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Seminar on Equipment, Facility, and Process Qualification and Validation - A Simple Top to Bottom Sustainable Approach - St. Petersburg, FL

Event Details

Seminar on Equipment, Facility, and Process Qualification and Validation - A Simple Top to Bottom Sustainable Approach - St. Petersburg, FL

Time: December 3, 2015 at 9am to December 4, 2015 at 6pm
Location: Courtyard St. Petersburg Downtown,300 4th St N, St Petersburg, FL 33701, United States
Street: 300 4th St N, St Petersburg, FL
City/Town: St Petersburg, FL
Website or Map: http://bit.ly/1PR53NH
Phone: 1-800-447-9407
Event Type: seminar
Organized By: NetZealous LLC - DBA GlobalCompliancePanel
Latest Activity: Nov 9, 2015

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Event Description

Course "Equipment, Facility, and Process Qualification and Validation - A Simple Top to Bottom Sustainable Approach" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

Overview:

Companies face many common issues and confusion when creating or revamping their validation programs. Some of these common issues are:

  • Company has expertise in its process validation program but can never quite get is arms around the facility and equipment changes that require never ending equipment qualification (IQ, OQ, PQ),
  • Customer or 483 audit findings require the company to deviate from its own validation program to meet the needs of the FDA or the customer
  • For systems that employ software and hardware, how does the company manage the validation activities (i.e. through the software validation effort or through the equipment qualification program? 


Well, the answers to these and many, many more typical questions are now available in this simple to understand, yet detailed training session designed to help manufacturers of FDA regulated products build (or rebuild) a sustainable validation program.

Why should you attend?

Attend this FDA validation seminar to get deep knowledge about:

  • How to define a Sustainable Structure of a Firm's Validation Program
  • Understand How Change Control and Other Quality Programs Feed Into the Validation Program
  • Offer Usable Protocol and Other Validation Program Document Templates
  • Define Minimal Recommended Tests and Verifications for
    • Equipment Qualification
    • Process Validation
    • Software Validation
  • Common Pitfalls to Avoid When Executing Validation Protocols
  • How to Estimate Costs and Time Associated with Validation
  • How to Respond to Customer and Regulatory Audit Observations Associated with Validation

Areas Covered in the Session:

  • Basics Of Validation
  • The Components of a Sustainable Validation Program
  • Other Programs that Feed the Validation Program (1 Hour)
  • Equipment, Utility, and Facility Qualification
  • Process Validation
  • Software Validation
  • Time and Costs of Validation
  • Responding to Validation and Other Related Audit Findings

Location: St. Petersburg, Florida Date: December 3rd & 4th, 2015 Time: 9 AM to 6 PM 

 

Venue: Courtyard St. Petersburg Downtown

Address: 300 4th St N, St Petersburg, Florida 33701, United States

 

Price: $1,295.00 (Seminar for One Delegate)

Register now and save $200.

Until November 15, Early Bird Price: $1,295.00

 

 From November 16 to December 01, Regular Price: $1,495.00

 

Registration Details:

NetZealous LLC - DBA GlobalCompliancePanel

161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA         

USA Phone: 1-800-447-9407

Fax: 302-288-6884

support@globalcompliancepanel.com  

http://www.globalcompliancepanel.com

Registration Link - http://bit.ly/1PR53NH

 

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