

# Event Details

- **Event Name**: Reduce costs for compliance with data integrity: 21 CFR Part 11, SaaS/Cloud, EU GDPR
- **Event Start and End Date**: Wed, 04 Feb, 2026 at 09:00 am – Thu, 05 Feb, 2026 at 03:00 pm
- **Event Description**: For Agenda &amp; Event Registration Visit: https://www.complianceonline.com/computer-system-validation-reduce-costs-and-avoid-483s-seminar-training-80005SEM-prdsm?channel=alleventsUse coupon COMPLIANCE15 to get 15% discount on this virtual seminarAfter registration ComplianceOnline customer care will contact you on a day before the event with event link and proceedingsThis highly interactive two-day course uses real life examples and explores proven techniques for reducing costs, usually by two-thirds, associated with implementing, and maintaining computer systems in regulated environments.It details the requirements for Part 11 and Annex 11: SOPs, software product features, infrastructure qualification, and validation.The instructor addresses the latest computer system industry standards for data security, data transfer, audit trails, electronic records and signatures, software validation, and computer system validation.Understand the specific requirements associated with local and SaaS/cloud hosting solutions.Nearly every computerized system used in laboratory, clinical, manufacturing settings and in the quality process has to be validated. Participants learn how to decrease software implementation times and lower costs using a 10-step risk-based approach to computer system validation.The instructor reviews recent FDA inspection trends and discusses how to streamline document authoring, revision, review, and approval.Participants will learn how to write a Data Privacy Statement to comply with the EU General Data Protection Regulation (GDPR).This course benefits anyone that uses computer systems to perform their job functions and is ideal for professionals working in the health care, clinical trial, biopharmaceutical, and medical device sectors. It is essential for software vendors, auditors, and quality staff involved in GxP applications. Learning Objectives:Reduce costs, usually by two-thirds, for compliance with electronic recordsLearn how to use electronic records and electronic signatures to maximize productivityUnderstand what is expected in Part 11 and Annex 11 inspections so you are preparedAvoid 483 and Warning LettersUnderstand the responsibilities and specific duties of your staff including IT and QAUnderstand your responsibilities and liabilities when using SaaS/cloudLearn how to perform risk-based Computer System Validation using fill-in-the-blank templatesHow to select resources and manage validation projects"Right size" change control methods that allows quick and safe system evolutionMinimize validation documentation to reduce costs without increasing regulatory or business riskLearn how to reduce testing time and write test cases that trace to elements of risk managementLearn how to comply with the requirements for data privacyLearn how to buy COTS software and qualify vendorsProtect intellectual property and keep electronic records safeWho will Benefit:GMP, GCP, GLP, regulatory professionalsQA/QCITAuditorsManagers and directorsSoftware vendors, SaaS hosting providers
- **Event URL**: https://allevents.in/sunnyvale/reduce-costs-for-compliance-with-data-integrity-21-cfr-part-11-saas-cloud-eu-gdpr/80003092921527
- **Event Categories**: workshops, nonprofit, health-wellness, trips-adventures
- **Interested Audience**: 
  - total_interested_count: 0

## Ticket Details

- **Ticket URL**: https://www.complianceonline.com/computer-system-validation-reduce-costs-and-avoid-483s-seminar-training-80005SEM-prdsm?channel=allevents

## Event venue details

- **city**: Sunnyvale
- **state**: CA
- **country**: United States
- **location**: MetricStream Inc.
- **lat**: 37.4180315
- **long**: -121.9791885
- **full address**: MetricStream Inc., 6201 America Center Dr, Sunnyvale, CA 94089, United States

## Event Organizer details

- **affiliate_id**: 8
- **organizer**: ComplianceOnline (https://allevents.in/org/complianceonline/12919563)

## Event gallery

- **Alt text**: banner
  - **Image URL**: https://cdn2.allevents.in/thumbs/thumb694286b94442f.jpg
- **Alt text**: thumbnail
  - **Image URL**: https://dyn-image.allevents.in/generate-image?v=4&title=Reduce+costs+for+compliance+with+data+integrity%3A+21+CFR+Part+11%2C+SaaS%2FCloud%2C+EU+GDPR&date=04+Feb

## FAQs

- **Q**: When is the event happening?
  - **A:** Wed, 04 Feb, 2026 at 09:00 am
- **Q**: Where is the event happening?
  - **A:** MetricStream Inc., 6201 America Center Dr, Sunnyvale, CA 94089, United States
- **Q**: Who is organizing the event?
  - **A:** ComplianceOnline
- **Q**: What type of event is this?
  - **A:** workshops, nonprofit, health-wellness, trips-adventures
- **Q**: Where can I find ticket details about Reduce costs for compliance with data integrity: 21 CFR Part 11, SaaS/Cloud, EU GDPR ?
  - **A:** You can find ticket details about this event on AllEvents.

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