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所在平台: Udemy |
课程主页: https://www.udemy.com/course/computerised-system-validation-csv-readyness/
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课程名称：根据GAMP5指南进行计算机化系统验证 (CSV) 课程概述：许多人认为计算机化系统验证仅仅是准备IQ、OQ和PQ，这种看法是片面的。本课程将探讨完整计算机化系统验证的要求，帮助学习者全面了解验证过程。课程共分为六个部分，共有七节讲座，欢迎在评论区提问，我将为您解答。 第一部分：计算机系统常见错误。本节将帮助您理解许多专业人士在验证过程中容易犯的错误。 第二部分：cGXP对计算机系统的评估。许多验证方法中缺乏这一评估，首先要评估计算机系统是否具有cGXP影响，然后决定进一步的验证研究及深度。本节内容包括：主题重要性、培训师简介、cGXP评估在制药行业的角色、监管期望、FDA引用、cGXP评估的11个关键要素、常见错误、会议要点和问答环节。 第三部分：对cGXP计算机系统供应商的评价。许多制药企业只评估用于药物生产的原材料供应商，但cGXP计算机系统的供应商也应被评估。本节包括：指南要求（EU、FDA、GAMP）、供应商评估过程、基于风险的决策、邮寄评估注意事项、现场审计评估及良好实践问答环节。 第四部分：验证主计划（VMP）及cGXP计算机系统的质量风险管理。本节将重点讲解如何根据指南准备VMP以及如何执行QRM。内容包括：指南要求、FDA验证指导、VMP的七个关键要素、VMP要素详细讨论、常见错误和问答环节。质量风险管理的讲座将涵盖：CSV的目的和范围、计算机系统的QRM指南要求、质量风险管理概述、风险评估的实用方法以及验证生命周期内的风险管理。 第五部分：组织如何准备接受检查的相关信息。 第六部分：业务连续性和灾难恢复计划的重要性。如果没有这一计划，计算机化系统验证将失去意义。这些都是计算机化系统验证的先决条件。
Many people think that the computerized system validation is nothing but just preparation of IQ, OQ, and PQ. But this is just an incomplete way of computerized system validation. So, we have made some sections in this guide that will discuss their requirements and also make the learner or participant aware of how to do complete validation.This course contains a total of 6 sections and 7 lectures. If you have any question/s, you can put your question/s in the comments section. I will clarify your questions.The first section includes information about Common errors related to computerized systems. This short recording will help you understand how many professionals make errors.The second section includes information about the cGXP Assessment of the computerized systems. This is missing in most of the computerized systems validation approaches. First, the computerized systems should be evaluated whether it is having a cGXP impact or not. Based on that further validation study and depth of validation should be decided. The training session includes below points;Importance of topicKnow your TrainerRole of cGXP Assessment in PharmaceuticalsRegulatory ExpectationsFDA Citations11 Keys for cGXP AssessmentCommon ErrorsTake Away from the sessionQ & AThe third section includes information about Vendor evaluation of cGXP computerized systems. Many pharmaceuticals only evaluate the vendors for input materials used for manufacturing the drugs and drug products. But, the cGXP computerized systems vendors also should be evaluated. This session includes;Guideline Requirements - EU, FDA, GAMPVendor Evaluation ProcessRisk-based Decision MakingPostal Assessment - Points to consider, when postal assessment is suitable, key points to consider during postal assessment.Onsite Audit Assessment - Supplier Good PracticesQ & AThe fourth section includes information about the validation master plan (VMP) and also Quality Risk Management of cGXP computerized systems. This section will focus on how to prepare VMP in line with the guidelines and how to perform the QRM.The VMP lecture includes;Guideline Requirements - EU, FDAValidation Guidance by FDA7 Key Elements of VMPVMP elements discussion in detailCommon ErrorsQ & AThe lecture on Quality Risk Management includes below points;Purpose and Scope of CSVQRM - Guideline Requirements in Computerised SystemsQuality Risk Management - OverviewQuality Risk Management - Practical ApproachRisk Management to Evaluate Potential ImpactRisk Management within the Validation LifecycleQ & AThe fifth section includes information explaining how the organization should be ready for inspections.The last section which is section six explains the business continuity and disaster recovery plan. Without this plan, the computerized system validation will not have any meaning.These all are the prerequisites for computerized system validation.
