workshops for terminally sterilized medical device production | Online training | Jinnan Testing
22-09-02 16:29
Special lectures on clean workshops for terminally sterilized medical device production | Online training
September 23, 2022
Dear Customer: Hello:
Thank you and your team for your long-term support for Jinnan Medical Testing business!
The design, construction, acceptance, standardized management and daily monitoring of clean room workshops play a vital role in the production quality control, quality management and product risk management of enterprises. Medical device manufacturers can improve the management quality of clean workshops by understanding the relevant legal and regulatory requirements for clean workshop construction and acceptance, as well as the problems that are likely to occur during clean workshop inspections, thereby ensuring the production environment of products.
In order to further improve the standardized management capabilities of medical device companies for the production of clean workshops, an online sharing session related to the " Special Explanation of Terminally Sterilized Medical Device Production Clean Workshops" is held, and you are sincerely invited to participate!
The specific meeting schedule is as follows:
1. Conference organization
Shenzhen Jinnan Medical Testing Technology Co., Ltd.
Shunwei Environmental Technology (Shenzhen) Co., Ltd.
Shenzhen Jinpai Medical Packaging Sterilization Service Co., Ltd.
Dongguan Anbao Medical Packaging Technology Co., Ltd.
2. Meeting time
September 23, 2022 14:00-17:00
3. Meeting method
live online
4. Contents of the meeting
| time | training content |
14:00-15:30 (Teacher Liu) | 1) Environmental selection of production area and design requirements of environmental parameters 2) Process design and architectural design 3) Air purification 4) Acceptance requirements after construction is completed 5) Maintenance of clean workshop |
15:30-17:00 (Teacher Zhang) | 1) Introduction of domestic and foreign standards for clean room testing 2) Clean room pollution source 3) Clean room environment control 4) Daily monitoring of clean room |
5. Conference explainers
Teacher Liu
Major in clinical medicine, engaged in the establishment of quality system and process verification in the pharmaceutical industry for many years;
Proficient in the design and maintenance of clean workshops related to sterile medical devices, and the verification and confirmation of medical device production processes;
Proficient in all standards related to the pharmaceutical industry such as ISO13485, GB50457, YY0033, and on-site inspection guidelines for the quality management of medical devices;
Currently serving as the technical manager of Shunwei Environmental Technology (Shenzhen) Co., Ltd.
Teacher Zhang
Master of Microbiology
Engaged in medical device related testing and laboratory management for many years;
Proficient in microbial testing and clean room testing related to sterile medical devices;
Proficient in all international and domestic standards related to testing, such as GB, ISO, etc.;
Proficient in the quality control and evaluation criteria of sterile medical devices;
Currently serving as the laboratory manager of Shenzhen Jinnan Medical Testing Technology Co., Ltd.
6. Participants
Enterprise technology research and development personnel, inspection personnel.
7. Contact registration method
1. Training contact: Mr. Zheng/Jinnan Testing Marketing Department
2. Registration phone number: 19129490661/13923648758 (same number on WeChat)
3. Registration email: ks09@kingservice-ps.com
4. Registration method:
More news
Notice of the General Department of the State Food and Drug Administration on Printing and Distributing the Work Procedures for the Inspection of the Quality Management System for the Registration of Class III Medical Devices in China
Water quality testing
Water quality testing and testing indicators
Current status and development of medical device testing
Quality Control Measures of Medium in Microbiological Testing
Clean room testing methods and procedures
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