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How to Buy COTS Software, Audit Vendors and Validate the Software

Tuesday, Mar 28, 2017 at 11:30AM - 2:30PM

Online Event

  • Mar 2017

    28 Tue

    11:30AM

  • Mar 2017

    28 Tue

    2:30PM

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How to Buy COTS Software, Audit Vendors and Validate the Software

Tuesday, Mar 28, 2017 at 11:30AM - 2:30PM

Fremont

No tickets available

Description
This presentation will focus on instructing attendees on best practices for buying COTS (Commercial Off-The-Shelf) software and evaluating software vendor(s). Presentation will highlight essential data and systems subject to Part 11 & Annex 11 (ERES - Electronic Records and Electronic Signatures) compliance while listing requirements for IT infrastructure, Laboratories, Manufacturing/ Operations, R&D, Regulatory and other GxP relevant areas of an FDA regulated manufacturer. By taking the course, Developing / Start-up companies will have an edge in avoiding costly mistakes due to misunderstanding and omissions, common for a company in its infancy. For the emerging / existing and companies experiencing 483's, Consent Decree, CAPA's, Remediation; meaningful insight will be provided to quickly and efficiently bring compliance to computerize/software systems.

Objectives Of The Presentation
  • Project Charter
  • Vendor Audits
  • Validation Master Plan
  • Requirements Documents
  • Risk Assessment / Management
  • IQ, OQ, PQ Validation Plan
  • Protocols / Procedures
  • GAMP 5 Standards
  • 21 CFR Part 11 & Annex 11 Regulations
  • Associated / Relevant documents
  • Avoidance of 483's / Warning Letters
Why Should you Attend
This webinar will provide the process steps to:
  • Buy Commercial Off-The-Shelf (COTS) software
  • Evaluate / Vetting / Audit of software vendors
  • Validate for 21 CFR Part 11 / Annex 11
Presentation will detail the SOPs, product features and developer validation & specifications documentation requirements for auditing software vendors. Attendees will learn how to efficiently validate COTS software and understand how to use change control for currently validated systems.

Areas Covered
  • How to buy COTS software
    • Product features to look for when purchasing COTS software
    • How to evaluate a software vendor
    • Which data and systems are subject to ERES
  • Learn the requirements for IT Infrastructure / CSV Compliance
  • Understand the current computer system industry standards for security, data transfer, end-to-end testing, data integrity, audit trails and electronic signatures
  • SOPs required per GAMP 5 standards and ERES regulations
  • Avoid 483 and Warning Letters
Who will Benefit
  • Computer system Users, SME's, Technical Owners and Business Owners
  • IT Developers, Business Admins, Implementation Specialists
  • IT department
  • QC, QA, QE
  • Managers and executives
  • Training Department
  • Regulatory Affairs
  • Production / Manufacturing and lab managers
  • Documentation department & Consultants.


For Registration

http://onlinecompliancepanel.com/webinar/COTS-SOFTWARE-AUDIT-VENDORS-505707/MARCH-2017-ES-EZEVENT


Note: Use Promo code PTY2D and get 10% off on registration (Valid till MARCH 31st 2017)

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