Data Integrity and Privacy: Compliance with 21 CFR Part 11, SaaS/Cloud, EU GDPR
Speaker: Carolyn Troiano
Speaker Designation: FDA Compliance Consultant
Speaker: Carolyn Troiano
Speaker Designation: FDA Compliance Consultant
In today's ever-changing landscape of technology, there are many new considerations for computer system validation (CSV) to ensure the nuances of each innovative component. For example, we now have more FDA-regulated companies starting to use cloud services and Software-as-a-Service (SaaS), Infrastructure-as-a-Service (IaaS), Platform-as-a-Service (PaaS), Software-as-a-Medical-Device (SaaMD), and the use of mobile devices.
We're seeing companies starting to move, as well, to an agile vs. waterfall approach for development and testing, and in some cases, they are using automated testing.
In addition, the FDA is encouraging companies to follow the principles of Computer Software Assurance (CSA) vs. the traditional CSV. There is a need to apply critical thinking and a discovery mindset as we do the validation activities. This means treating each requirement based on potential risk if it were to fail and doing testing for it accordingly.
In this webinar, we will review the current trends, including in technology and FDA compliance and enforcement. We'll look at Data Integrity, 21 CFR Part 11 (Electronic Records/Electronic Signatures), European Union (EU) Annex 11, General Data Protection Regulation (GDPR), and other regulatory requirements.
We'll walk through the validation process and provide a review of the potential pitfalls as well as best industry practices. This class will also cover the requirements for maintaining a computer system regulated by FDA in a validated state throughout its life cycle.
This webinar is intended for those involved in planning, execution, and support of computer system validation activities, working in the FDA-regulated industries, including pharmaceutical, medical device, biologics, tobacco, and tobacco-related products (e-liquids, e-cigarettes, pouch tobacco, cigars, etc.). Applicable functions include research and development, manufacturing, Quality Control, distribution, clinical testing and management, sample labeling, adverse events management, and post-marketing surveillance.
Personnel in the following roles will benefit:
Carolyn Troiano has more than 40 years of experience in computer systems and data in the pharmaceutical, medical device, tobacco, cannabis, and other FDA-regulated industries, as well as in banking, insurance, and government agencies. She is currently an independent consultant, advising companies on data integrity, privacy, and compliance, including implementing large-scale, complex systems, such as Enterprise Resource Planning (ERP), Customer Relationship Management (CRM), Clinical Trial Master File (TMF and eTMF), Manufacturing, Quality, and Enterprise Content Management (ECM) systems.