The FDA and other Health Authorities worldwide have focused their attention on data integrity. The intent of Computer System Validation (CSV) is to ensure that computerized systems are developed and configured such that data integrity risk is reduced to an acceptable level. In today’s world, a company’s computerized systems may exist as cloud-based services. Such Software-as-a-Service (SaaS) models are hosted remotely and can be quite complex. Unfortunately, many of the companies that the instructor has audited have commercial off-the-shelf systems in place that show evidence of numerous data integrity issues. These issues are the result of either deliberate or inadvertent inadequate configuration and validation. Often SaaS providers are unaware of the regulatory requirements of their customers.

This Computer System Validation Training course is intended to be an introduction to the terminology and documentation requirements and the regulatory basis of CSV in the regulated Life Sciences industries. Although many companies outsource their Information Technology support or rely on cloud-based services, ultimately, compliance responsibility falls solely upon the Life Sciences company. This responsibility also extends to those US companies sourcing their supplies from foreign manufacturers or conducting clinical trials in other countries. As such, it is in the best interest of those responsible for computerized systems to understand the regulatory basis, documentation, testing and controls required to meet regulatory expectations and avoid regulatory action from Health Authorities.

Seminar Fee Includes:
AM-PM Tea/Coffee
Seminar Material
USB with seminar presentation
Hard copy of presentation
Attendance Certificate
$100 Gift Cert for next seminar

Topics covered in this seminar include the concepts of Part 11 compliance, data integrity and risk management, quality management systems associated with CSV, privacy issues, testing and documentation, and the software life cycle. Techniques for conducting internal audits of computerized system will also be discussed. Several sessions will be conducted as interactive exercises.

This Computer System Validation Training course is intended for Life Science companies such as pharmaceutical manufacturers (both drug substance and drug product), medical device manufacturers, and those companies conducting or sponsoring clinical trials. In addition to these regulated companies, this course will be of value to software vendors and SaaS/cloud providers.

Learning Objectives:

  • Understand the concepts behind 21CFR Part 11
  • Understand data integrity and how it relates to computerized system implementation and usage
  • How to manage a CSV project
  • The components of computer system validation
  • The types of computerized systems
  • Legacy systems and the predicate rule
  • Documentation requirements
  • Computerized system audits
  • Change control requirements
  • Quality Management System requirements
  • Privacy requirements
  • Risk assessments
  • Software life cycle management

Areas Covered :

  • Documentation requirements that demonstrate software validation and computer system validation.
  • The specific requirements associated with local and SaaS/cloud hosting solutions.
  • The importance of validating the quality process and every computerized system used in laboratory, clinical, and manufacturing settings.
  • Data integrity risk assessments
  • How to perform internal audits to verify successful software implementation

Who will Benefit:

This CSV Training Course will benefit those responsible for the selection, implementation, validation, and maintenance of computerized systems in the Life Sciences industry. These include regulatory, clinical, and IT professionals working in the health care, clinical trial, biopharmaceutical, and medical device sectors. It is essential for software vendors, auditors, and quality staff involved in GMP / GCP / GLP applications.

