Data Integrity by Design and Pharma 4.0: Next-Gen Techniques to Approach GxP Systems, and FDA Compliance

Data Integrity by Design is an essential concept that businesses must embrace to ensure data integrity throughout the entire lifecycle of their computerized systems. From initial planning to implementation, operation, and retirement, it requires critical thinking to identify and mitigate risks that could compromise patient safety and product quality.

For businesses that rely on advanced process control, automation, artificial intelligence (AI), and machine learning, powerful data management is crucial. That's where an integrated laboratory software system comes in, streamlining processes and promoting data integrity to drive organizations towards a Pharma 4.0 strategy.

This seminar is designed for professionals involved in computer system validation activities within FDA-regulated industries such as pharmaceuticals, medical devices, biologics, and tobacco products, including e-liquids, e-cigarettes, pouch tobacco, cigars, and more. Relevant functions include research and development, manufacturing, quality control, distribution, clinical testing, regulatory affairs, adverse event management, and post-marketing surveillance.

The program offers a comprehensive view of the industry and the FDA's response to ever-evolving technologies, including insights into how Pharma 4.0™ enables the development of next-generation medicinal products and new business models for established products. Key factors for success in this initiative include organizational, cultural, and technical processes and resources.

• Information Technology Analysts
• Information Technology Developers and Testers
• Software Quality Assurance Professionals
• QC/QA Managers and Analysts
• Analytical Chemists
• Compliance and Audit Managers
• Laboratory Managers
• Automation Analysts
• Manufacturing Specialists and Managers
• Supply Chain Specialists and Managers
• Regulatory Affairs Specialists
• Regulatory Submissions Specialists
• Risk Management Professionals
• Clinical Data Analysts
• Clinical Data Managers
• Clinical Trial Sponsors
• Computer System Validation Specialists
• GMP Training Specialists
• Business Stakeholders/Subject Matter Experts
• Business System/Application Testers
• Vendors responsible for software development, testing and maintenance
• Vendors and consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance

DAY 1 (10 AM to 3 PM)

• “GxP” Computer Systems and FDA Oversight
• Computers and Data Integrity
• FDA Inspection Trends and Data Integrity
• Computer System Validation (CSV)
• CSV Maintenance
• FDA's 21 CFR Part 11 (Electronic Records/Electronic Signatures) Guidance
• The “12 Theses” of Pharma 4.0
• Pharma 4.0 vs. Industry 4.0 - Similarities, Differences and Best Practices
• Q&A

DAY 2 (10 AM to 3 PM)

• 6 ways to improve Productivity and Quality
• Investment calculations for Pharma 4.0
• Prerequisites for Pharma 4.0
• Pharma 4.0 Operating Model
• Pharma 4.0 Maturity Model
• Digital Transformation
• Overcoming DI issues in Cloud
• Pharma 4.0 – The Future
• Q&A

Carolyn Troiano has more than 30 years of experience in computer system validation in the pharmaceutical, medical device, animal health, tobacco and other FDA-regulated industries. She is currently an independent consultant, advising companies on computer system validation and large-scale IT system implementation projects.

During her career, Carolyn worked directly, or on a consulting basis, for many of the larger pharmaceutical companies in the US and Europe. She developed validation programs and strategies back in the mid-1980s, when the first FDA guidebook was published on the subject, and collaborated with FDA and other industry representatives on 21 CFR Part 11, the FDA’s electronic record/electronic signature regulation.

Carolyn has participated in industry conferences. She is currently active in the PMI, AITP, and RichTech, and volunteers for the PMI’s Educational Fund as a project management instructor for non-profit organizations.