2-day In-person Seminar on “Validate your own Excel Spreadsheet Application” at San Francisco

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Description

In this two-day seminar, you will learn how to configure your Excel application with the features required for 21 CFR part 11 compliance, helping you to avoid 483s. Using the risk-based computer system validation approach, you will validate your own Excel application. Use of the validation templates is necessary and important because it typically saves two-thirds of the validation time and costs. This seminar will improve your Excel skills and create a set of validation documents that you can use for subsequent Excel application validation projects.

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							2-day In-person Seminar on “Validate your own Excel
Spreadsheet Application” at San Francisco
By David Nettleton



Course "Validate your own Excel Spreadsheet Application" has been pre-approved by RAPS as
eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

Overview:

In this two-day seminar, you will learn how to configure your Excel application with the features
required for 21 CFR part 11 compliance, helping you to avoid 483s. Using the risk-based computer
system validation approach, you will validate your own Excel application. Use of the validation
templates is necessary and important because it typically saves two-thirds of the validation time and
costs. This seminar will improve your Excel skills and create a set of validation documents that you
can use for subsequent Excel application validation projects.

Who Will Benefit:

Executives/Managers within Dietary Supplement or Natural Product companies

Regulatory Compliance Professionals in the Supplements or Natural Products area

Quality Assurance or Quality Control Professionals

Dietary Supplement or Natural Product Manufacturers & Distributors

Sales/Marketing Personnel in the Supplement or Natural Product Industries
Day 1 - 21st February 2013

Lecture 1: Introductions

Lecture 2: Regulations for Electronic Records

Lecture 3: 21 CFR Part 11 - Electronic Records & Signatures

Lecture 4: The Risk-Based Validation Approach

Lecture 5: Excel Applications - part 1

Day 2 - 22nd February 2013

Lecture 6: How to Conduct a Hazard Analysis/Risk Assessment
Lecture 7: Excel Applications - part 2
Lecture 8: Main Concepts to Remember
Lecture 9: &A


ABOUUT SPEAKER –
David Nettleton is an FDA Compliance Specialist for 21 CFR Part 11, HIPAA, and Computer System
Validation. His latest book is Risk Based Software Validation - Ten easy Steps. It relates to the development,
purchase, installation, operation and maintenance of computerized systems used in regulated applications.

He specializes in performing gap analysis, remediation plans, SOP development, vendor audits, training, and
project management. He has completed more than 225 mission critical software validation projects.

Location : San Francisco | February 21st & 22nd, 2013 (Thursday & Friday)
Location : Washington DC | June 27th & 28th, 2013 (Thursday & Friday)
HOTEL - WILL BE ANNOUNCED SOON

Contact Information:
GlobalCompliancePanel
Event Coordinator

Toll free: 800-425-9409

Fax: 302-288-6884

http://www.globalcompliancepanel.com

Email: support@globalcompliancepanel.com

Price: $1,295.00

GlobalCompliancePanel,
USA, Livermore Common, Fremont,
CA 94539, USA Phone: 1800 425 9407