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DTSTART;TZID=America/Chicago:20250828T110000
DTEND;TZID=America/Chicago:20250828T123000
DTSTAMP:20260405T060006
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UID:10000265-1756378800-1756384200@validationcenter.com
SUMMARY:Best-in-Class Documentation for CSV Program - August 2025
DESCRIPTION:Free Webinar \nComputer Systems Validation (CSV) is required by the FDA and many other international regulatory agencies. However\, it is often unclear what steps to take to implement a successful Computer Systems Validation Program.\nIn this 1-hour free webinar\, you will learn: \n\nHow to establish and structure an effective CSV Program?\nWhich high-quality documents need to be created and maintained for a successful CSV Program?\nWhat are the required Standard Operating Procedures (SOPs) and how to create them?\nWhat content should be included in which CSV document?\nWhat makes CSV deliverables\, SOPs\, and templates “best-in-class”?\nWhat auditors are looking for a successful CSV Program?\n\nYou will discover common mistakes and how you can avoid them. This webinar also provides you with a walk-through process of Computer System Validation key deliverables. \nComputer System Validation Webinar Topics\n\nWhat are the steps you need to take to implement a Computer System Validation program?\nWhat is the best structure for CSV Program Documents and Tools?\nWhat is Global Policy? What are the examples?\nWhat is Validation Master Plan? How to create it?\nWhat is an SOP? What are the SOPs required for CSV and how to create them?\nWhat is Work Instruction (WI)?\nWhat are the CSV templates you should develop? What content should be included?\nWhy should you have a successful CSV Program?\n\nCost: FREE
URL:https://validationcenter.com/courses/best-in-class-documentation-for-csv-program-august-2025/
LOCATION:Online
CATEGORIES:Best-in-Class Documentation for CSV Program Classes
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Chicago:20250826T140000
DTEND;TZID=America/Chicago:20250826T153000
DTSTAMP:20260405T060006
CREATED:20241106T211517Z
LAST-MODIFIED:20241106T211518Z
UID:10000159-1756216800-1756222200@validationcenter.com
SUMMARY:Cloud and SaaS in GxP Webinar - August 2025
DESCRIPTION:Learn How Regulations Impact Your Cloud and SaaS Implementation\nIn this free webinar\, you will learn the basics of Cloud terminology and implementation models.  And\, we will show you how regulations such as 21 CFR 11\, 21 CFR 820\, and Annex 11 can impact the model you choose. \nDuration: 1.5 hours \nClick here to read the full description  \nFor best results\, use a Chrome browser when registering.
URL:https://validationcenter.com/courses/cloud-and-saas-in-gxp-webinar-august-2025/
LOCATION:Online
CATEGORIES:Cloud and SaaS Validation
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Chicago:20250821T110000
DTEND;TZID=America/Chicago:20250821T123000
DTSTAMP:20260405T060006
CREATED:20241106T211509Z
LAST-MODIFIED:20241106T211509Z
UID:10000158-1755774000-1755779400@validationcenter.com
SUMMARY:Risk-Based Approach to Software Quality & Validation Webinar - August 2025
DESCRIPTION:Learn a Risk-Based Approach for Your Next CSV Project\nFree webinar on risk management topics including terminology\, FDA guidance\, practical method of risk assessment\, approaches for risk-based computer system validation\, and examples of FDA Warning Letters regarding risk management. \nDuration: 1.5 Hours \nClick here to read the full description \nFor best results\, use a Chrome browser when registering.
