2024年9月9-11日，FDA和美国注射剂协会 (PDA) 将在华盛顿特区举办第33届联合监管会议（Joint Regulatory Conference），重点讨论有效的质量体系在确保整个产品生命周期持续受控状态方面的作用。会议旨在分享作为 CGMP 合规基础的系统性和预防性方法，并确保对生产和供应链风险进行有效的持续管理。
On September 9-11, 2024, U.S. FDA and Parenteral Drug Association (PDA) will host the 33rd Joint Regulatory Conference in Washington DC to emphasize the role of effective quality systems in ensuring an ongoing state of control throughout the product lifecycle. This conference is designed to share systemic and preventive approaches that are foundational to CGMP compliance, and ensure effective ongoing management of manufacturing and supply chain risks.
会议大纲
- 重点讨论稳健的质量体系、企业设施、流程、原材料质量、供应商关系、工业现代化和质量风险管理的重要作用，这些是现行良好生产规范(CGMP)合规性的基础；
- 案例研究，以提供实用见解并说明可持续的合规性如何为质量和供应一致性奠定基础；
- 推动提高质量和造福消费者的国际合作努力。
- focus on the vital role of robust quality systems, facilities, processes, raw material quality, supplier relationships, industrial modernization and quality risk management, which are fundamental to current good manufacturing practice (CGMP) compliance
- include case studies to provide practical insights and illustrate how sustainable compliance establishes the foundation for quality and supply consistency
- highlight international collaboration efforts that improve quality and benefit consumers
会议还将为 FDA 代表和行业专家提供一个开放的讨论论坛，并为当前与生产和质量相关的各种主题提供发表实际见解的机会。例如：
- 建立符合CGMP的质量体系
- 进行强有力的调查
- 避免网络安全和数据可靠性风险
- 确保选择和审核有效的外部供应商
- 使用现有的制造技术来确保CGMP合规性
- 更新CGMP指南
- 老化设施升级
- 有效执行质量保证授权
降低质量控制实验室的风险
- building CGMP-compliant quality systems
- conducting robust investigations
- avoiding cybersecurity and data integrity risks
- assuring effective external supplier selection and auditing
- use of current manufacturing technologies to assure CGMP compliance
- update on latest CGMP guidances
- upgrading aging facilities
- effective implementation of quality assurance authority
- de-risking your quality control laboratory
目标人群
制药公司
监管机构
学术界
质量保证专家
美国和国外的制造业专家和领导者
会议时间
美东时间 2024年9月9-11日 07:15-17:00
北京时间 2023年9月9-12日 19:15-05:00
会议形式
线上直播或华盛顿威斯汀市中心酒店（Westin Washington, DC Downtown）
主讲人
Milind Ganjawala MS, MBA
U.S. FDA | Division Director, DDQ2, OMQ, OC, CDER
自2009年在FDA任职，担任FDA药品质量二部、生产和产品质量办公室、合规办公室、药品评估和研究中心的主任。加入FDA前，曾在世界级制药/生物技术公司拥有超过20年的质量管理职位经验。拥有学士、硕士和工商管理硕士学位。
Mr. Milind Ganjawala serves as the Director of the Division of Drug Quality 2 (DDQ2), Office of Manufacturing and Product Quality (OMPQ), Office of Compliance (OC), Center for Drug Evaluation and Research (CDER), FDA. He began his service with FDA in 2009. Prior to coming to FDA, he had more than 20 years of experience in quality management positions within world-class Pharmaceutical/Biotech companies. He received a BS, M.S. and MBA degrees.
Janeen Skutnik-Wilkinson
Moderna, Inc. | Director, Global Quality, Regulatory Surveillance & External Engagement
Moderna全球质量监管监督主管。曾任Biogen全球监管CMC监管情报总监、质量情报协会总监、NSF DBA副总裁、辉瑞公司质量和监管政策总监/团队负责人。在职期间，负责与行业协会合作、开发企业在质量和CMC方面的职位、监督全球法规/指南/标准。在药典活动、质量和监管政策方面拥有超过28年的经验，并担任过多项职位，如负责文档资料、变更控制、分析方法验证和产品发布等。于1994年获得the University of Connecticut理学学士学位。曾在PDA的RAQAB任职，并担任PDA药典IG的联合主席。ICH Q3D元素杂质工作组的成员。曾担任PhRMA药典联络小组主席(2000-2012)、ICH主题Q4B的PhRMA主题负责人。曾两次担任IPEC组织主席、曾任IPEC联合会主席。IPEC代表，曾出席ICH大会和ICH非正式质量讨论小组。
Ms. Skutnik is the Director of Regulatory Surveillance in Global Quality at Moderna. Her former positions include: Director, Global Regulatory CMC Regulatory Intelligence at Biogen, Association Director, Quality Intelligence at Biogen, Vice President at NSF DBA, Director /Team Leader of Quality & Regulatory Policy at Pfizer. In these roles she was responsible for working with trade associations and developing company positions on Quality and CMC issues, monitoring global regulations/guidelines/standards. She has over 28 years experience in compendial activities, quality and regulatory policy, and has held a variety of positions with responsibilities in documentation, change control, analytical method validation and product launch. Ms. Skutnik earned a Bachelors of Science from the University of Connecticut in 1994. She served on PDA's RAQAB, and is the co-chair of PDA's Pharmacopoeial IG. She is a member of the ICH IWG for ICH Q3D Elemental Impurities, and was on the EWG for Q3D. She was the Chair of PhRMA’s Compendial Liaison Team (2000-2012); and the PhRMA Topic Leader for the ICH Topic – Q4B. She was the chair of the IPEC organisation twice, and was also president of the IPEC Federation. She is the IPEC Delegate to the ICH Assembly and ICH Informal Quality Discussion Group.
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