This Event has Passed
Thursday, June 18, 2020
1:00 PM - 2:30 PM
1:00 PM - 2:30 PM See all dates and Times
https://bit.ly/2TrqbCe
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 FDA 21 CFR Part 11. 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 webinar 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
AREAS COVERED
• Computer System Validation (CSV)
• System Development Life Cycle (SDLC) methodologies
• Good “Variable” Practice (GxP) (Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), Good Clinical Practice (GCP))
LEARNING OBJECTIVES
• Gain an understanding of FDA’s 21 CFR Part 11 Electronic Records/Electronic Signatures (ER/ES) guidance document
• Develop the ability to apply 21 CFR Part 11 regulations when implementing, validating and maintaining computer systems in your organization
• Understand the best practices for maintaining a computer system with ER/ES capability in a validated state
WHO WILL BENEFIT
• Information Technology Analysts
• QC/QA Managers
• QC/QA Analysts
• Clinical Data Managers
• Clinical Data Scientists
• Analytical Chemists
• Compliance Managers
• Laboratory Managers
To Register (or) for more details please click on this below link:
https://bit.ly/2TrqbCe
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 webinar 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
AREAS COVERED
• Computer System Validation (CSV)
• System Development Life Cycle (SDLC) methodologies
• Good “Variable” Practice (GxP) (Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), Good Clinical Practice (GCP))
LEARNING OBJECTIVES
• Gain an understanding of FDA’s 21 CFR Part 11 Electronic Records/Electronic Signatures (ER/ES) guidance document
• Develop the ability to apply 21 CFR Part 11 regulations when implementing, validating and maintaining computer systems in your organization
• Understand the best practices for maintaining a computer system with ER/ES capability in a validated state
WHO WILL BENEFIT
• Information Technology Analysts
• QC/QA Managers
• QC/QA Analysts
• Clinical Data Managers
• Clinical Data Scientists
• Analytical Chemists
• Compliance Managers
• Laboratory Managers
To Register (or) for more details please click on this below link:
https://bit.ly/2TrqbCe
Email: [email protected]
Toll Free: +1-888-300-8494
Tel: +1-720-996-1616
Fax: +1-888-909-1882
