| 2015年6月22日 / Monday, 22 June 2015
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| 数据可靠性保障原则&背景信息 / Data Integrity Assurance Principles & Background Information
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| 08:30-08:45
| 简介 / Introductions
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| 08:45-10:00
| 数据可靠性的当前监管要求 / Current Regulatory Expectations for Data Integrity
- 什么是数据可靠性？如何保证？为什么受到日益关注？ / Data Integrity—What is it? What assures it? Why is this a growing concern?
- 纸质和电子记录的良好文档管理规范 / Good Documentation Practices for Paper and Electronic Records
- 数据生命周期概念 / Data Life Cycle Concepts
- 监管新动态：FDA Part 11 附加检查和2010年至今的监管新动态 / Regulatory Update: FDA Part 11 ‘Add-On’ Inspections and More 2010-present
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| 10:00-10:15
| 茶歇 / Refreshment Break
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| 10:15-12:00
| 理解模式转变 / Understanding the Paradigm Shift:
- 数据可靠性管理治理方案 / Management Governance Programs for Data Integrity
- GxP对数据可靠性的规定和要求 / GxP Regulations and Requirements for Data Integrity
- 21 CFR Part 11 概述 / 21 CFR Part 11 Overview
- 计算机系统验证概述 / Computer Systems Validation Overview
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| 12:00-1:00
| 午餐 / Lunch
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| 1:00-3:00
| 模式转变与启示 / Paradigm Shift and Implications:
- 21 CFR Part 11哪里出错？ / What Went Wrong with 21 CFR Part 11?
- 基于风险的Part 11合规方法 / Risk-based Approach to Part 11 Compliance
- 有关数据可靠性问题的执法案例 – 美国FDA 483s和警告信，欧盟不符合性报告 / Examples of enforcement related to Data Integrity Concerns—U.S. FDA 483s and Warning Letters and EU Non-Compliance Reports
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| 3:00-3:15
| 茶歇 / Refreshment Break
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| 3:15-5:00
| 启示（续） / Implications (continued)
- FDA 483s和警告信与数据可靠性问题相关的缺陷项回复 / Responding to FDA 483s and Warning Letter observations related to Data Integrity Concerns
- 讨论 / Discussions
- 问答 / Q&A
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| 2015年6月23日 / Tuesday, 23 June 2015
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| FDA检查准备 / Preparing for FDA Regulatory Inspections
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| 08:30-9:45
| 用于保证数据可靠性的计算机系统验证 / Computer Systems Validation to Ensure Data Integrity:
- 基于风险的验证方法 / Risk-based Approach to Validation
- “预期用途”验证以及如何确保数据可靠性 / Validation for “Intended Use” and how this assures Data Integrity
- 案例研究 / Case Studies
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| 10:00-10:15
| 茶歇 / Refreshment Break
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| 10:15-12:00
| 电子数据和数据回顾 / Electronic Data & Data Review
- 什么是“原始数据”？ / What is “Raw Data”?
- 什么是“元数据”？ / What is “Metadata”?
- 什么是审计追踪？何时做？频率？ / What Audit Trails? When? How Often?
