organizer

Pharmaceutical and Chemical Industry Committee of China Chemical Enterprise Management Association

Pharmaceutical Materials Information Technology (Beijing) Co., Ltd.

all relevant units

The Quality Assurance Department (QAU) is mainly responsible for GLP compliance supervision within GLP institutions. Its purpose is to promptly discover problems existing in various departments or project implementation, discover them as soon as possible, and correct them as soon as possible to avoid the expansion of defects. QAU is a GLP laboratory. A specially established and relatively independent third party within the laboratory. Its work focuses on objectively and truly supervising and inspecting the standardization of experimental facilities, special experimental research, experimental operations, etc. In special research verification, QAU must not only adhere to principles, but also grasp the scale and be flexible to reduce errors in research implementation, ensure the quality of safety evaluation, and thereby ensure the authenticity and reliability of research results.

In order to solve technical problems in the actual work of QA personnel and improve the professional level of QA personnel, the Pharmaceutical and Chemical Professional Committee of the China Chemical Enterprise Management Association plans to hold the "2024 Drug Non-Clinical Safety Evaluation Quality Assurance" online from April 27 to 28, 2024 "Special Training Course" invites authoritative experts in the industry to conduct in-depth analysis of relevant issues, and invites all units to actively select personnel to participate.

meeting arrangements

meeting place:Tencent Meeting (notify the specific address to registered personnel)

meeting time:April 27 - 28, 2024

training syllabus

Day 1 09:00-12:00 13:30-16:30

April 27 9:00-12:00 Teacher Li Hong

1. Requirements of regulatory guidelines for QAU departments of GLP laboratories

1. Definition of QA in OECD/FDA/34

2. Inspection points and determination principles for the certification of Good Laboratory Practice for Non-Clinical Pharmaceutical Research

2. Responsibilities of the QAU

1. Responsibilities of QAU in the GLP specifications issued by the State Food and Drug Administration

2. Differences in QAU responsibilities in GLP regulations between China and the United States and the United States and what the United States can learn from for China

3. QA's audit priorities and regulatory requirements for computerized systems

April 27 13:30-16:30 Teacher Wang Yong

4. Management and quality assurance of GLP laboratory standard operating procedures

1. SOP management

1.1 Formulation of SOP

1.2, SOP release, distribution and training

1.3, SOP Waste Recycling, Destruction

1.4, SOP revision

1.5, form management

2. QAU's quality assurance for SOP management

2.1 Quality assurance of the formulation/revision process

2.2 Quality assurance for SOP implementation

2.3 Quality assurance for preservation of, SOP and record documents

3. The role of QAU in the formulation, management and implementation of SOPs

5. Quality management of QA documents, archives, and experimental data

1. Management of QA documents

2. Archives management

3. Quality management of experimental data

The next day 09:00-12:00 13:30-16:30

April 28 9:00-12:00 Teacher Qiao Hongqun

6. QAU inspection process, inspection types, inspection requirements and quality control points

1. Research-based on-site inspections

2. Process-based on-site inspection

3. Facilities based on-site inspections

3. On-site inspection based on multi-site research

4. Inspection of QAU by management agencies

7. Common questions about QA verification of GLP laboratory special research

1. Special research verification content

2. Common problems found during the verification process

3. Causes and solutions to common problems found during special research and verification

April 28 13:30-14:30 Teacher Li Min

8. Application of risk management and establishment and implementation of risk-based quality assurance plans

April 28 14:30-15:30 new teachers

9. Application of quality tools (6 Sigma) in quality management

April 28 15:30-16:30

10. The impact of artificial intelligence (AI)/big data on QA

Introduction to the lecturer

1. Teacher Li Hong, 国科赛赋河北医药技术有限公司副总经理、质量保证部负责人。中国毒理学会毒理研究质量保证专业委员会。从事药物安全性评价质量工作十余年，承担安评研究质量工作百余项，在细胞和基因类药物、抗体药物、化学药物及中药的药代动力学、药物安全性评价等研究领域具有丰富的质量保证经验。曾主导并接受FDA、OECD GLP现场核查，建立了符合国内外标准的GLP质量体系。曾先后负责本公司GLP认证工作并一次性取得国家药监局GLP 9项GLP资质；、OECD GLP认证工作并零缺陷通过OECD GLP认证。

2. Teacher Wang Yong, 益诺思生物技术南通有限公司质量保证部副总监，硕士，副高级研究员；具有10年+QAU工作经验，并通过美国SQA协会注册QA考试获得RQAP- GLP资质；中国毒理学会会员；江苏省科技咨询专家库专家；参与3所GLP试验机构的国内外GLP体系建立、运行并通过认证，拥有丰富的GLP实践经验。

3. Professor Qiao Hongqun, 主任药师，江苏省药物安全性评价中心副主任、QAM，中国毒理学会毒理研究质量保证专业委员会委员，江苏省药品审评专家库专家，江苏省科技厅专家，广东省科技厅专家，山东省科技厅专家。研究方向：药物毒理学，药物安全性评价，药物代谢毒理学，药物分析。主要从事新药的安全性评价工作，毒代动力学研究。近年来主持完成江苏省产学研合作项目1项，参与在研两项。发表核心期刊以上论文30余篇。

4. Teacher Li Min，医学博士，副研究员，具有近十五年GLP QAU质量保证工作经验。主要负责机构GLP/GCLP质量体系建设、对接监管机构（中国、FAD、OECD）和委托方检查、文档管理、供应商稽查等事宜，此外还从事研究方向为药物心脏毒理学及药物致癌性等研究。

5. Teacher Zhang 质量与合规深资专家，注册质量工程师，六西格玛黑带。从事制药行业质量管理和合规运营近三十年，曾在国内多家知名药企业担任质量受权人和质量运营高管。

Participants

Pharmaceutical company/CRO laboratory R & D, registration application, QAU department personnel, QC personnel, and corporate executives. Relevant personnel from other institutions.

meeting notes

1. Theoretical explanation, case analysis, special lectures, interactive Q & A

2. The keynote speakers are all senior experts in the industry. Welcome to inquire.

3. Enterprises need internal training and guidance, please contact the conference team

training costs

conference fee:4000 yuan/account meeting fee includes:Training, Q & A, electronic materials, video playback, etc.)

remittance account

Please comment on the payment: GLP-QAU

unit name:Pharmaceutical Materials Information Technology (Beijing) Co., Ltd.

Company account number:0200316909100078392

opening bank:Industrial and Commercial Bank of China Co., Ltd. Fangshan Branch Liangxiang Branch

remarks:The invoice shows that Industrial and Commercial Bank of China Co., Ltd. Beijing California Shuijun Branch

Registration method

扫描下方二维码或者点击“read the original”，登记信息后，会务人员将与您沟通培训相关细节。

This meeting is limited to 100 companies. Welcome发送公司名称+姓名+电话预登记。Sign up by SMS, WeChat, and email.

contact:Lu Yao 13910496728 (WeChat synchronization)

Scan the QR code and sign up

Click to read the original registration information

* The above content contains advertisements