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Conference

Best Practices in Preparation for an FDA Computer System Audit

27 Aug 2020

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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 specific rules. This webinar will help you understand the FDA’s current thinking on computer systems that are validated and subject to inspection and audit. It will also consider areas where FDA will likely focus their effort, including on the higher-risk systems. It will cover areas that will help you to plan for an on-site inspection.

Highlights

  • Learn Computer System Validation (CSV) and the System Development Life Cycle (SDLC) Methodology
  • Learn “GxP” – Good Manufacturing, Laboratory and Clinical Practices
  • Understand data Archival to ensure security, integrity and compliance

Timings

Starts at 10:00 AM GMT-07:00

Entry Fees

Paid Ticket Starts from 249 USD View Details

Participants

upto 100
Delegates
Estimated Count

Category & Type

Conference
IT & Technology

Editions

27 Aug 2020 Interested


Frequency Annual

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Organizer

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ComplianceOnline Top Rated

USA 535 Total Events / 60 Upcoming Events 72+ Followers

Schedule & Agenda

Thu, 27 Aug
Session
Best Practices in Preparation for an FDA Computer System Audit

Speakers

Speaker
Carolyn Troiano

Carolyn Troiano

ERP Project Manager, City of Richmond

Visitor Ticket Price Buy Now

249 USDOne Dial-in One Attendee

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