URL:https://validationcenter.com/courses/risk-based-approach-to-software-quality-validation-webinar-august-2025/
LOCATION:Online
CATEGORIES:Risk Based Approach
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Chicago:20250811T103000
DTEND;TZID=America/Chicago:20250813T160000
DTSTAMP:20260405T060006
CREATED:20241106T141452Z
LAST-MODIFIED:20241106T141452Z
UID:10000222-1754908200-1755100800@validationcenter.com
SUMMARY:Computer System Validation (CSV) for Cloud/COTS - USA - August 2025
DESCRIPTION:Navigating CSV in COTS Environments: A Comprehensive Guide\nThis class has been designed to help you understand CSV Methodologies Tailored for Commercial Off-The-Shelf (COTS) Applications. We’ll share more about the nuances of implementing CSV specifically for COTS applications\, providing a roadmap for compliance and smooth integration in diverse software environments. \nTime: 10:30 AM – 4:00 PM US Central Time each day (8:30-2:00 PM PT / 11:30-5:00 PM ET) Not your time zone? Try this converter tool. \nRead more about this course
URL:https://validationcenter.com/courses/computer-system-validation-csv-for-cloud-cots-usa-august-2025/
LOCATION:Online
CATEGORIES:CSV for Cloud and COTS Applications
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Amsterdam:20250806T100000
DTEND;TZID=Europe/Amsterdam:20250806T113000
DTSTAMP:20260405T060006
CREATED:20241106T141625Z
LAST-MODIFIED:20241106T141625Z
UID:10000241-1754474400-1754479800@validationcenter.com
SUMMARY:Computer System Validation (CSV) Basics Webinar - EU - August 2025
DESCRIPTION:Get an Introduction to Computer System Validation\nFree webinar on basic computer system validation (CSV) topics including FDA regulations and guidelines\, which systems require validation\, the CSV process and deliverables\, and steps for implementing a computer system validation program. \nDuration: 1.5 Hours \nRead the full description \nFor best results\, use a Chrome browser when registering.
URL:https://validationcenter.com/courses/computer-system-validation-csv-basics-webinar-eu-august-2025/
LOCATION:Online
CATEGORIES:Computer System Validation Basics
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Chicago:20250805T110000
DTEND;TZID=America/Chicago:20250805T123000
DTSTAMP:20260405T060006
CREATED:20241106T211459Z
LAST-MODIFIED:20241106T211459Z
UID:10000157-1754391600-1754397000@validationcenter.com
SUMMARY:Preparing for a Software Quality Audit Webinar - August 2025
DESCRIPTION:Get Prepared for Your Upcoming Inspection\nFree webinar on audit topics including standard terminology\, preparation of validation documentation\, SOPs\, and personnel\, frequently asked audit questions\, best-practice audit tactics\, and frequent FDA inspection topics for computer systems. \nDuration: 1.5 Hours \nRead more about this webinar \nFor best results\, use a Chrome browser when registering.
URL:https://validationcenter.com/courses/preparing-for-a-software-quality-audit-webinar-august-2025/
LOCATION:Online
CATEGORIES:Software Quality Audit
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Chicago:20250731T140000
DTEND;TZID=America/Chicago:20250731T153000
DTSTAMP:20260405T060006
CREATED:20241106T211441Z
LAST-MODIFIED:20241106T211441Z
UID:10000156-1753970400-1753975800@validationcenter.com
SUMMARY:Annex 11 Intro Webinar - July 2025
DESCRIPTION:Learn How to be Compliant with Annex 11\nIn this free webinar\, you will learn key EU terminology fundamental for understanding Annex 11 as well as the history of Annex 11. We will walk through the detailed requirements of Annex 11 and explore approaches and processes for achieving compliance. You will come to appreciate where the requirements of Annex 11 are similar to Part 11\, and where they differ. And finally\, we will review related EU regulations and guidance\, and explain how Annex 11 is being applied to US companies via PIC/S. \nDuration: 1.5 hours \nRead the full course description \nFor best results\, use a Chrome browser when registering.
URL:https://validationcenter.com/courses/annex-11-intro-webinar-july-2025/
LOCATION:Online
CATEGORIES:Annex 11
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Chicago:20250722T140000
DTEND;TZID=America/Chicago:20250722T153000
DTSTAMP:20260405T060006
CREATED:20241106T211432Z
LAST-MODIFIED:20241106T211432Z
UID:10000155-1753192800-1753198200@validationcenter.com
SUMMARY:Electronic Data Integrity Webinar - July 2025
DESCRIPTION:Prevent or Remediate Electronic Data Integrity Gaps in Your Organization\nFree webinar on the history of data integrity regulations and guidelines\, along with examples of where to look for electronic Data Integrity risks in your organization. \nDuration: 1.5 Hours \nRead the full description \nFor best results\, use a Chrome browser when registering.
