Training notice for the three-day microbiological inspection specification for medical devices

March 23-25, 2022

All relevant units:

　　The quality of terminally sterilized medical devices is related to the health and safety of patients and patients. Medical device quality inspectors play a key role in product quality control. How can medical device companies 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 microbial control level and product testing ability of medical device enterprises in the production process, guide microbial inspectors to establish product bioburden and sterility test operating procedures, standardize operating methods, and comprehensively improve the theoretical knowledge and hands-on ability of inspectors , specially hold this training course. At the end of the training, a medical device microbiological inspector training certificate will be issued . Relevant matters are notified as follows:

1. Organization

Shenzhen Jinpai Medical Packaging Sterilization Service Co., Ltd.

Shenzhen Jinnan Medical Testing Technology Co., Ltd.

Dongguan Anbao Medical Packaging Technology Co., Ltd.

2. Time and place

Training time: March 23-25, 2022 ( 9:00-17:00)

Training location: 2nd Floor, Building 4, Fairview Science Park, Guanlan, Longhua District, Shenzhen

3. Accommodation arrangements

Meals: Chinese meals are arranged uniformly, and breakfast and dinner are arranged by students themselves;

Accommodation: Can help to book nearby hotels (168 yuan/day for single double bed room; 188 yuan/day for deluxe twin bed room).

4. Training Features

1. Combining theory with practice, learn basic knowledge in theory, and conduct standardized practical exercises and guidance at the same time;

2. Group teaching: Lecturer demonstration, students hands-on operation, standardized operation techniques;

3. Reduce the training cost of enterprise testing personnel and provide employees with a good growth environment;

4. Through systematic professional learning, improve the technical level of testing personnel and reduce enterprise risks.

5. Training methods

　　The combination of theory and experimental operation is adopted: training materials and test samples are provided on site, and the trainees carry out relevant inspection operations by themselves; the lecturer demonstrates the operation, and the trainees conduct experiments in groups to guide and standardize the trainee's operation process and techniques.

6. Training benefits

1. Master the management methods of the preparation, use and acceptance of the culture medium in the microbiological testing room;

2. Master the preparation method of <100cfu bacterial suspension;

3. Master the applicability inspection method of microbial counting medium method;

4. Master the applicability inspection method of sterility inspection medium method;

5. Master the product bioburden test in accordance with ISO11737.1-2018, GB/T19973.1-2015 (including bioburden method applicability test, product correction factor, bioburden test);

6. Master the method of product sterility test in accordance with ISO11737.2-2019, GB/T19973.2-2018, Chinese Pharmacopoeia, US Pharmacopoeia, and European Pharmacopoeia.

7. Lecturer

Teacher Zhang Lan

　　Master of Microbiology

　　Engaged in medical device related testing and laboratory management for many years;

　　Proficient in microbial testing, chemical testing and clean room 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 the quality control and evaluation criteria of sterile medical devices;

　　Currently serving as the laboratory manager of Shenzhen Jinnan Medical Testing Technology Co., Ltd. and CNAS, CMA Microbiology, Chemistry, Packaging

　　Authorized signatories in all testing fields.

Teacher Jiang Guize

　　Master's Degree in Microbiology

　　Since graduation, he has been engaged in medical device and drug related testing;

　　Familiar with microbiological and chemical tests related to medical devices and drugs;

　　Currently serving as the supervisor of the microbiological and chemical testing department of Shenzhen Jinnan Medical Testing Technology Co., Ltd. and the authorized signatory of CNAS, CMA microbiological and chemical testing.

8. Training Objects

　　Microbiological inspector of medical device enterprises. According to the "Guiding Principles for On-site 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 per person (including training fee 2000 yuan, material fee and site fee 1680 yuan), please confirm that the trainees will complete the payment before March 10. The training fee can be transferred to the company bank account. You can contact customer service Ms. Huang .

2. Training discount: Customers who register within February 2022 will enjoy a 5% discount on training fees . The theoretical and practical class is limited to 40 people, and if the number exceeds the number, it will be transferred to the next session.

3. Transfer account:

Note: Please indicate the company name in the remittance

10. Contact information

1. Training contact person: Ms. Huang

2、报名电话：0755-29362289 / 191 2949 0661(微信同号，添加微信时请备注：企业+姓名+培训名称)

3、报名邮箱：ks09@kingservice-ps.com

4、报名方式：详细填写报名回执，发邮件给以上联系人，或者扫描二维码“预报名”报名。

附件 1：培训日程安排表

附件 2：报名回执表

深圳市金南医疗检测技术有限公司

2022 年 2 月 10 日

附件 1：培训日程安排表

附件2：报名回执表

医疗器械微生物检验员规范化实验实操培训班

2022年3月23日 - 25日

报名回执表