Data Integrity and Privacy - Compliance with 21 CFR Part 11, SaaS/Cloud, EU GDPR-

Overview:

In today's rapidly evolving life sciences landscape, ensuring data integrity and privacy has become a critical priority for organizations striving to maintain compliance with increasingly stringent regulations. As we navigate through 2024, the challenges surrounding data integrity and privacy have only intensified, with regulatory bodies like the FDA and EMA placing greater scrutiny on the reliability, accuracy, and security of data across various systems and platforms.

This timely webinar, led by industry expert David Nettleton, renowned for his extensive experience in regulatory compliance and data integrity, aims to provide pharmaceutical professionals with the knowledge, strategies, and tools necessary to navigate the complex landscape of data integrity and privacy compliance. The focus will be on 21 CFR Part 11, SaaS/Cloud, and EU GDPR regulations.

Recent studies have highlighted the alarming prevalence of data integrity issues within the life sciences industry. According to Redica Systems, data integrity was cited in a staggering 79% of drug warning letters over a five-year period, with the number of warning letters citing data integrity issues increasing more than fourfold. Furthermore, approximately 50% of all global drug 483s issued between 2014 and 2018 cited data integrity concerns. These statistics underscore the critical importance of understanding and complying with regulations such as 21 CFR Part 11, which sets standards for electronic records and signatures in FDA-regulated industries, and the EU GDPR, which establishes strict standards for data protection and privacy.

The consequences of data integrity violations can be severe, as emphasized by the International Society for Pharmaceutical Engineering (ISPE). From facility shutdowns and drug shortages to product recalls and significant financial losses, the impact of compromised data integrity can be far-reaching and devastating. The FDA's expectation that all data submitted for market approval be reliable and accurate further underscores the critical role of data integrity in ensuring the safety, efficacy, and quality of pharmaceutical/Medical Device products.

Moreover, the rapid adoption of cloud-based solutions and Software as a Service (SaaS) platforms has introduced new challenges and considerations for maintaining data integrity and privacy. Organizations must ensure that their systems and processes comply with the requirements of 21 CFR Part 11 and navigate the complexities of compliance across multiple jurisdictions and regulatory frameworks, including EU GDPR.

Through a deep dive into key areas, attendees will gain practical insights and actionable strategies to strengthen their organization's data integrity and privacy practices and mitigate the risk of costly regulatory violations.

Areas covered during the session:

• Which data and systems are subject to Part 11 and Annex 11
• How to write a Data Privacy Statement
• What the regulations mean, not just what they say
• Avoid 483 and Warning Letters
• Requirements for local, SaaS, and cloud hosting
• Understand the current industry standard software features for security, data transfer, audit trails, and electronic signatures
• How to use electronic signatures, ensure data integrity, and protect intellectual property
• SOPs required for the IT infrastructure
• Product features to look for when purchasing COTS software
• Reduce validation resources by using easy to understand fill-in-the-blank validation documents

Why You Should Attend?

This webinar offers an unparalleled opportunity to elevate your understanding of 21 CFR Part 11, SaaS/Cloud, and EU GDPR regulations. With data integrity cited in a significant portion of regulatory actions, including FDA warning letters and global drug 483s, the stakes for compliance have never been higher.

Attendees will learn to navigate the complex landscape of data integrity and privacy, acquiring the strategies and tools necessary to avert the severe repercussions of non-compliance. Whether you're facing challenges in adapting to cloud-based solutions or striving to ensure your systems meet rigorous regulatory standards, this session will provide you with actionable insights to fortify your data governance practices and safeguard your organization against costly violations.

Who Should Attend?

• Medical Device Manufacturers
• Quality Assurance Professionals
• Regulatory Affairs Professionals
• R&D Engineers
• IT and Cybersecurity Specialists
• Clinical Trial Managers
• Compliance Officers
• Software Vendors and Consultants