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

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Nov 15, 2023, 06:15 ET

DUBLIN, Nov. 15, 2023 /PRNewswire/ -- The "Data Integrity by Design and Pharma 4.0: Next-Gen Techniques to Approach GxP Systems, and FDA Compliance" training has been added to ResearchAndMarkets.com's offering.

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.

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.

The program offers a comprehensive view of the industry and the FDA's response to ever-evolving technologies, including insights into how Pharma 4.0T 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.

Attendees will learn about Pharma 4.0's various stages of maturity and how it can help break down silos and promote greater connectivity across organizations.

Who Should Attend:

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

"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

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

Speakers

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.

For more information about this training visit https://www.researchandmarkets.com/r/aauerq

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