Training Doyens

OVERVIEW FDA requires that all computer systems used to produce, manage and report on  GxP (GMP, GLC, GCP)  related products be validated and maintained in accordance with FDA system validation rules . You’ll learn all about how to create and maintain good FDA-compliant documentation using a strategic approach based on the  System Development Life Cycle (SDLC) Methodology . The webinar will leave you with the information needed for planning, executing and documenting a computer system validation effort that meets FDA compliance standards. You will learn about the computer system validation requirements and what must be done to ensure the system remains in a validated state. In addition, you’ll learn about the various computer system validation deliverables and how to document them through the entire process. WHY SHOULD YOU ATTEND This webinar will help you understand in detail  Computer System Validation (CSV)  and how to apply the  System ...

OVERVIEW According to the FDA requirements all software in computer systems used in GxP activities must be validated. Validation of computer system software is completely different than validation of device software (embedded software). Computersystem validation is more than testing. It is testing plus design control and configuration management. How to plan and conduct a risk based validation will be explained. Overall risk for computer system is a combination of software complexity and product risk as determined by probability, severity and detectability rankings. Also involved in the risk evaluation is the requirement for purchased software supplier qualification. In this computer system validation training you’ll learn how to integrate risk based supplier evaluation into the computer system validation process. Validation Master plan and System Validation Plans will be explained. Testing, based on risk, includes requirements validation and IQ, OQ and PQ. A procedure for e...

OVERVIEW This webinar will help you understand in detail Computer System Validation (CSV) and how to apply the System Development Life Cycle (SDLC) Methodology when validating computer systems subject to FDA regulations. This is critical in order to develop the appropriate validation strategy and achieve the thoroughness required to prove that a system does what it purports to do. It also ensures that a system is maintained in a validated state throughout its entire life cycle, from conception through retirement. We will discuss the phases within the SDLC, and how these form the basis for any CSV project. The importance of the sequence of steps will also be covered. WHY SHOULD YOU ATTEND An FDA inspection or audit is something to take very seriously, and it’s important to have all computer systems that are regulated by FDA fully validated.  In this webinar, you will learn how to validate computer systems in compliance with FDA’s guidelines and also how to maintain them ...

OVERVIEW This Computer System Validation Training will explore proven techniques for reducing costs associated with implementing, using, and maintaining computer systems in regulated environments. Today, the FDA performs both GxP and Part 11 inspections, the Europeans have released an updated Annex 11 regulation that expands Part 11 requirements and companies must update their systems and processes to maintain compliance. Many companies outsource IT resources and are involved in Software as a Service (SaaS) and cloud computing. These vendors are not regulated, and therefore, regulated companies must ensure compliance for both infrastructure qualification and computer system validation to avoid FDA form 483s and Warning Letters. Computer System Validation WHY SHOULD YOU ATTEND Upon completing this course participants should: Understand what is expected in Part 11 and Annex 11 inspections How to avoid 483s and Warning Letters How to implement a computer system u...