  • Regulatory Affairs
  • QA/ QC managers and supervisors
  • IT Managers
  • Project Managers
  • Manufacturing Managers
  • Software vendors and suppliers
Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure
Day 01(8:30 AM - 4:30 PM)
  • 8:30-8:59 Registration Meet & Greet.
  • 9:00 AM -10:00 AM: Session 1 – Introduction Session objectives – introduce the topic, regulatory and safety basis, discuss Part 11 / Data Integrity issues observed personally and cited by FDA
    • What is CSV?
    • Part 11 compliance – what does that mean?
    • Data Integrity and Risk – why important?
    • Personal Audit Experience
  • 10:00 AM -11:00 AM: Session 2 – CSV Concepts and Definitions Session objectives – establish computer system validation scope, introduce terminology
    • Legacy systems and predicate rule
    • Computerized system configurations
      • In-house networks
      • SaaS
    • Software types
      • COTS
      • Custom Development
      • Spreadsheets
    • Software Lifecycle
    • Validation / Validated State and Change Control
    • Privacy Issues – HIPAA, GDPR
    • Roles / Responsibilities
  • 11:00 AM-12:00 Noon Session 3 – CSV Elements in a Quality Management System Session objectives – establish relationship between site’s QMS procedures and CSV
    • Validation Master Plan
    • Validation Documentation
    • Change Control
    • Life cycle Management
    • Security Management
    • Operational SOPs
  • 12:00 Noon - 1:00 PM: Lunch
  • 1:00 PM-1:30 PM" Session 4 – Exercise “Getting a Feel for CSV” Session objectives – engage attendees in an exercise to understand the concept of user requirements and the level of detail required for CSV
    • Identify User Requirements Specifications (URS) for a simple QC lab application to track HPLC column usage
    • Document URS in sufficient detail to later develop Functional Requirements and Test Cases (see Session 6).
  • 1:30 PM-3:00 PM: Session 5 – Documentation Requirements (1.5 hr) Session objectives – introduce attendees to the range and types of required documentation
    • User Requirements Specifications
    • Functional Requirements Specifications
    • Design Specifications
    • Test Cases / Test Scripts
    • Traceability Matrix
  • 3:00 PM-4:00 PM: Session 6 – Exercise “Getting a Feel for CSV – Part 2” Session objectives – engage attendees in the level of detail and inter-relationship of documentation
    • User Requirements Specifications
    • Functional Requirements Specifications
    • Test Cases
  • 4:00 PM-4:30 PM: Session 7 – CSV Protocols Session objectives – familiarize attendees with IQ/OQ/PQ documents and routing / approval process
    • Protocol Format
    • Protocol Procedures
    • Deviation from Protocols
Day 02(8:30 AM - 4:00 PM)
  • 8:30-8:59 Registration Meet & Greet.
  • 9:00 AM-09:30 AM: Session 8 – Life Cycle - Going Live Session objectives – understanding of software lifecycle with steps required prior to software usage
    • Roles
    • Data Migration
    • Account Management
    • Physical / Network security
    • Training
    • Disaster Recovery
    • Service Level Agreements
    • Incident Management, CAPAs
  • 9:30 AM-10:30 AM: Session 9 – Life Cycle - Maintenance Session objectives – understanding of software lifecycle with steps required to maintain software
    • Software Updates / Patches
    • Regression Testing
    • Change Control
    • Backup / Restore
    • Archive / Retrieval
  • 10:30 AM-11:00 AM: Session 10 – Decommissioning Session objectives – understanding software lifecycle with steps required to retire software
    • Migration
    • Archive
    • Hardware / Virtual Hardware Decommissioning
  • 11:00 AM-12:00 NoonSession 11 – Special Cases Session objectives – understanding of 2 additional types of validation
    • Retrospective Validation
    • Spreadsheet Validation – attendee exercise
  • 12:00 Noon-1:00 PM: Lunch
  • 1:00 PM-2:00 PM: Session 12 – Other Topics Session objectives – create awareness of security / risk issues around computerized systems
    • Password management (OS / application)
    • Implementation strategy – re-engineer to improve then automate
    • Security – USB ports / viruses
    • Roles
  • 2:00 PM-3:00 PM: Session 13 – Data Integrity Risk Assessment Session objectives – understanding of how to create a risk assessment and risk mitigation activities
    • Attendees will be provided with a data flow chart and will be asked to evaluate the risk at each data collection step and identify risk mitigation activities
  • 3:00 PM-4:00 PM: Session 14 – Auditing Computerized Systems Session objectives – what to look for during an internal audit
    • What do Health Authorities look for?
    • How to conduct internal audits
Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure
George Bernstein

George Bernstein
Principal, Double Dragon Consulting, Inc.

George Bernstein, Ph.D., is a Principal with Double Dragon Consulting, Inc., a consulting firm with a network of Subject Matter Experts located in the US, Europe, and Asia Pacific (China, India). Dr. Bernstein has a Ph.D. in Chemical Engineering and over 30 years of experience in pharmaceutical manufacturing, laboratory operations, data integrity, effective training, and quality risk management. Since 1988, Dr. Bernstein has consulted internationally with major pharmaceutical companies. He has lectured on quality systems and root cause analysis to industry trade groups, quality organizations, and at Interphex. In 1998, Dr. Bernstein led the development, validation, and implementation of an electronic batch record system for a client. This system is still in use today.

Dr. Bernstein’s experience, insights, and innovative problem solving have been integral to his work which ranges from GMP compliance, facility design, construction, and commissioning to business process re-engineering and process optimization. He has developed global quality standards (GLP, GCP, GPP) for a major international pharmaceutical company, and has assisted many clients with audit preparation, remediation activities, and communications with the US FDA.

Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure

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

By order form / PO#

Payment Mode

By Check -
Pay your check to (payee name) “MetricStream Inc” our parent company and Mail the check to:

ComplianceOnline (MetricStream, Inc),
6201 America Center Drive Suite 240
San Jose, CA 95002

By Wire -

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 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:

Media Partner

Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure

