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The workshop titled "Data Integrity and Privacy: Compliance with 21 CFR Part 11, SaaS/Cloud, EU GDPR" is organized by ComplianceIQ and is designed to equip participants with essential knowledge for navigating the complexities of data integrity and privacy regulations. This online workshop focuses on the compliance requirements of 21 CFR
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Part 11, which governs the use of electronic records and signatures in the United States, and the European equivalent, Annex 11. Attendees will gain insights into how to seamlessly transition from paper-based systems to electronic forms while maintaining compliance and enhancing productivity.
The workshop covers critical topics, including the responsibilities of software vendors and hosting providers, the writing of Data Privacy Statements to comply with the EU General Data Protection Regulation (GDPR), and the necessary Standard Operating Procedures (SOPs) for IT infrastructure. Participants will learn about the primary compliance areas such as software features, infrastructure qualification, and validation requirements for local, SaaS, and cloud-hosted applications. The session aims to clarify the regulations, explaining their implications beyond mere compliance, ensuring that attendees understand what is required to achieve and maintain compliance. Additionally, David Nettleton, an industry leader in computer system validation and the author of "Risk Based Software Validation - Ten Easy Steps," will lead the workshop. With extensive experience in the implementation of FDA-compliant systems, Nettleton will share valuable insights into reducing validation resources and the critical features to consider when purchasing commercial off-the-shelf (COTS) software. The event targets regulatory professionals from various sectors, including GMP, GCP, and GLP, and is expected to reach audiences in Belgium, the USA, and South Africa.
The workshop covers critical topics, including the responsibilities of software vendors and hosting providers, the writing of Data Privacy Statements to comply with the EU General Data Protection Regulation (GDPR), and the necessary Standard Operating Procedures (SOPs) for IT infrastructure. Participants will learn about the primary compliance areas such as software features, infrastructure qualification, and validation requirements for local, SaaS, and cloud-hosted applications. The session aims to clarify the regulations, explaining their implications beyond mere compliance, ensuring that attendees understand what is required to achieve and maintain compliance. Additionally, David Nettleton, an industry leader in computer system validation and the author of "Risk Based Software Validation - Ten Easy Steps," will lead the workshop. With extensive experience in the implementation of FDA-compliant systems, Nettleton will share valuable insights into reducing validation resources and the critical features to consider when purchasing commercial off-the-shelf (COTS) software. The event targets regulatory professionals from various sectors, including GMP, GCP, and GLP, and is expected to reach audiences in Belgium, the USA, and South Africa.
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Timings09:00 AM-06:00 PM (expected)Not Verified | Entry FeesCheck Official Website |
Estimated Turnout100 - 500 Delegates Based on previous editions | Official LinksWebsiteContacts
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EditionsJul 2025+17 more editions Frequency Quarterly Next edition likely in Oct 2025 | Report Error Claim this event |
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Jul 182025
Aug 122025