URL:https://validationcenter.com/courses/electronic-data-integrity-webinar-july-2025/
LOCATION:Online
CATEGORIES:Electronic Data Integrity
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Chicago:20250714T120000
DTEND;TZID=America/Chicago:20250715T153000
DTSTAMP:20260405T060006
CREATED:20241106T141517Z
LAST-MODIFIED:20241217T191324Z
UID:10000238-1752494400-1752593400@validationcenter.com
SUMMARY:Intro to Computer System Validation (CSV) - USA - July 2025
DESCRIPTION:Learn the Essential Elements to Efficient Validation Protocols and Documentation\nLearn to develop precise and effective validation protocols\, documentation\, and reports\, essential for streamlined and successful system validation processes. \nTime: 12:00 PM – 3:30 PM US Central Time each day. Not your time zone? Try this tool. \nRead more about this class
URL:https://validationcenter.com/courses/intro-to-computer-system-validation-csv-usa-july-2025/
LOCATION:Online
CATEGORIES:Introduction to CSV
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Chicago:20250710T110000
DTEND;TZID=America/Chicago:20250710T123000
DTSTAMP:20260405T060006
CREATED:20241106T212723Z
LAST-MODIFIED:20241106T212723Z
UID:10000258-1752145200-1752150600@validationcenter.com
SUMMARY:Computer Software Assurance (CSA) Principles Webinar - July 2025
DESCRIPTION:Upgrade your CSV Program with Computer Software Assurance: A Practical Approach\nLearn about Computer Software Assurance (CSA) and how it can be used to update your current computer system validation (CSV) program to meet regulatory requirements. The webinar covers the CSA approach for identifying a system’s intended use\, categorizing use\, identifying software failure risks\, and classifying these risks for subsequent assurance activities\, along with providing relatable examples and real-life scenarios. \nDuration: 1.5 hours \nClick here to read the full description \nFor best results\, use a Chrome browser when registering.
URL:https://validationcenter.com/courses/computer-software-assurance-csa-principles-webinar-july-2025/
LOCATION:Online
CATEGORIES:Computer Software Assurance
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Amsterdam:20250630T103000
DTEND;TZID=Europe/Amsterdam:20250702T160000
DTSTAMP:20260405T060006
CREATED:20241106T141516Z
LAST-MODIFIED:20241106T141516Z
UID:10000237-1751279400-1751472000@validationcenter.com
SUMMARY:Computer System Validation (CSV) for Cloud/COTS - EU - June 2025
DESCRIPTION:Learn to Validate for Your Cloud-based\, SaaS\, COTS\, or OOTB Application\nThis class has been designed to ensure that you leave knowing what to validate\, how to validate\, and when to leverage vendor-supplied documentation in your validation. You will also learn the necessity and power of vendor assessments and risk-based validation. \nTime: 10:30 AM – 4:00 PM Central European Time each day (8:30-2:00 PM PT / 11:30-5:00 PM ET) Not your time zone? Try this converter tool. \nRead more about this course
URL:https://validationcenter.com/courses/computer-system-validation-csv-for-cloud-cots-eu-june-2025/
LOCATION:Online
CATEGORIES:CSV for Cloud and COTS Applications
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Chicago:20250624T110000
DTEND;TZID=America/Chicago:20250624T123000
DTSTAMP:20260405T060006
CREATED:20241106T211354Z
LAST-MODIFIED:20241106T211354Z
UID:10000247-1750762800-1750768200@validationcenter.com
SUMMARY:Computer System Validation Basics Webinar - June 2025
DESCRIPTION:Get an Introduction to Computer System Validation\nFree webinar on basic computer system validation (CSV) topics including FDA regulations and guidelines\, which systems require validation\, the CSV process and deliverables\, and steps for implementing a computer system validation program. \nDuration: 1.5 Hours \nRead the full description \nFor best results\, use a Chrome browser when registering.
