6-Hour Virtual Seminar on FDA Trends for Computer System Validation (CSV) Compliance and Enforcement – ResearchAndMarkets.com

Virtual Seminar on FDA Trends for Computer System Validation (CSV)
Compliance and Enforcement”
webinar has been added to ResearchAndMarkets.com’s

This webinar will focus on the key areas that are most important for
protecting the validity of data that is regulated by FDA, and is
typically housed electronically in computer systems. This includes how
to properly validate an FDA-regulated computer system in order to ensure
security and data integrity objectives are met. Implementing and
following the System Development Life Cycle (SDLC) methodology is the
best approach for Computer System Validation (CSV) and maintaining the
system in a validated state throughout its life.

The SDLC approach takes all aspects of validation into account
throughout the life of the system and protects the data that it houses
through its retention period. The data is a key asset for any
FDA-regulated company and must be protected. If data becomes invalid,
based on improperly validating and maintaining the system that houses it
in a validated state, the work related to the data would need to be
repeated. This could result in a devastating loss to any company’s
bottom line.

We will discuss the key areas that are most important during inspection
and audit, including security, data integrity, validation, training, and

Why you should attend

FDA requires that all computer systems that handle data regulated by the
Agency be validated in accordance with their guidance on computerized
systems. This guidance was first issued in 1983, and the main points of
focus remain consistent today, despite the number of years that have
passed and the technology changes that have taken place.

The guidance was revisited for its application to the medical device
industry in the 1990s, as the first issuance addressed pharmaceuticals
only. In 1997, 21 CFR Part 11 was issued to address electronic records
and signatures, as many FDA-regulated organizations began seeking ways
to move into a paperless environment. This guidance has been modified
over the years to make it more palatable to industry, and this includes
discretionary enforcement measures, but still remains somewhat
confusing. The intent was to avoid creating a huge regulatory compliance
cost to industry that was initially preventing companies from embracing
the technology.

This session will provide some insight into current trends in compliance
and FDA enforcement. Some are based on technology changes, and these
will continue to have an impact as new innovations come into use in the
industry. Others are based on factors including economics, social media,
new diseases, politics, and a host of other influences.

Who Should Attend:

  • Information Technology Analysts
  • Information Technology Managers
  • QC/QA Managers
  • QC/QA Analysts
  • Clinical Data Managers
  • Clinical Data Scientists
  • Analytical Chemists
  • Compliance Managers
  • Laboratory Managers
  • Automation Analysts
  • Manufacturing Managers
  • Manufacturing Supervisors
  • Supply Chain Specialists
  • Computer System Validation Specialists
  • GMP Training Specialists
  • Business Stakeholders responsible for computer system validation
    planning, execution, reporting, compliance, maintenance and audit
  • Consultants working in the life sciences industry who are involved in
    computer system implementation, validation and compliance
  • Auditors engaged in internal inspection


Session 1 (90 Mins):

  • FDA Regulatory Oversight
  • Computer System Validation (CSV)
  • System Development Life Cycle (SDLC) Methodology

Session 2 (90 Mins):

  • GAMP 5 Software Categorization
  • System Risk Assessment

Session 3 (90 Mins):

  • Requirements
  • Design
  • Testing
  • Requirements Traceability Matrix (RTM)
  • Additional Validation Documentation

Session 4 (90 Mins):

  • FDA Inspection Trends
  • Regulatory Influences
  • Response to Change

For more information about this webinar visit https://www.researchandmarkets.com/r/wa40ck


Laura Wood, Senior Press Manager
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Topics: Drug
, Pharmaceutical