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    FDA DATA INTEGRITY FOR COMPUTERIZED SYSTEMS IN MUM 2017 - Seminar on FDA Data Integrity for Computerized Systems in Mumbai

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    Website https://www.globalcompliancepanel.in/control/FDA-data-integrity-21-CFR-11-Mumbai?channel=mailer&camp | Want to Edit it Edit Freely

    Category FDA;Online Regulatory Compliance Training;FDA Regulations Training;Compliance Seminars

    Deadline: April 25, 2017 | Date: April 27, 2017-April 28, 2017

    Venue/Country: The LaLiT Mumbai Address: Sahar Airport Road, Andh, India

    Updated: 2017-02-17 15:08:38 (GMT+9)

    Call For Papers - CFP

    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: Mumbai, India Date: April 27th & 28th, 2017 and Time: 9:00 AM to 6:00 PM

    Venue: The LaLiT Mumbai

    Address: Sahar Airport Road, Andheri East, Mumbai - 400059

    Price:

    Register now and save ₹ 2000. (Early Bird)

    Price: ₹ 14,000 (Seminar for one Delegate)

    Until March 25, Early Bird Price: 14,000 From March 26 to April 25, Regular Price: 16,000

    Registration Details:

    NetZealous - GlobalCompliancePanel

    NetZealous Services India Pvt. Ltd.

    Gururaya Mansion, 759 to 764, 8th Main road, J.P.Nagar,

    Bangalore - 560078 Karnataka, INDIA

    Phone: 1800 425 9409

    Fax: 080-25149544

    smanzooratnetzealous.com

    http://www.globalcompliancepanel.in/

    Registration Link – https://www.globalcompliancepanel.in/control/FDA-data-integrity-21-CFR-11-Mumbai

    Follow us on LinkedIn: https://www.linkedin.com/company/globalcompliancepanelindia


    Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
    Disclaimer: ourGlocal is an open academical resource system, which anyone can edit or update. Usually, journal information updated by us, journal managers or others. So the information is old or wrong now. Specially, impact factor is changing every year. Even it was correct when updated, it may have been changed now. So please go to Thomson Reuters to confirm latest value about Journal impact factor.