- 明辨式思维技能用于评估数据有效性 / Critical Thinking Skills to Evaluate Data Validity
- 数据生命周期地图 / Data Life Cycle Maps
- 案例研究 / Case Studies
- 发现数据可靠性问题实操推演 / “Hands-on” Inspection of Live System to Detect Data Integrity Issues
- 业务流程风险评估和风险降低 / Business Process Risk Assessment and Mitigation
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| 12:00-1:00
| 午餐 / Lunch
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| 1:00-2:45
| 电子数据和计算机合规现场检查 / Facility Inspections for Electronic Data & Computer Compliance:
- 质量风险管理：预防和监测数据可靠性控制风险 / Quality Risk Management: Preventing and Detecting Risks in Data Integrity Controls
- 审计风险评估工具 / Audit Risk Assessment Tool
- 关键性评估和方法 / Criticality Assessments and Approaches
- 鉴证审计 — 关键问题和技巧 / Forensic Auditing—Key Concerns and Techniques
- 促进数据可靠性的管理文化 / Management Culture to Foster Data Integrity
- 案例研究 / Case Studies
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| 2:45-3:00
| 茶歇 / Refreshment Break
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| 3:00-4:00
| Peter Baker：美国FDA对数据可靠性的观点 / Peter Baker: U.S. FDA Perspectives on Data Integrity
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| 4:00-5:00
| 研讨会总结 / Workshop Conclusion
- 问答环节 / Question & Answer Session
- 培训证书 / Training Certificates
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| 主持人及演讲人 / Chairs and Speakers
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| Monica Cahilly女士 / Ms. Monica Cahilly
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| Monica Cahilly女士是美国Green Mountain质量保障公司负责人，她自2009年就“发现GxP数据异常并处理”专题培训FDA后，一直负责FDA检查员在相关领域的培训，也是制定中的FDA和WHO数据可靠性指南的专家。她在保证数据可靠性、电脑系统验证和Part 11合规、信息技术/信息服务质量及合规、生物分析/毒理学实验室合规、全面质量系统等领域有20余年的咨询经验。Cahilly女士曾获得Darthmouth学院生物化学学士及MIT遗传毒理学硕士学位。
Monica Cahilly, M.S., President, Green Mountain Quality Assurance, LLC. She was invited to train FDA on the topic of “Detecting Aberrant GxP Data and Handling” in 2009 and has been conducting training of FDA investigators since May 2010. She currently serve as one of the experts panel which are developing guidance of data integrity for FDA and WHO. She has 22+ years consulting experience with specialized interest in (and enthusiasm for) Data Integrity Assurance, Computer Systems Validation (CSV) and 21CFR Part 11 compliance, Information Technology/Information Services Quality & Compliance, Bioanalytical/ Toxicology Laboratory Compliance, and general Quality Systems. Monica holds a B.A. Biochemistry from Dartmouth College, a M.S. Genetic Toxicology from MIT.
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| Peter Baker 先生 / Mr. Peter Baker
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| Peter Baker先生现任美国FDA中国办公室检查官、数据可靠性专家。Peter于旧金山州立大学获得分析化学硕士学位，曾在制药行业内工作。在加入中国办公室之前，有两年半的时间在FDA印度办公室担任检查官。自2008年起，Peter便代表FDA在世界各地执行药品检查工作。
Peter Baker, an investigator and data integrity specialist for FDA China Office in Beijing. He received his Master’s degree in Analytical Chemistry from San Francisco State University and has previous experience working in pharmaceutical manufacturing. Prior to joining FDA’s China Office, he spent two and a half years working in the FDA India Office based in New Delhi. He has been performing pharmaceutical inspection on behalf of the FDA around the world since 2008.
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| 王刚 博士 / Dr. Gang Wang
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| 王刚博士现任美国FDA中国办公室助理主任。主要负责药品与生物制品相关的政策分析、能力建设和合作项目。曾任FDA/CBER/OCBQ/DMPQ的高级审评员，主要负责审查及评估各种生物药品申请/提交及补充的CMC和CGMP相关问题，并进行许可前检查(PLI)和批准前检查(PAI)。他于1995年获得美国Dartmouth医学院博士学位，曾在美国NIH旗下的NCI从事博士后研究。北京大学国际药物工程管理（IPEM）硕士项目教学指导委员会委员、论文指导教师、授课教师。
Dr. Gang Wang is Assistant Country Director for FDA China Office in Beijing, responsible for policy analysis, capacity building and collaborative programs of drugs and biologics. He was a senior reviewer, lead inspector and an expert biologist with FDA/CBER/OCBQ/DMPQ for CMC and CGMP issues of applications and inspections. He received his Ph.D. in pharmacology and toxicology from Dartmouth Medical School. He conducted his postdoctoral training in cancer immunotherapy at the National Cancer Institute (NCI), National Institutes of Health (NIH). Dr. Wang is the teaching faculty and thesis adviser of Peking University IPEM Master's Degree Program.
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