Data Governance and Computer System Validation (CSV) Compliance

Event Information
Product Format
Prerecorded Event
Presenter(s)
Conference Date
Tue, Jun 19, 2018
Length
90 minutes
Product Description

Ensure FDA Compliance with Good Data Governance


Complying with U.S. Food and Drug Administration (FDA) rules for GxP systems is neither easy nor cheap, but there are strategies and proven best practices than can smooth the process and help ensure that your data are governed with integrity and costs are minimized. The only hitch is you need a pro on your side to make sure your system is robust.

Join computer system validation (CSV) pro Carolyn Troiano in this live webinar as she walks you through both the CSV and system development life cycle methodologies. You need solid maintenance for your data governance systems, and Troiano is one of the best in the business at showing you the best ways to attain the level of compliance you need.

After attending this audio event you will know about good variable practices (GxP), good manufacturing practices, good laboratory practice, and good clinical practices, plus data archival standards aimed at ensuring integrity, security, and compliance. Don’t try and meet FDA’s GxP regs without help—CSVs are critical if you want to work with the agency.

Session Highlights

Here is a taste of what you will uncover:

  • Computer system validation (CSV) and system development life cycle methodology
  • Good “variable” practices (GxP), including good manufacturing practices, good lab practices, and good clinical practices
  • Data governance models and practices
  • Validation planning which takes into account the system risk assessment process and GAMP 5 system categorization
  • Data archival and governance to ensure security, integrity, and compliance
  • Good documentation practices

Who Should Attend

  • Information technology analysts
  • QC/QA managers and analysts
  • Clinical data managers and scientists
  • Compliance managers
  • Lab managers
  • Automation analysts
  • CSV specialists
  • CMP training specialists
  • Business stakeholders responsible for CSV planning, execution, reporting, compliance, maintenance, and auditing
  • Consultants working in the life sciences industry who are involved in CSV implementation, validation, and compliance
  • Auditors engaged in internal inspections or labeling records and practices
  • All FDA-regulated industries, including life sciences, pharmaceuticals, biotechnology, medical devices, and tobacco and related industries such as cigars and e-cigs

Ask a question at the Q&A session following the live event and get advice unique to your situation, directly from our expert speaker.

Order Below or Call 1-866-458-2965 Today

You can also order through:
Phone

1-866-458-2965

Fax

1-919-287-2643

About Our Speaker

Carolyn Troiano - FDA Regulation Expert

Carolyn Troiano has more than 35 years of experience in the tobacco, pharmaceutical, medical device and other FDA-regulated industries. She has worked directly, or on a consulting basis, for many of the larger pharmaceutical and tobacco companies in the US and Europe, developing and executing compliance strategies and programs.


Carolyn has spent a number of years evaluating supply chain security and compliance, including technologies...   More Info
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