In today's digital age, where data integrity and privacy are more critical than ever, it's essential for organizations to fully comprehend and comply with relevant regulations such as 21 CFR Part 11 in the U.S., its European counterpart Annex 11, and the EU General Data Protection Regulation (GDPR). Missteps in compliance not only lead to regulatory setbacks, like 483s and Warning Letters, but also put your data security and company reputation at substantial risk.
This timely and crucial webinar aims to serve as your comprehensive guide to navigating the often intricate requirements of these regulations. Whether you are dealing with local applications or SaaS/Cloud hosted solutions, the webinar will provide you with actionable insights to ensure you're on the right track for both electronic records and signatures, thereby significantly enhancing productivity while safeguarding compliance.
Why is this topic so relevant now? With the recent upsurge in cyber threats and data breaches, as well as the increased scrutiny from regulatory bodies, there's no room for error. These challenges are further compounded by the complex, and often confusing, language of legal and regulatory documents. That's why our expert David Nettleton— a seasoned professional with a deep understanding of these regulations—will decode what the laws mean in practice, not just in theory.
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
What 21 CFR Part 11 means today
- Purpose of Part 11
What does Part 11 mean?
- System features
- Infrastructure qualification
- Usernames and passwords
- Restrictions and logs
Data transfer standards
- Deleting data
Audit trail standards
- Types of data
- High risk systems
Electronic approval standards
- Electronic signatures
- Single sign-on
- Replacing paper with electronic forms
- How to efficiently document qualifications
- Software validation for vendors
- Computer system validation for users
- Fill-in-the-blank templates
- Change control re-validation
- Responsibilities for software vendor and hosting provider
- Evaluation criteria
- Hosting requirements
- IT, QA, validation
- Software development
- Comparison with Part 11
- Data Privacy Statement
Why Should You Attend?
In today's digital landscape, data integrity and privacy are not just buzzwords; they are necessities for any organization dealing with sensitive or regulated data. With stringent regulations like 21 CFR Part 11 in the United States and Annex 11 in the European Union, failure to adhere to compliance rules can result in severe penalties. Simultaneously, the rise of cloud and SaaS applications necessitates a new level of scrutiny and assurance that data is maintained with utmost integrity and in compliance with global standards like the EU's General Data Protection Regulation (GDPR).
This webinar serves as a one-stop resource for understanding the multifaceted compliance environment surrounding data integrity and privacy. Whether you're a data officer, a compliance auditor, or involved in the IT infrastructure, this session will demystify the requirements laid down by various regulations. We will provide you with the practical knowledge and tools you need to assess your existing systems, develop compliant SOPs, and understand what to look for in software features and infrastructure qualifications.\
Our hands-on approach will focus not just on what the regulations state, but what they mean in practice. Learn how to write an effective Data Privacy Statement for GDPR compliance and discover strategies for avoiding FDA Form 483s and Warning Letters. Additionally, we will cover how to evaluate vendors and hosting providers in the SaaS/Cloud space, ensuring you have a complete understanding of the responsibilities at stake. In summary, this webinar offers an indispensable guide to help you navigate the complexities of data integrity and privacy, ensuring your organization is compliant, efficient, and prepared for regulatory scrutiny.
What industries will benefit from this training:
- Medical Device
- FDA regulated companies
- Software Vendors
- SaaS providers
- Data Centers.
Who will benefit?
- GMP, GCP, GLP, regulatory professionals
- Managers and directors
- Software vendors, hosting providers
David Nettleton Computer System Validation’s principal, David Nettleton is an industry leader, author, and teacher for 21 CFR Part 11, Annex 11, HIPAA, EU General Data Protection Regulation (GDPR), software validation, and computer system validation.
Mr. Nettleton is involved with the development, purchase, installation, operation and maintenance of computerized systems used in FDA compliant applications. He has completed more than 300 mission critical laboratory, clinical, and manufacturing software implementation projects.
Mr. Nettleton recent book is Software as a Service (SaaS) Risk-Based Validation With Time-Saving Templates, which provides fill-in-the-blank templates for completing a COTS software validation project.