Training Doyens

OVERVIEW This webinar will leave you with the information needed to plan, execute and document a computer system validation effort that meets FDAcompliance standards.  You will learn about 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. FDA requires that all computer systems used to produce, manage and report on GxP (GMP, GLC, and GCP) related products be validated and maintained in accordance with specific 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. System Development Life Cycle Approach WHY SHOULD YOU ATTEND This FDA Compliance training will help you understand in detail Computer System Validation (CSV) and how to apply the System Development Life Cycle (SDLC) Me...

OVERVIEW This FDA compliance webinar will leave you with the information needed to create and maintain good documentation that meets FDA compliance standards.  You will learn about what must be done and what must not be done.  In addition, you’ll learn about the various computer system validation deliverables and how to document them through the entire process. FDA requires that all documentation related to GxP (GMP, GLC, and GCP) products be created and maintained in accordance with specific rules.  From the color of the ink used to the retention requirements, you’ll learn all about how to create and maintain good FDA-compliant documentation. Computer Systems Regulated by FDA WHY SHOULD YOU ATTEND You should attend this webinar if you are responsible for any FDA-regulated data and/or records.  All documents need to be created and maintained in accordance with FDA guidelines for good documentation to avoid any issues during an inspection or audit. ...

OVERVIEW This webinar will leave you with the information needed to create and maintain good documentation that meets FDAcompliance standards.  You will learn about what must be done and what must not be done.  In addition, you’ll learn about the various computer system validation deliverables and how to document them. FDA requires that all documentation related to GxP products (GMP, GLC, and GCP) be created and maintained in accordance with specific rules.  From the color of the ink used to the retention requirements, you’ll learn all about how to create and maintain good FDA-compliant documentation. FDA Computer System Validation WHY SHOULD YOU ATTEND You should attend this FDA regulatory compliance training if you are responsible for any FDA-regulated data and/or records.  All documents need to be created and maintained in accordance with FDA guidelines for good documentation to avoid any issues during an inspection or audit.  You will also b...

OVERVIEW You will learn how to take a strategic approach to validating computer systems that are regulated by FDA in a way that will be cost effective and efficient.  The webinar will go through the System Development Life Cycle (SDLC) methodology in detail, and we will demonstrate how the SDLC supports Computer System Validation (CSV). 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 ...