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CLASS:PUBLIC
DTSTART;TZID=Asia/Kolkata:20200908T150000
DTEND;TZID=Asia/Kolkata:20200911T180000
DTSTAMP:20200625T130900
UID:MEC-1e3b21cb226c39b6aa4634f820b372f3@biiworld.com
CREATED:20200625
LAST-MODIFIED:20200714
PRIORITY:5
TRANSP:OPAQUE
SUMMARY:Computer System Validation (CSV) & Data Integrity Challenges
DESCRIPTION:\nReal Time Online Delivery – Live Training Sessions\nVirtual Attendance for 4 Days Training \nGuided Learning Hours – 16 (4 Hrs x 4 Days)\nCase Studies, Practical Exercises, Q & A, \nPre-Course Access: Intro Session Coupon, Pre-Event Questionnaire, Presentation Slide Deck\n7+ Delegates Registration Group Discount\n\nCourse Overview\nThis 4 Day Online Course will give insights about FDA/EMA/MRHA regulations for pharmaceuticals, medical devices, biologicals, tobacco and tobacco-related products (e-cigarettes, e-liquids/vaping, cigars) that pertain to computer systems used to create/collect, analyze, manage, report and transfer data (structured) and documents (unstructured) that support regulatory compliance.  Learn about FDA’s efforts with EMA and MRHA to move to a more consistent framework & procedures for evaluating computer systems, based on risk, and ensuring data/document integrity is maintained throughout their life cycle.  The Mutual Recognition Agreement (MRA) between FDA and EMA will be discussed.\nReview key components and deliverables of the Computer System Validation (CSV), based on the System Development Life Cycle (SDLC) Methodology.  You will also learn about a validation strategy for mobile applications & systems that are cloud-based and 21 CFR Part 11, FDA’s guidance for electronic records and signatures, and the importance of data integrity to compliance activities.  Examples of FDA actions and citations will be provided and best practices to meet compliance requirements and ensure a company is inspection ready.\nAs regulated products are often subject to counterfeit activity, you will learn about the efforts by US agencies, including FDA and Customs and Border Protection, to improve global supply chain security.  Understand how the Customs and Trade Partnership Against Terrorism (C-TPAT), a voluntary program, provides a framework based on minimum security requirements that provide great benefit to member  companies in terms of the speed and ease of moving products through the global supply chain.\nImportance of performing a vendor audit for suppliers of computer systems, components and services will be discussed.  In addition, you will learn about the challenges and best practices associated with compliance for software used with medical devices and Software as Medical Device (SaaS) products.\nTrainer’s Profile\nOur Expert Trainer is a Consultant & Training Specialist with 40+ years of experience in the pharmaceutical, medical device, biological, tobacco-related (e-cigarettes, e-liquids, cigars) and other FDA-regulated industries. \nOur Expert worked directly and on consulting basis for many of the large regulated companies in the USA & Europe, developing and executing compliance strategies & programs for Computer System Validation (CSV) and Data Integrity. \nOur Expert participated in the FDA/Industry partnership that resulted in issuing 21 CFR Part 11, FDA’s guidance for electronic records/signature.\nOur Expert continues to speak and provide training worldwide about FDA and global agency trends in compliance, inspection and enforcement. \nKey Takeaways\n\nDiscuss how to meet current FDA regulations, including cGxPs and 21 CFR Part 11 for electronic records and signatures\nUnderstand how the Medicine and Healthcare Regulatory Agency (MRHA) in the UK plays a role in determining regulatory compliance within the EU\nBecome proficient in how to validate a computer system that houses regulated data and documentation through a deep dive into the Computer System Validation (CSV) approach, which is based on the System Development Life Cycle (SDLC) methodology\nCreate and maintain data and documents with integrity through their entire life cycle; data integrity issues have been a very strong focus of recent FDA inspections and audits \nEvaluate how to fit the CSV process and maintenance of data/document integrity into the Quality Management System to achieve results that will benefit the company’s bottom line and reputation\nFocus on how FDA expects industry to develop a risk-based approach to validation of a FDA- regulated computer system, along with considering the size, complexity, business criticality and GAMP 5 category of the system\nLearn about industry deficiencies and best practices to better align CSV and data/document integrity activities with key areas of focus\n\nWho Should Attend\n\nInformation Technology (IT) Analysts\nIT Developers & Support Staff\nQC/QA Managers & Analysts\nClinical Data Managers & Scientists\nCompliance Managers & Auditors\nLab Managers & Analysts\nComputer Systems Validation Specialists \nGMP Training Specialists \nBusiness Stakeholders using Computer Systems regulated by FDA\nRegulatory Affairs Personnel\nConsultants in Life Sciences & Tobacco Industries \nComputer System Vendors & Service Providers (Implementation, Hosting, Configuration, Customization)\nSoftware Vendors providing Medical Device Software & Software as a Medical Device(SaaMD)\nProfessional from tobacco-related product (e-cigarettes, e-liquids/vaping, cigars) industries\n\n \n\nFor participation details contact\nSamuel Isaac\nsamuel.isaac@biiworld.com ( mailto:samuel.isaac@biiworld.com )\n+1 786 633 1223(Canada)\nFill the details below to request your Brochure\n\n \n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n×\n
URL:https://biiworld.com/trainings/computer-system-validation-csv-data-integrity-challenges/
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