URL:https://validationcenter.com/courses/computer-system-validation-basics-webinar-june-2025/
LOCATION:Online
CATEGORIES:Computer System Validation Basics
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Chicago:20250619T140000
DTEND;TZID=America/Chicago:20250619T153000
DTSTAMP:20260405T060006
CREATED:20241106T211356Z
LAST-MODIFIED:20241106T211356Z
UID:10000248-1750341600-1750347000@validationcenter.com
SUMMARY:Spreadsheet Validation Webinar - June 2025
DESCRIPTION:Get a Proven\, Streamlined Approach to Spreadsheet Documentation and Validation\nFree webinar on spreadsheet compliance topics including FDA guidance on spreadsheets\, streamlined approach to spreadsheet validation\, 21 CFR Part 11 compliance\, and examples of FDA Warning Letters regarding spreadsheets. \nDuration: 1.5 hours \nClick here to read the full description \nFor best results\, use a Chrome browser when registering.
URL:https://validationcenter.com/courses/spreadsheet-validation-webinar-june-2025/
LOCATION:Online
CATEGORIES:Spreadsheet Validation
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Chicago:20250610T140000
DTEND;TZID=America/Chicago:20250610T153000
DTSTAMP:20260405T060006
CREATED:20241106T211359Z
LAST-MODIFIED:20241106T211359Z
UID:10000249-1749564000-1749569400@validationcenter.com
SUMMARY:Fundamentals of 21 CFR 11 Webinar - June 2025
DESCRIPTION:Get a Step-by-Step Approach for How to Launch Your Own Part 11 Compliance Initiative\nFree webinar on Part 11 topics including 21 CFR Part 11 history\, requirements for electronic records\, electronic signatures\, and open systems\, launching a Part 11 initiative\, and recent FDA Warning Letters for electronic record issues. \nDuration: 1.5 hours \nClick here to read the full description
URL:https://validationcenter.com/courses/fundamentals-of-21-cfr-11-webinar-june-2025/
LOCATION:Online
CATEGORIES:Fundamentals of 21 CFR Part 11
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Amsterdam:20250604T100000
DTEND;TZID=Europe/Amsterdam:20250604T113000
DTSTAMP:20260405T060006
CREATED:20241106T141516Z
LAST-MODIFIED:20241106T141516Z
UID:10000236-1749031200-1749036600@validationcenter.com
SUMMARY:Risk Based Approach to Software Quality & Validation - EU - June 2025
DESCRIPTION:Learn a Risk-Based Approach for Your Next CSV Project\nFree webinar on risk management topics including terminology\, FDA guidance\, practical method of risk assessment\, approaches for risk-based computer system validation\, and examples of FDA Warning Letters regarding risk management. \nDuration: 1.5 Hours \nClick here to read the full description \nFor best results\, use a Chrome browser when registering.
URL:https://validationcenter.com/courses/risk-based-approach-to-software-quality-validation-eu-june-2025/
LOCATION:Online
CATEGORIES:Risk Based Approach
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Chicago:20250527T100000
DTEND;TZID=America/Chicago:20250527T110000
DTSTAMP:20260405T060006
CREATED:20250326T201431Z
LAST-MODIFIED:20250331T200116Z
UID:10000170-1748340000-1748343600@validationcenter.com
SUMMARY:Validating AI for Visual Inspections Webinar - May 2025
DESCRIPTION:Validating AI for Visual Inspections Webinar\nArtificial Intelligence is everywhere. In January 2025 the FDA released – Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products Guidance for Industry and Other Interested Parties. PBL and ProPharma unlock the mysteries of how AI works in visual inspection and provides insights into how to utilize A.I. technology to inspect and release GxP products in a compliant way.  \nIn this is free 1-hour webinar\, you will learn: \n\nThe current regulatory thinking on the use of A.I.\nWhat is an image and the image evaluation process\nWhat is a contaminant\nChallenges and solutions to visual inspection\n\nYou will discover the methodology for utilizing A.I. and how it can be validated for processing. This webinar also provides you with a visual representation of how A.I. utilizes images to assess the pass / fail standards and how those standards are maintained for simple products such as clear liquids and more complex applications like blood and plasma products.   \nValidating AI for Visual Webinar Topics   \n\nHow Artificial Intelligence (A.I.) is utilized to detect foreign materials\nWhy AI is critical to assure safe drug supply\nHow AI for Visual Inspection is implemented on IV bags and non-standard products\nHow Visual Inspection with AI is validated per regulatory requirements\nModifications required for AI to analyze difficult products including blood\nConsiderations to resolve challenges of AI for blood\, cell and gene therapies\n\nInstructors\nRobert Beall\nVice President ProPharma Cell and Gene Therapy Center of Excellence\nRobert W. Beall – Vice President\, ProPharma Group has 35+ years of industry experience. Robert has supported the development and commercialization of multiple cell therapy products and processes including decentralization of CD19+ CAR T therapies\, development of hospital cellular therapy labs\, including expansion of the NIH Center for Cellular Engineering\, as well as the expansion of the first commercialized CAR-T therapy process capabilities. Other Cell therapy programs included remediation support for cellular and media manufacturing programs\, and guidance for multiple CAR-T manufacturing automation advancements. Robert supported the COVID-19 response by establishing global safety systems for three major vaccines.  He has led hundreds of international product transfers utilizing both internal transfers and CMO’s at multiple top 10 Pharmaceutical companies. He is a graduate of the Rochester Institute of Technology (RIT) with a BS in Engineering and has completed advanced degree studies as well as completing his PMP certification.  He is an international speaker and author. \nFilippo Begarani\nResearch and Innovation Manager\nFilippo Begarani is Head of Innovation at PBL SRL\, overseeing new technology development. He serves on the Supervisory Board of Italy’s National Research Centre for Gene Therapy and RNA-based Drugs. Previously CEO of Omnidermal Biomedics\, he led AI-based medical device development for skin ulcer monitoring. He holds a PhD in Molecular Biophysics from Scuola Normale Superiore\, Italy\, and an MSc in Electronic Engineering with a focus on nanotechnology from leading European universities. \n \nCost: Free \nClick here to read the full description \nFor best results\, use a Chrome browser when registering.
URL:https://validationcenter.com/courses/validating-ai-for-visual-inspections-webinar-may-2025/
LOCATION:Online
CATEGORIES:Validating AI for Visual Inspection
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Chicago:20250522T110000
DTEND;TZID=America/Chicago:20250522T123000
DTSTAMP:20260405T060006
CREATED:20241106T211400Z
LAST-MODIFIED:20241106T211400Z
UID:10000250-1747911600-1747917000@validationcenter.com
SUMMARY:Auditing Software Vendors Webinar - May 2025
DESCRIPTION:Follow a Proven Process for Auditing Your Software Vendors\nFree webinar on software vendor audit topics including\, audit terminology\, when and how to audit vendors\, how to leverage audit results to reduce validation efforts\, and FDA Warning Letters regarding software vendors. \nDuration: 1.5 Hours \nClick here to read the full description \nFor best results\, use a Chrome browser when registering.
URL:https://validationcenter.com/courses/auditing-software-vendors-webinar-may-2025/
LOCATION:Online
CATEGORIES:Auditing Software Vendors
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Amsterdam:20250521T160000
DTEND;TZID=Europe/Amsterdam:20250521T173000
DTSTAMP:20260405T060006
CREATED:20250114T141343Z
LAST-MODIFIED:20250205T213525Z
UID:10000168-1747843200-1747848600@validationcenter.com
SUMMARY:Validation of and/or through AI: How To Launch a successful Software as a Medical Device - May 2025
DESCRIPTION:AI SaMD Validation: Balancing Innovation and Compliance\nLearn the basics of validation and regulatory compliance for artificial intelligence (AI) software for use as a medical device.  This webinar covers the applicable regulations for AI SaMD\, as well as related guidance from health authorities.  The webinar provides an introduction to computer system validation and software assurance approaches for SaMD AI to accelerate the testing stages of the development process. \nTime: 4:00 PM – 5:30 PM CET (9:00-10:30 AM CST) Not your time zone? Try this converter tool. \nDuration: 1.5 hours \nRead more about this course
URL:https://validationcenter.com/courses/validation-of-and-or-through-ai-how-to-launch-a-successful-software-as-a-medical-device-may-2025/
LOCATION:Online
CATEGORIES:AI Validation
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Amsterdam:20250519T140000
DTEND;TZID=Europe/Amsterdam:20250520T180000
DTSTAMP:20260405T060006
CREATED:20241106T141625Z
LAST-MODIFIED:20250319T203230Z
UID:10000240-1747663200-1747764000@validationcenter.com
SUMMARY:All About Data Integrity by Design (Live\, Online) - May 2025
DESCRIPTION:Create Systems that Uphold Integrity from the Ground Up\nLearn how to architect and develop data systems that prioritize integrity\, avoiding errors and maintaining accuracy from the outset. \nTime: 14:00h – 18:00h Central European Time (CET) each day / 8:00 AM – 12:00 PM US Eastern Time (ET) each day (Not your time zone? Try this time zone conversion tool) \nRead more about this class
URL:https://validationcenter.com/courses/all-about-data-integrity-by-design-live-online-may-2025/
LOCATION:Online
CATEGORIES:All About Data Integrity by Design
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Chicago:20250512T120000
DTEND;TZID=America/Chicago:20250513T153000
DTSTAMP:20260405T060006
CREATED:20241106T141516Z
LAST-MODIFIED:20241106T141815Z
UID:10000233-1747051200-1747150200@validationcenter.com
SUMMARY:Intro to Computer System Validation (CSV) - USA - May 2025
DESCRIPTION:Learn the Essential Elements to Efficient Validation Protocols and Documentation\nLearn to develop precise and effective validation protocols\, documentation\, and reports\, essential for streamlined and successful system validation processes. \nTime: 12:00 PM – 3:30 PM US Central Time each day. Not your time zone? Try this tool. \nRead more about this class
URL:https://validationcenter.com/courses/intro-to-computer-system-validation-csv-usa-may-2025/
LOCATION:Online
CATEGORIES:Introduction to CSV
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Amsterdam:20250512T103000
DTEND;TZID=Europe/Amsterdam:20250514T160000
DTSTAMP:20260405T060006
CREATED:20241106T141516Z
LAST-MODIFIED:20241106T141819Z
UID:10000234-1747045800-1747238400@validationcenter.com
SUMMARY:Computer System Validation (CSV) for Cloud/COTS - EU - May 2025
DESCRIPTION:Learn to Validate for Your Cloud-based\, SaaS\, COTS\, or OOTB Application\nThis class has been designed to ensure that you leave knowing what to validate\, how to validate\, and when to leverage vendor-supplied documentation in your validation. You will also learn the necessity and power of vendor assessments and risk-based validation. \nTime: 10:30 AM – 4:00 PM Central European Time each day (8:30-2:00 PM PT / 11:30-5:00 PM ET) Not your time zone? Try this converter tool. \nRead more about this course
URL:https://validationcenter.com/courses/computer-system-validation-csv-for-cloud-cots-eu-may-2025/
LOCATION:Online
CATEGORIES:CSV for Cloud and COTS Applications
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Amsterdam:20250507T100000
DTEND;TZID=Europe/Amsterdam:20250507T113000
DTSTAMP:20260405T060006
CREATED:20241106T141516Z
LAST-MODIFIED:20241106T141516Z
UID:10000232-1746612000-1746617400@validationcenter.com
SUMMARY:Introduction to Annex 11 Webinar - EU - May 2025
DESCRIPTION:Learn How to be Compliant with Annex 11\nIn this free webinar\, you will learn key EU terminology fundamental for understanding Annex 11 as well as the history of Annex 11. We will walk through the detailed requirements of Annex 11 and explore approaches and processes for achieving compliance. You will come to appreciate where the requirements of Annex 11 are similar to Part 11\, and where they differ. And finally\, we will review related EU regulations and guidance\, and explain how Annex 11 is being applied to US companies via PIC/S. \nDuration: 1.5 hours \nRead the full course description \nFor best results\, use a Chrome browser when registering.
URL:https://validationcenter.com/courses/introduction-to-annex-11-webinar-eu-may-2025/
LOCATION:Online
CATEGORIES:Annex 11
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Chicago:20250506T110000
DTEND;TZID=America/Chicago:20250506T123000
DTSTAMP:20260405T060006
CREATED:20241106T211403Z
LAST-MODIFIED:20241106T211403Z
UID:10000251-1746529200-1746534600@validationcenter.com
SUMMARY:Cloud and SaaS in GxP Webinar - May 2025
DESCRIPTION:Learn How Regulations Impact Your Cloud and SaaS Implementation\nIn this free webinar\, you will learn the basics of Cloud terminology and implementation models.  And\, we will show you how regulations such as 21 CFR 11\, 21 CFR 820\, and Annex 11 can impact the model you choose. \nDuration: 1.5 hours \nClick here to read the full description  \nFor best results\, use a Chrome browser when registering.
