This Event has Passed
Tuesday, July 14, 2020
1:00 PM - 2:30 PM
1:00 PM - 2:30 PM See all dates and Times
https://bit.ly/3fqLhJA
OVERVIEW The Webinar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11 regulations. This includes development of a company philosophy and approach, and incorporating it into the overall computer system validation program and plans for individual systems that have this capability.
WHY SHOULD YOU ATTEND
You should attend this seminar if you are responsible for planning, executing or managing the implementation of any system governed by FDA regulations that uses ER/ES capability, or if you are maintaining or supporting such a system.
Effective and compliant computer system validation is critical to any pharmaceutical or FDA-regulated organization. During the past 30 years, best practices that have been developed will ensure that validation activities are cost-effective while meeting all aspects of FDA compliance.
AREAS COVERED
• Computer System Validation (CSV)
• System Development Life Cycle (SDLC) Methodology
• Good “Variable” Practice (GxP) (Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), Good Clinical Practice (GCP))
• Validation strategy
LEARNING OBJECTIVES
• Understand some of the key “pitfalls” to avoid when employing ER/ES capability
• Understand the best practices for maintaining a computer system with ER/ES capability in a validated state
• Discuss the best practices necessary to ensure all systems with ER/ES capability are validated appropriately
WHO WILL BENEFIT
• Information Technology Analysts
• QC/QA Managers
• QC/QA Analysts
• Clinical Data Managers
• Clinical Data Scientists
• Analytical Chemists
• Compliance Managers
• Laboratory Managers
• Automation Analysts
• Computer System Validation Specialists
To Register (or) for more details please click on this below link:
https://bit.ly/3fqLhJA
Email: [email protected]
Toll Free: +1-888-300-8494
Tel: +1-720-996-1616
Fax: +1-888-909-1882
WHY SHOULD YOU ATTEND
You should attend this seminar if you are responsible for planning, executing or managing the implementation of any system governed by FDA regulations that uses ER/ES capability, or if you are maintaining or supporting such a system.
Effective and compliant computer system validation is critical to any pharmaceutical or FDA-regulated organization. During the past 30 years, best practices that have been developed will ensure that validation activities are cost-effective while meeting all aspects of FDA compliance.
AREAS COVERED
• Computer System Validation (CSV)
• System Development Life Cycle (SDLC) Methodology
• Good “Variable” Practice (GxP) (Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), Good Clinical Practice (GCP))
• Validation strategy
LEARNING OBJECTIVES
• Understand some of the key “pitfalls” to avoid when employing ER/ES capability
• Understand the best practices for maintaining a computer system with ER/ES capability in a validated state
• Discuss the best practices necessary to ensure all systems with ER/ES capability are validated appropriately
WHO WILL BENEFIT
• Information Technology Analysts
• QC/QA Managers
• QC/QA Analysts
• Clinical Data Managers
• Clinical Data Scientists
• Analytical Chemists
• Compliance Managers
• Laboratory Managers
• Automation Analysts
• Computer System Validation Specialists
To Register (or) for more details please click on this below link:
https://bit.ly/3fqLhJA
Email: [email protected]
Toll Free: +1-888-300-8494
Tel: +1-720-996-1616
Fax: +1-888-909-1882
