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6th Edition  Conference

21 CFR Part 11 Compliance for SaaS/Cloud Applications


This highly interactive two-day course uses real life examples and explores proven techniques for reducing costs, usually by two-thirds, associated with implementing, and maintaining computer systems in regulated environments. Learn how to use electronic records and electronic signatures to maximize productivity, Understand what is expected in Part 11 and Annex 11 inspections so you are prepared, Avoid 483 and Warning Letters, Learn how HIPAA expands Part 11 compliance, Learn how to buy COTS software and qualify vendors


Highlights

  • 21 CFR Part 11 - Compliance for Electronic Records and Signatures
  • HIPAA Compliance for Electronic Records, The Five Keys to COTS Computer System Validation
  • The Validation Team, Ten-Step Process for COTS Risk-Based Computer System Validation
  • How to Write Requirements and Specifications, Software Testing, Purchasing COTS Software
  • How to Conduct a Hazard Analysis/Risk Assessment-Exercise, How to write a Data Privacy Statement

Timings

8:00 AM - 5:00 PM (Jun 13) (General)
8:00 AM - 3:30 PM (Jun 14) (General)

Entry Fees

Paid Ticket Starts from 1499 USD View Details

Participants

20
Delegates

5 Exhibitors Estimated Count

Category & Type

Conference
Medical & Pharma
IT & Technology

Editions

26-27 Sep 2019 6th Edition
14-15 Sep 2017 5th Edition
08-09 May 2017 4th Edition
08-09 Sep 2016 3rd Edition
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Frequency Bi-annual
Next edition likely in Mar 2020 Interested

Official Links

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ComplianceOnline USA

Top Rated 351 events listed

User Community [ Users who have shown interest for this Event ]

Sridevi

Sridevi

Technical delivery manager at Suvoda

Philadelphia, United States
Meng-Ting

Meng-Ting

Student at MSU

San Diego, United States
Valez Berisha

Valez Berisha

Software Developer at bevuta IT GmbH

Nesher, Israel
Rotimi Fabuluje

Rotimi Fabuluje

M.D. at Self Employed (ICT)

Ibadan, Nigeria
Toyin Folarin

Toyin Folarin

Managing Director at PLODNY INTEGRATED SERVICESLTD

Lagos, Nigeria
Charles Emenugha

Charles Emenugha

MIS Database Administrator and Technology Lead, Mobiles for Quality Improvement (M4QI) at Marie Stopes International

Abuja, Nigeria
Stanley Romio

Stanley Romio

Director General at Elim Link

Lagos, Nigeria

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Visitor Ticket Price

1499 USDAttendee Seminar One Registration
39.953000 -75.165000

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Venue to be announced

Philadelphia, USA

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