URL:https://validationcenter.com/courses/cloud-and-saas-in-gxp-webinar-may-2025/
LOCATION:Online
CATEGORIES:Cloud and SaaS Validation
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Chicago:20250501T110000
DTEND;TZID=America/Chicago:20250501T123000
DTSTAMP:20260405T060006
CREATED:20241211T200438Z
LAST-MODIFIED:20241211T200438Z
UID:10000165-1746097200-1746102600@validationcenter.com
SUMMARY:Best-in-Class Documentation for CSV Program - May 2025
DESCRIPTION:Free Webinar \nComputer Systems Validation (CSV) is required by the FDA and many other international regulatory agencies. However\, it is often unclear what steps to take to implement a successful Computer Systems Validation Program.\nIn this 1-hour free webinar\, you will learn: \n\nHow to establish and structure an effective CSV Program?\nWhich high-quality documents need to be created and maintained for a successful CSV Program?\nWhat are the required Standard Operating Procedures (SOPs) and how to create them?\nWhat content should be included in which CSV document?\nWhat makes CSV deliverables\, SOPs\, and templates “best-in-class”?\nWhat auditors are looking for a successful CSV Program?\n\nYou will discover common mistakes and how you can avoid them. This webinar also provides you with a walk-through process of Computer System Validation key deliverables. \nComputer System Validation Webinar Topics\n\nWhat are the steps you need to take to implement a Computer System Validation program?\nWhat is the best structure for CSV Program Documents and Tools?\nWhat is Global Policy? What are the examples?\nWhat is Validation Master Plan? How to create it?\nWhat is an SOP? What are the SOPs required for CSV and how to create them?\nWhat is Work Instruction (WI)?\nWhat are the CSV templates you should develop? What content should be included?\nWhy should you have a successful CSV Program?\n\nCost: FREE
URL:https://validationcenter.com/courses/best-in-class-documentation-for-csv-program-may-2025/
LOCATION:Online
CATEGORIES:Best-in-Class Documentation for CSV Program Classes
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Amsterdam:20250428T130000
DTEND;TZID=Europe/Amsterdam:20250429T163000
DTSTAMP:20260405T060006
CREATED:20241106T141515Z
LAST-MODIFIED:20241106T141842Z
UID:10000231-1745845200-1745944200@validationcenter.com
SUMMARY:Intro to Computer System Validation (CSV) (Live\, Online) EU - April 2025
DESCRIPTION:Navigating Software Validation with Ease\nLearn the intricacies of various regulatory standards\, including FDA\, EMA\, and ICH\, to equip yourself with the knowledge needed for ensuring compliance within computer system validation processes. \nTime: 1:00 PM – 4:30 PM Central European Time each day. Not your time zone? Try this tool. \nRead more about this class
URL:https://validationcenter.com/courses/intro-to-computer-system-validation-csv-live-online-eu-april-2025/
LOCATION:Online
CATEGORIES:Introduction to CSV
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Chicago:20250424T140000
DTEND;TZID=America/Chicago:20250424T153000
DTSTAMP:20260405T060006
CREATED:20241106T211405Z
LAST-MODIFIED:20241106T211405Z
UID:10000252-1745503200-1745508600@validationcenter.com
SUMMARY:Risk-Based Approach to Software Quality & Validation Webinar - April 2025
DESCRIPTION:Learn a Risk-Based Approach for Your Next CSV Project\nFree webinar on risk management topics including terminology\, FDA guidance\, practical method of risk assessment\, approaches for risk-based computer system validation\, and examples of FDA Warning Letters regarding risk management. \nDuration: 1.5 Hours \nClick here to read the full description \nFor best results\, use a Chrome browser when registering.
