2-day In-person Seminar on “Validation and 21 CFR Part 11 Compliance of Computer Systems” at Singapore

This Interactive course to cover all areas of 21 CFR 11 and how to include 21 CFR 11 requirements in computer systems validation.

Medical & Health Care, Pharmaceuticals/Drug Discovery

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This 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

Why should you attend:
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 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 and the industry, and provide guidance on how your company can ensure that they have a successful inspection.

Who will benefit:
• Everybody using computers in FDA or regulated environments
• IT manager and staff
• QA managers and personnel
• Regulatory affairs
• Training departments
• Consultants
• Validation specialists
• Project Managers
• Vendors of COTS (Commercial Off The Shelf) systems in regulated industries
• Anyone dealing with electronic records and/or electronic signatures
Course Outline/Agenda:
Day One:
Lecture 1: Introduction to 21 CFR 11
1. History of 21 CFR 11
2. Current Status of 21 CFR 11
3. 21 CFR 11 Overview
4. 21 CFR 11.10 (a)-(k)
5. 21 CFR 11.30
6. 21 CFR 11.50
7. 21 CFR 11.70
8. 21 CFR 11.100
9. 21 CFR 11.200
10. 21 CFR 11.300
11. The FDA's Requirements for 21 CFR 11
12. FDA's Add-On Inspections for 21 CFR 11
Lecture 2: 21 CFR 11.10 (A) Computer Systems Validation Deliverables
1. Risk Assessment
2. Vendor Audit
3. Validation Plan
4. Requirements Specification
5. Design Specification

Day Two:
Lecture 3: 21 CFR 11.10 (A) Computer Systems Validation Deliverables
1. Installation Qualification (IQ)
2. Operational Qualification (OQ)
3. Performance Qualification (PQ)
4. Traceability Matrix
5. Validation Summary Report
6. Validation Registry
7. SOPs
8. 21 CFR 11 Audit

Lecture 4: 21 CFR 11.10 (A) Computer Systems Validation Deliverables Exercise
1. Create ALL Deliverables for a Laboratory Information Management System (LIMS)
2. Jeopardy - Test Your Knowledge

Instructor/Speaker Profile:
Angela Bazigos, is the CEO of Touchstone Technologies Silicon Valley, Inc. "Your Passport to Compliance". She has 30 years of experience in the Life sciences industry spanning Project Management, Quality Assurance and Regulatory Affairs and has a patent aimed at speeding up Software Compliance.

Ms Bazigos is a member of the SQA CVIC (Society of Quality Assurance Computer Validation Initiative Committee), ASQ, DIA and RAPS and consults to investment groups on Life sciences investments as well as Pharma / Biotech / Medical Device companies on compliance matters, including strategy, submissions, quality assurance and remediation’s following action by the FDA. She teaches classes on Compliance, 21 CFR 11, Computer Systems Validation, and Project Management both to investor groups and industry.

More recently, Ms. Bazigos co-authored Computerized Systems in Clinical Research / Current Data Quality and Data Integrity Concepts with FDA, DIA and Academia. She is on the board for UC Berkeley's Business School for Executive Education in Life Sciences and on the Stanford Who's Who Registry for contributions to the Life science industry.

Date, Venue and Price:
Location: Boston, MA
Date: 7th and 8t April 2014
Venue: Mandarin Orchard Singapore
Address: 333 Orchard Road, Singapore 238867
Price: $1595.00
Discount for One Delegate and Group Participants:
Register now and save $200. (Early Bird)
Until March 10, Early Bird Price: $1,595.00
From March 11 to April 5, Regular Price: $1,795.00

Contact Information:
Event Coordinator
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Email: support@globalcompliancepanel.com
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