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 manage 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 are 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
Learning Objectives:
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:
- What is Data Integrity and how is it implemented?
- How to use Risk Based Assessments to reduce work while still achieving Data Integrity and Compliance?
- Data Integrity Frequently Asked Questions
- Validation Master Plan
- Risk Based Assessment
- Complete Validation for a System (software development lifecycle)
- Automated Test Tools
- Infrastructure Requirements
- Change Control
- 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
- Registration Process: 8:30 AM – 9:00 AM
- 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
- 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
- SOPs
Angela Bazigos
CEO, Touchstone Technologies Silicon Valley
Angela Bazigos, is the CEO of Touchstone Technologies Silicon Valley, Inc. "Knowledge is Power". She has 35 years of experience in the Lifesciences industry spanning GLP, GCP, GMP, Medical Devices & 21 CFR 11 and has a patent aimed at speeding up Software Compliance.
Ms. Bazigos is a Past President of PRCSQA, a member of the SQA CVIC, ASQ, DIA and RAPS. She works closely with the FDA on behalf of her clients. She consults to LifeScience Investment Groups as well as to Pharma / Biotech / Medical Device companies on compliance matters, including strategy, submissions, quality assurance and remediations following action by the FDA.
More recently, Ms. Bazigos co-authored Computerized Systems in Clinical Research / Current Data Quality and Data Integrity Concepts with FDA, DIA and Academia. She was on the board for UC Berkeley’s Business School for Executive Education in Life Sciences and is now on the Stanford Who’s Who Registry for contributions to the Lifesciences industry.
Register Now
Online using Credit card
Get the Invitation
Pre-Register yourself and get the official Invite when venue and dates are announced for this seminar.
Call here to register +1-888-717-2436 or email at [email protected]
Other Registration Option
- Download the Order Form
- Fill this form with attendee details & payment details
- Fax it to +1-650-362-2367, or
- Email it to [email protected]
Payment Mode
ComplianceOnline (MetricStream, Inc),
6201 America Center Drive Suite 240
San Jose, CA 95002
USA
Register / Pay by Wire Transfer
Please contact us at +1-888-717-2436 to get details of wire transfer option.Terms & Conditions to Register for the Seminar/Conference/Event
Your registration for the seminar is subject to following terms and conditions. If you need any clarification before registering for this seminar please call us @ +1-888-717-2436 or email us @ [email protected]
Payment:
Payment is required 2 days before the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to MetricStream Inc. (our parent company).
Cancellations and substitutions:
Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund - less a $300 administration fee. No cancellations will be accepted - nor refunds issued - within 10 calendar days before the start date of the event.
On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($300) will be transferred to any future ComplianceOnline event and a credit note will be issued.
Substitutions may be made at any time. No-shows will be charged the full amount.
We discourage onsite registrations, however if you wish to register onsite, payment to happen through credit card immediately or check to be submitted onsite. Conference material will be given on the spot if it is available after distributing to other attendees. In case it is not available, we will send the material after the conference is over.
In the event ComplianceOnline cancels the seminar, ComplianceOnline is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.
Attendance confirmation and documents to carry to the seminar venue:
After we receive the payment from the registered attendee, an electronic event pass will be sent to the email address associated with the registrant 5 working days before the seminar date. Please bring the pass to the venue of the event.
Conference photograph / video:
By registering and attending ComplianceOnline conference, you agree to have your photographs or videos taken at the conference venue and you do not have any objections to ComplianceOnline using these photos and videos for marketing, archiving or any other conference related activities. You agree to release ComplianceOnline from any kind of claims arising out of copyright or privacy violations.
We are pleased to offer several exhibitor, sponsorship and media partnership options designed to maximize your company's exposure and networking opportunities before, during and after the event.
Benefits of becoming a Sponsor/Exhibitor/Media Partner:
- Logo on website, marketing email, branding materials & the registration booth
- Exhibit Space
- Free event pass
- Speaking opportunity
- Social media campaign
For more details and other sponsorship options at this event, please contact Event Manager: [email protected] or call: +1-650-238-9656
Media Partner:
Local Attractions of Sydney, Australia
Sydney Opera House
The Sydney Opera House is one of the most distinctive and famous 20th century buildings, and one of the most famous performing arts venues in the world. Though its name suggests a single venue, the project comprises multiple performance venues which together are among the busiest performing arts centers in the world — hosting over 1,500 performances each year attended by some 1.2 million people.
Sydney Harbour Bridge
The Sydney Harbour Bridge is one of Australia's most well known and photographed landmarks. It is the world's largest (but not the longest) steel arch bridge with the top of the bridge standing 134 metres above the harbour.
Bondi Beach
Sydney's most famous beach attracts large numbers of tourists to Bondi throughout the year with many Irish and British tourists spending Christmas Day there. Bondi Beach features many popular cafes, restaurants and hotels, some with spectacular views of the beach and surrounding headlands. The beach itself is approximately one kilometer long.
Darling Harbour
A lively harbourside precinct, Darling Harbour is just a 10-minute walk from Sydney city centre. One of Sydney's largest dining, shopping and entertainment precincts has a full calendar of outdoor events as well as one of the city's most restful spots, the Chinese Gardens of Friendship.
Taronga Zoo
Taronga Zoo is the nation's leading zoological garden, featuring Australia's finest collection of native animals and a diverse collection of exotic species. It is home to over 2,600 animals on 28.7 hectares, making it one of the largest of its kind, and it divided into eight zoogeographic regions with numerous indoor pavilions and outdoor exhibits.
The Rocks
The Rocks is an urban locality, tourist precinct and historic area of Sydney's city centre, in the state of New South Wales, Australia. It features a variety of souvenir and craft shops, and many themed and historic pubs. The Rocks Market operates each weekend, with around 100 stalls.
Sydney Tower
Sydney Tower is Sydney's tallest free-standing structure, and the second tallest in Australia (with the Q1 building on the Gold Coast being the tallest). The tower is open to the public, and is one of the most prominent tourist attractions in the city, being visible from a number of vantage points throughout town and from adjoining suburbs.
Museum of Contemporary Art
The Museum of Contemporary Art (abbreviated MCA) in Sydney, Australia is an Australian museum solely dedicated to exhibiting, interpreting and collecting contemporary art, both from across Australia and around the world. It is housed in the Art Deco-style former Maritime Services Board Building on the western edge of Circular Quay.
