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Seminar on

Validation and 21 CFR Part 11 Compliance of Computer Systems

Date & Time: May 03rd and May 04th 2012

9 AM PDT to 5 PM PDT

Duration: 2 Days

Instructor: Angela Bazigos

Location: San Francisco

Price : $1695.00

 

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(for one

participant)

Instructor Profile: Angela Bazigos CEO, Touchstone Technologies Silicon Valley

Overview: In December 2010 the FDA changed the way it does audits to include 21 CFR 11 add-on inspections. Very little is known about this, yet the FDA has already issued citations on the subject. This Webinar will

Angela Bazigos is the CEO of Touchstone Technologies Silicon Valley, Inc. an FDA Compliance company. She has almost 30 years experience in the Lifesciences industry and has applied for patents aimed at speeding up Software Compliance. She is a member of the SQA CVIC (Society of Quality Assurance Computer Validation Initiative Committee), DIA and RAPS and teaches classes on 21 CFR 11, Computer Systems Validation, Compliance Strategy and Project Management. More recently, Ms. Bazigos was selected to co-author Computerized Systems In Clinical Research / Current Data Quality and Data Integrity Concepts with FDA, DIA and Academia. ...more

present the latest on FDA thinking (with slides directly from the FDA's Office of Compliance), discuss how these inspections will impact both your company an the industry, and provide guidance on how your company can ensure that they have a successful inspection. Interactive course to cover all areas of 21 CFR 11 and how to include 21 CFR 11 requirements in computer systems validation. Will include exercises where the attendees will build all the deliverables for a computer system using the 21 CFR 11 principles and requirements. Finally, a fun ‘Jeopardy’ quiz will be used to test the participants’ knowledge

Areas Covered in the Session: Day 1, May 3rd, 2012 Lecture 1: Introduction to 21 CFR 11 l l l l l l l

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CFR CFR CFR CFR

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FDA’s Add-On Inspections for 21 CFR 11

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Lecture 2: 21 CFR 11.10 (a) Computer Systems Validation Deliverables l l l l l

Risk Assessment Vendor Audit Validation Plan Requirements Specification Design Specification

Day 2, May 4rd, 2012 Lecture 3: 21 CFR 11.10 (a) Computer Systems Validation Deliverables l l l l l l l l

Installation Qualification (IQ) Operational Qualification (OQ) Performance Qualification (PQ) Traceability Matrix Validation Summary Report Validation Registry SOPs 21 CFR 11 Audit

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Your Necessity is our Priority

11.10 (a)-(k) 11.30 11.50 11.70

21 CFR 11.100 21 CFR 11.200 21 CFR 11.300 The FDA’s Requirements for 21 CFR 11

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Suggest a Topic

History of 21 CFR 11 Current Status of 21 CFR 11 21 CFR 11 Overview


Lecture 4: 21 CFR 11.10 (A) Computer Systems Validation Deliverables Exercise l

Create ALL Deliverables for a Laboratory Information

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Management System (LIMS) Jeopardy - Test Your Knowledge

Click here to register for this webinar Who Will Benefit: l

Directors

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Managers

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Supervisors, and lead workers in Regulatory Affairs Quality Assurance and Quality Control

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Workers who will prepare GMP documents for early phase products as well as those who will review these documents

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Regulatory affairs workers who will need to deal with submissions covering early phase products.

It would be really nice if you can circulate this mail to all your deserving colleagues who can immensely benefit from this program. For more information, please contact the event coordinator. We look forward to seeing you at the webinar. Best regards, Event-coordinator GlobalCompliancePanel

About GlobalCompliancePanel GlobalCompliancePanel is an online knowledge fulfillment community portal & it has put together a new model for online compliance training by creating a single window of learning opportunities for compliance professionals & providing a forum for expert speakers/panelists to render their services through simplified online training delivery mechanisms. Our commitment is give compliance regulatory training, showcasing of best industry practices & quality enrichment training sessions in a most cost effective manner. Compliance professionals can benefit from a wide range of training sessions, giving a diverse choice of events & all sessions being either Live or recorded stream or in the form of audio CDs. GlobalCompliancePanel portal ensures a secure & cost effective online environment and also support your E-learning and development on/through our website. Keep track of all webinars arranged for your industry through notifications & event calendars being mailed to your inbox. GlobalCompliancePanel opens new doors of learning opportunities for professionals. GlobalCompliancePanel www.globalcompliancepanel.com 1000 N West Street Suite, 1200 Wilmington DE 19801 Phone: 800-447-9407 or Fax your PO to: 302-288-6884 If you do not wish to receive this training alerts from GlobalCompliancePanel Click Unsubscribe

Validation and 21 CFR Part 11 Compliance of Computer Systems - US Seminar 2012 at San Francisco  

In December 2010 the FDA changed the way it does audits to i...