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Event Contacts

Event Manager
161 Mission Falls Lane, Suite 216
Fremont, CA 94539
(800) 447-9407

Event Description

Excel® Applications are widely used in laboratories, offices and manufacturing e.g., for data capture, data manipulation and report generation. Regulations such as FDA's GxPs and 21 CFR Part 11 require users of software and computer systems to demonstrate and document data accuracy, integrity and confidentiality.

Areas Covered in the Session:
    FDA and other agency's requirements for spreadsheet validation - What do inspectors ask and what documents should be available.
    Learning from FDA warning letters related to spreadsheets
    How to design spreadsheets for Part 11/GxP/Annex 11 compliance
    Validation during design, development, installation and on-going use
    When, what and how much to test?

For Easy Implementation, Attendees Will Receive
    User Manual with Excel functions that help to comply with FDA requirements
    SOP: Validation of spreadsheet applications
    SOP: Development and use of spreadsheets in regulated environments
    Gap analysis/checklist for Macros and Spreadsheet applications

Who Will Benefit:
    Pharmaceutical and medical device industry
    Contract laboratories
    All developers and users of spreadsheet applications
    Validation specialists

Speaker Profile:
Dr. Ludwig Huber Ph.D., is the director and editor of Labcompliance the global online resource for validation and compliance. He is the author of the books "Validation and Qualification in Analytical Laboratories" and "Validation of Computerized Analytical and Networked Systems, Informa Healthcare".

Contact Detail:

Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Event Link :
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There may be many networking opportunities at the Webinar on Spreadsheets in FDA Regulated Environments. Find out more in the event details below.

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Event Details

Conference/Event Dates: 01/04/2017 - 01/04/2017
Conference/Event Hours: 75 Minutes
Classification: B2B
Primary Industry: Business Technology
Other Industries: Business Technology, Technology
Cost to Attend: One Dial-in One Attendee Price: $150.00
Audience: Pharmaceutical and medical device industry
Contract laboratories
All developers and users of spreadsheet applications
Validation specialists
Number of Exhibitors:1

Booth Details

Booth Size Booth Cost   Available Amenities
No Exhibiting   Electricity: n/a
  Water: n/a
  Generator: n/a
  Marketing Vehicles Allowed: n/a
Other Booth Sizes Available: n/a

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