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FDA Data Integrity for Computerized Systems - seminar at Singapore

Monday, Apr 24, 2017 at 9:00AM - Tuesday, Apr 25, 2017 at 6:00PM

Mandarin Orchard Singapore

  • Apr 2017

    24 Mon

    9:00AM

  • Apr 2017

    25 Tue

    6:00PM

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FDA Data Integrity for Computerized Systems - seminar at Singapore

Monday, Apr 24, 2017 at 9:00AM - Tuesday, Apr 25, 2017 at 6:00PM

Singapore

No tickets available

Overview:

The Problem:

We have all heard of Data
Integrity but do you really understand what it is? Do you understand how 21 CFR
11 and Annex 11 fit into this picture? Specifically, can you answer questions on
the following?

  • Evolution of 21 CFR Part
    11 and Annex 11 and Why they are Back in the News
  • Overview and Key
    Requirements of Part 11 & Annex 11
  • How to use a Risk Based
    Assessment to reduce work while still achieving Data Integrity and
    Compliance?
  • How FDA & other
    Regulatory Authorities Inspect Computerized Systems for Data Integrity?

I often refer to 21 CFR 11 and
Annex 11 as Good Software Engineering with the Documentation on Steroids!
However, unless one knows how to implement Data Integrity, it is often very
hard to apply requirements for DATA INTEGRITY to computerized system, and very
hard to determine what needs to be done, to meet domestic and / or
international regulations or business continuity requirements. In addition, the
agencies have stepped up data integrity inspections and the number of citations
on the subject is skyrocketing!

This course is appropriate for
beginner and experienced person alike. The topics will build on each other and
will give you the latest trends in our heavily regulated industry and how to
make it easy for yourself while still achieving data integrity.

This is a very hands-on class and
the attendees will be given take away templates that will enable them to build
a complete package to meet Data Integrity Requirements for Computerized Systems

The Seminar:

This Hands-On course will provide
the attendees with more detailed experience on validation / 21 CFR 11
compliance of a computer system, as well as details for activities associated
with computer systems validation as follows:

  1. What is Data Integrity
    and how is it implemented
  2. How to use Risk Based
    Assessments to reduce work while still achieving Data Integrity and
    Compliance?
  3. Data Integrity
    Frequently Asked Questions
  4. Validation Master Plan
  5. Risk Based Assessment
  6. Complete Validation for
    a System (software development lifecycle)
  7. Automated Test Tools
  8. Infrastructure
    Requirements
  9. Change Control
  10. SOPs

Who will benefit:

  • VP of IT
  • Director of IT
  • Quality Managers
  • Project Managers (for
    DATA INTEGRITY / IT)
  • Validation Specialists
  • Database Administrators
  • System Administrators
  • Directors / Senior
    Directors of Discovery
  • Directors / Senior
    Directors of Development
  • Directors / Senior
    Directors of Commercialization
  • Document Managers
  • Training Managers
  • Consultants
  • Data Managers
  • Safety Managers

Agenda:

Day 1 Schedule

Day 1 Schedule

Lecture 1:

Introduction / Background

  • Introductions /
    Participants' Understanding
  • Participants' Objectives
    for the Course (Please come prepared to discuss)

Lecture 2:

Data Integrity

  • What is Data Integrity
  • How is it implemented
  • Data Integrity
    Frequently Asked Questions

Lecture 3:

21 CFR 11 & Annex 11

  • 21 CFR 11
  • Annex 11
  • 21 CFR 11.10(a) -
    Computer Systems Validation

Lecture 4:

Risk Assessment & Requirements

  • Risk Assessment for
    Requirements
  • Gathering Requirements
  • Entity Relationship
    Diagram
  • Process Decomposition
  • Exercise on how to
    create Requirements
  • SOPs

Day 2 Schedule

Lecture 1:

Design

  • Design Specifications
  • Software Configuration
    and Build
  • Exercise on how to
    create Design Specifications

Lecture 2:

Verification & Testing

  • Traceability Matrix
  • Verification and Testing
  • Other Documents

Lecture 3:

Special Topics

  • Test Tools for DATA
    INTEGRITY
  • Infrastructure
    Requirements

Lecture 4:

Change Control & SOPs

  • Change Control

Speaker:

Angela
Bazigos

CEO, Touchstone Technologies Silicon Valley

Angela Bazigos, is
the CEO of Touchstone Technologies Silicon Valley, Inc. "Your Passport to
Compliance". She has 30 years of experience in the Lifesciences 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 Lifesciences investments as well as Pharma
/ Biotech / Medical Device companies on compliance matters, including strategy,
submissions, quality assurance and remediations 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 Lifescience industry.

Location: Singapore Date:April 24th & 25th, 2017 and
Time: 9:00
AM to 6:00 PM

 

Venue: Mandarin
Orchard Singapore

Address: 333 Orchard
Road, Singapore 238867

Tel: (65) 6235 7788

 

Price:

 

Price: $1,695.00 (Seminar Fee for One Delegate)

 

Register for 5 attendees Price: $5085.00 $8,475.00
You Save: $3390.00 (40%)*

 

Until March 10, Early Bird Price: $1,695.00 from March
11 to April 22, Regular Price: $1,895.00

 

Quick Contact:

NetZealous DBA as
GlobalCompliancePanel

 

Phone: 1-800-447-9407

Fax: 302-288-6884

Email: support@globalcompliancepanel.com               

Website: http://www.globalcompliancepanel.com

Registration Link - http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900946SEMINAR?channel=mailer&camp=seminar&AdGroup=ezevent_april_2017_SEO

Follow on LinkedIn: https://www.linkedin.com/company/globalcompliancepanel

 

 

 

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