URL:https://validationcenter.com/courses/risk-based-approach-to-software-quality-validation-webinar-april-2025/
LOCATION:Online
CATEGORIES:Risk Based Approach
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Amsterdam:20250416T100000
DTEND;TZID=Europe/Amsterdam:20250416T100000
DTSTAMP:20260405T060006
CREATED:20241125T201112Z
LAST-MODIFIED:20241217T191237Z
UID:10000261-1744797600-1744797600@validationcenter.com
SUMMARY:Electronic Data Integrity Webinar – April 2025
DESCRIPTION:Prevent or Remediate Electronic Data Integrity Gaps in Your Organization\nFree webinar on the history of data integrity regulations and guidelines\, along with examples of where to look for electronic Data Integrity risks in your organization. \nDuration: 1.5 Hours \nRead the full description \nFor best results\, use a Chrome browser when registering.
URL:https://validationcenter.com/courses/electronic-data-integrity-webinar-april-2025/
LOCATION:Online
CATEGORIES:Electronic Data Integrity
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Chicago:20250415T140000
DTEND;TZID=America/Chicago:20250415T153000
DTSTAMP:20260405T060006
CREATED:20241106T211406Z
LAST-MODIFIED:20241106T211406Z
UID:10000253-1744725600-1744731000@validationcenter.com
SUMMARY:Computer Software Assurance (CSA) Principles Webinar - April 2025
DESCRIPTION:Upgrade your CSV Program with Computer Software Assurance: A Practical Approach\nLearn about Computer Software Assurance (CSA) and how it can be used to update your current computer system validation (CSV) program to meet regulatory requirements. The webinar covers the CSA approach for identifying a system’s intended use\, categorizing use\, identifying software failure risks\, and classifying these risks for subsequent assurance activities\, along with providing relatable examples and real-life scenarios. \nDuration: 1.5 hours \nClick here to read the full description \nFor best results\, use a Chrome browser when registering.
URL:https://validationcenter.com/courses/computer-software-assurance-csa-principles-webinar-april-2025/
LOCATION:Online
CATEGORIES:Computer Software Assurance
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Chicago:20250410T110000
DTEND;TZID=America/Chicago:20250410T120000
DTSTAMP:20260405T060006
CREATED:20250226T190210Z
LAST-MODIFIED:20250313T193956Z
UID:10000169-1744282800-1744286400@validationcenter.com
SUMMARY:Controlled Temperature Chambers Webinar - April 2025
DESCRIPTION:Join our Controlled Temperature Chamber Webinar\nThis webinar covers the regulations from WHO\, USP\, PDA\, FDA\, and others regarding the validation of various chambers through temperature mapping and monitoring. It will explore chamber types\, data loggers\, warehouse mapping\, Mean Kinetic Temperature (MKT)\, and the unique requirements of cold chain logistics for shipping validation. \nDuration: 1 Hour \nClick here to read the full description \nFor best results\, use a Chrome browser when registering.
URL:https://validationcenter.com/courses/controlled-temperature-chambers-webinar-april-2025/
LOCATION:Online
CATEGORIES:Controlled Temperature Chambers
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Chicago:20250407T103000
DTEND;TZID=America/Chicago:20250409T160000
DTSTAMP:20260405T060006
CREATED:20241106T141515Z
LAST-MODIFIED:20241106T141851Z
UID:10000230-1744021800-1744214400@validationcenter.com
SUMMARY:Computer System Validation (CSV) for Cloud/COTS - USA - April 2025
DESCRIPTION:Navigating CSV in COTS Environments: A Comprehensive Guide\nThis class has been designed to help you understand CSV Methodologies Tailored for Commercial Off-The-Shelf (COTS) Applications. We’ll share more about the nuances of implementing CSV specifically for COTS applications\, providing a roadmap for compliance and smooth integration in diverse software environments. \nTime: 10:30 AM – 4:00 PM US Central Time each day (8:30-2:00 PM PT / 11:30-5:00 PM ET) Not your time zone? Try this converter tool. \nRead more about this course
URL:https://validationcenter.com/courses/computer-system-validation-csv-for-cloud-cots-usa-april-2025/
LOCATION:Online
CATEGORIES:CSV for Cloud and COTS Applications
END:VEVENT
END:VCALENDAR