All relevant units:
The quality of final sterilization medical devices is related to the health and safety of patients and patients. Medical device quality inspectors play a crucial role in product quality control. How medical device enterprises control product quality and establish a compliant medical device testing system is an important quality management link for every enterprise.
In order to further improve the microbiological control level and product testing ability of medical device enterprises in the production process, guide microbiological inspection personnel to establish product bioburden and sterility test operating procedures, standardize operating techniques, and comprehensively enhance the theoretical knowledge and practical skills of inspection personnel, this training course is specially held. After the training, a certificate of qualification for the training of medical device microbiological inspectors will be issued. The relevant matters are notified as follows:
1、 Organizational structure
Shenzhen Jinpai Medical Packaging and Sterilization Service Co., Ltd
Shenzhen Jinnan Medical Testing Technology Co., Ltd
Dongguan Security Medical Packaging Technology Co., Ltd
2、 Time and location
Training time: March 23-25, 2022 (9:00-17:00)
Training location: 2nd floor, Building 4, Guanlan Jinxiu Science Park, Longhua District, Shenzhen
3、 Accommodation arrangements
Meal: Chinese food is arranged uniformly, and breakfast and dinner are arranged by the students themselves;
Accommodation: You can help book a nearby hotel (single king room 168 yuan/day; luxury twin room 188 yuan/day).
4、 Training Features
1. Combining theory with practical operation, learning basic knowledge in theory, while conducting standardized practical exercises and guidance;
2. Group teaching: Lecturer demonstration, students hands-on operation, standardized operation techniques;
3. Reduce the training cost of enterprise testing personnel and provide a good growth environment for employees;
4. Through systematic professional learning, improve the technical level of testing personnel and reduce enterprise risks.
5、 Training methods
Adopting a combination of theory and experimental operation mode: providing training materials and experimental samples on-site, and students personally carrying out relevant inspection operations; Lecturers demonstrate the operation, students conduct group experiments, and guide and standardize the operation process and techniques of students.
6、 Training benefits
1. Master the preparation, use, and acceptance management methods of microbial testing room culture media;
2. Master the preparation method of<100cfu bacterial suspension;
3. Master the applicability inspection method of microbial counting culture medium method;
4. Master the applicability testing methods of sterile examination culture medium methods;
5. Mastering product bioburden testing in accordance with ISO11737.1-2018 and GB/T19973.1-2015 (including applicability testing of bioburden methods, product correction coefficients, and bioburden testing);
6. Master the methods for conducting product sterility tests in accordance with ISO11737.2-2019, GB/T19973.2-2018, Chinese Pharmacopoeia, American Pharmacopoeia, and European Pharmacopoeia.

7、 Lecturer
Teacher Zhang Lan
Master of Microbiology
Engaged in inspection and laboratory management related to medical devices for many years;
Proficient in microbial testing, chemical testing, and cleanroom testing related to sterile medical devices;
Proficient in all international and domestic standards related to testing, such as GB, ISO, CP, USP, EP, etc;
Proficient in quality control and evaluation criteria for sterile medical devices;
Currently serving as the Laboratory Manager and CNAS, CMA Microbiology, Chemistry, Packaging of Shenzhen Jinnan Medical Testing Technology Co., Ltd
Authorized signatories in all testing fields.
Teacher Jiang Guize
Master's degree in Microbiology
Since graduation, I have been engaged in medical device and drug related testing;
Familiar with microbiological and chemical testing related to medical devices and drugs;
I am currently serving as the supervisor of the microbiological and chemical testing room of Shenzhen Jinnan Medical Testing Technology Co., Ltd. and the authorized signatory in the fields of CNAS and CMA microbiological and chemical testing.
8、 Trainees
Microbial inspector for medical device enterprises. According to the "Guidelines for Onsite Inspection of Medical Device Production Quality Management Standards", each enterprise should have corresponding full-time inspection personnel.
9、 Training fees and account information
1. Training fee: 3680 yuan/person (including training fee of 2000 yuan, material fee, and venue fee of 1680 yuan). Please confirm that the trainees will complete the payment before March 10th. The training fee can be transferred to the company's bank account. You can contact Miss Huang, customer service, before making the payment.
2. Training discount: Customers who register within February 2022 will enjoy a 25% discount on training fees. The limit for theoretical and practical classes is 40 people, and those exceeding the limit will be transferred to the next phase.
3. Transfer account:

Account Name: Shenzhen Jinnan Medical Testing Technology Co., Ltd
Account 775774237337
Opening Bank: Bank of China Limited Shenzhen Minzhi Branch

Note: Please indicate the company name for remittance
10、 Contact information
1. Training contact person: Miss Huang
2. Registration phone number: 0755-29362289/191 2949 0661 (same WeChat account, please note: enterprise+name+training name when adding WeChat)
3. Registration email: ks09@kingservice-ps.com
4. Registration method: Fill in the registration receipt in detail, send an email to the above contact person, or scan the QR code "Forecast Name" to register.

Attachment 1: Training Schedule

Attachment 2: Registration Receipt Form