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Implementing 21 CFR Part 11 - What is Computer Systems Validation and how to Implement it. - By Compliance Global Inc.

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The webinar will cover the Computer Systems Validation Regulations and then cover how a company complies with those regulations when they implement a computer system. – PowerPoint PPT presentation

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Title: Implementing 21 CFR Part 11 - What is Computer Systems Validation and how to Implement it. - By Compliance Global Inc.


1
Toll Free 1-844-746-4244 support_at_complianceglob
al.us
Compliance Global Upcoming Webinar
  • .

.
Implementing 21 CFR Part 11 - What is Computer
Systems Validation and how to Implement it.
Speaker Richard Chamberlain Tuesday, July 07th
0100 PM EST
Compliance Global Inc 2015


www.ComplianceGlobal
.us
2
Upcoming Webinar of Richard
Chamberlain Implementing 21 CFR Part 11 - What
is Computer Systems Validation and how to
Implement it. Tuesday,
July 07th 0100 PM EST Overview The webinar
will cover the Computer Systems Validation
Regulations and then cover how a company complies
with those regulations when they implement a
computer system. Why Should You Attend The
requirements of FDA CFR Part 11 apply to the
implementation and use of computer systems that
are used to manage information that is to be
submitted to the Agency (FDA). By validating the
systems you are assuring that they are
functioning properly and are not posing a risk to
patients or others. When a submission is made to
FDA it is likely that the FDA will do an
inspection and they will review the process
validation documentation and procedures.
Compliance Global Inc 2015



www.ComplianceGlobal.us
3
  • Upcoming Webinar of Richard Chamberlain
  • Implementing 21 CFR Part 11 - What is Computer
    Systems Validation and how to Implement it.
  • Tuesday, July 07th
    0100 PM EST
  • Areas Covered in the webinar
  • This curse will cover the procedures that are to
    be followed and discuss all of the documentation
    that is to be prepared to meet the requirements
    of this regulation. Typically a System
    Development Life Cycle (SDLC) will be used to
    identify the Tasks to be performed, Those
    responsible for the tasks including those that
    are Responsible for the contents, the
    Deliverables that are to be produced that
    establish the Documented Evidence that the
    Computer System is working as intended.
  • Learning Objective
  • Be able to develop a Validation Plan
  • Contribute to the development of Specifications
  • Follow Programming Standards, if programming
  • Build and execute Test cases
  • Install and operate the Systems

Compliance Global Inc 2015



www.ComplianceGlobal.us
4
  • Upcoming Webinar of Richard Chamberlain
  • Implementing 21 CFR Part 11 - What is Computer
    Systems Validation and how to Implement it.
  • Tuesday, July 07th
    0100 PM EST
  • Who Will Benefit
  • IT Staff implementing and supporting these
    computer systems
  • Users of the computer systems
  • Quality Assurance Staff faced with auditing
    computer systems
  • Vendors of these Regulated computer systems

Compliance Global Inc 2015



www.ComplianceGlobal.us
5
Upcoming Webinar of Richard
Chamberlain Implementing 21 CFR Part 11 - What
is Computer Systems Validation and how to
Implement it. Tuesday,
July 07th 0100 PM EST Level Intermediate
Speaker profile Richard Chamberlain is the
President, Executive Consultant Services, LLC
Consulting with numerous Pharmaceutical, Contract
Research Organizations, and Medical Device
companies in the areas of computerized project
scheduling, strategic planning and Computer
Systems Validation. View More
Compliance Global Inc 2015



www.ComplianceGlobal.us
6
  • Webinars
  • Seminars
  • Consulting

For more information...www.ComplianceGlobal.us
Or contact us at Toll Free 1-844-746-4244
Tel1-516-900-5515Fax 1-516-900-5510 Email
support_at_complianceglobal.us
Compliance Global Inc 2015



www.ComplianceGlobal.us
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