21 CFR Part 11 Compliance for SaaS/Cloud Applications training seminars presented by ComplianceOnline register now on FindaSeminar.com

findaseminar logo balls FindaSeminar.com
event search registration and marketing services since 2002
Advanced Search
 
 

21 CFR Part 11 Compliance for SaaS/Cloud Applications  

 Email information about this seminar 21 CFR Part 11 Compliance for SaaS/Cloud Applications by ComplianceOnline to yourself your manager or associates Email this event... View and register for other training seminars like 21 CFR Part 11 Compliance for SaaS/Cloud Applications by ComplianceOnline on FindaSeminar.com Find similar training.. Find and register for other training seminars by ComplianceOnline on FindaSeminar.com Other seminars from ComplianceOnline

By:

training seminars by ComplianceOnline ComplianceOnline   

For:

Regulatory Affairs, QA/ QCIT/IS, Software Managers, Project Managers, Software vendors and suppliers

Cost:   

see Registration info for seminar cost, group discount etc.

Seminar Summary:

The instructor will address the latest computer system industry standards for data security,data transfer,computer system validation related to FDA 21 CFR Part 11, European Annex 11, and HIPAA electronic security regulations for patient medical records. (see full course description)

 

 Seminar / Training class dates & locations

 

No seminar dates for this event are currently scheduled.  Please use the seminars search box above or choose one of the following additional training search options to find similar training.

21+CFR+Part+11+SaaS+Cloud+Applications+Compliance training seminars workshops conferences online training

Providers course catalog

Find seminars by state

Find seminars by city

Request on site training

Use Advanced Search

NEW  Don't miss training you want to attend

Receive a personal Training Alert when training you want to attend comes to your area. Create a personal Training Alert now  it's Free and only takes a minute!


 

 

 

share this page 

print the agenda print agenda for the 21 CFR Part 11 Compliance for SaaS/Cloud Applications seminar

 

 

Training Course Syllabus:


This interactive two-day course will explore proven techniques for reducing costs associated with implementing, using, and maintaining computer systems in regulated environments. Today, the FDA performs both GxP and Part 11 inspections, the Europeans have released an updated Annex 11 regulation that expands Part 11 requirements and companies must update their systems and processes to maintain compliance.

Many companies outsource IT resources and are involved in Software as a Service (SaaS) and cloud computing. These vendors are not regulated, and therefore, regulated companies must ensure compliance for both infrastructure qualification and computer system validation to avoid FDA form 483s and Warning Letters.

This course is intended for these regulated companies, software vendors, and SaaS/cloud providers. The seminar instructor will:

  • Address the latest computer system industry standards for data security,data transfer, audit trails, electronic records and signatures, software validation, and computer system validation.
  • Help participants understand the specific requirements associated with local and SaaS/cloud hosting solutions.
  • Illustrate the importance of validating the quality process and every computerized system used in laboratory, clinical, and manufacturing settings.
  • Demonstrate how to decrease software implementation times and lower costs using a 10-step risk-based approach to computer system validation.
  • Review recent FDA inspection trends and discuss how to streamline document authoring, revision, review, and approval.

Learning Objective:
  • Understand what is expected in Part 11 and Annex 11 inspections
  • Avoid 483s and Warning Letters
  • Learn how to buy COTS software and qualify vendors
  • Implement a computer system using risk-based validation to gain maximum productivity and reduce cost by as much as two thirds
  • Requirements for local, SaaS, and cloud hosting
  • How to select resources and manage validation projects
  • "Right size" change control methods that allows quick and safe system evolution
  • Minimize the validation documentation to reduce costs without increasing regulatory or business risk
  • Write test cases that trace to elements of risk management
  • Protect intellectual property and keep electronic records safe

Course Outline:

Day One (8:30 AM – 4:30 PM)


Registration Process: 8:30 AM – 9:00 AM

Session Start Time: 9:00 AM

  • Introduction to the FDA (1 hr)
    • How the regulations help your company to be successful
    • Which data and systems are subject to Part 11.
  • 21 CFR Part 11 - Compliance for Electronic Records and Signatures (4 hr)
    • What Part 11 means to you, not just what it says in the regulation.
    • Avoid 483 and Warning Letters.
    • Explore the three primary areas of Part 11 compliance: SOPs, software product features, and validation documentation.
    • How SaaS/cloud computing changes qualification and validation
    • Ensure data integrity, security, and protect intellectual property.
    • Understand the current computer system industry standards for security, data transfer, and audit trails.
    • Electronic signatures, digital pens, and biometric signatures.
    • SOPs required for the IT infrastructure.
    • Product features to look for when purchasing COTS software.
    • Reduce validation resources by using easy to understand fill-in-the-blank validation documents.
  • HIPAA Compliance for Electronic Records (30 Min)
    • How Part 11 and HIPAA interrelate
    • What are the additional requirements for patient data
  • The Five Keys to COTS Computer System Validation (30 Min)
    • The Who, What, Where, When, and Why of CSV
  • The Validation Team (30 Min)
    • How to select team members
    • How to facilitate a validation project
  • Day Two (8:30 AM – 4:30 PM)

  • Ten-Step Process for COTS Risk-Based Computer System Validation (1 hr)
    • Learn which documents the FDA expects to audit.
    • How to use the risk-based validation approach to lower costs.
    • How to link requirements, specifications, risk management, and testing.
    • Document a computer system validation project using easy to understand fill-in-the-blank templates.
    • Based on: "Risk-Based Software Validation - Ten Easy Steps" (Davis Horwood International and PDA - www.pda.org, 2006).
  • How to Write Requirements and Specifications (30 Min)
    • Workshop for writing requirements and then expanding them for specifications
  • How to Conduct a Hazard Analysis/Risk Assessment-Exercise (30 Min)
    • Step-by-step instructions for performing and documenting a risk assessment, and how to use the results to reduce validation documentation.
  • Software Testing (1 hr)
    • Reduce testing by writing test cases that trace to elements of risk management.
    • How to write efficient test cases
  • System Change Control (30 Min)
    • How to manage a validated system with minimal documentation
  • Purchasing COTS Software (30 Min)
    • How to purchase COTS software and evaluate software vendors
  • Cost Reduction Without Increasing Regulatory or Business Risk (1 hr)
    • How to save money
    • How to increase quality
    • How to increase compliance with less documentation
  • Seminar Summary:

    The instructor will address the latest computer system industry standards for data security,data transfer,computer system validation related to FDA 21 CFR Part 11, European Annex 11, and HIPAA electronic security regulations for patient medical records. (see full course description)

    print this agenda print agenda for the 21 CFR Part 11 Compliance for SaaS/Cloud Applications training seminar

     view dates and locations for this seminar

     

     

     

    Custom Search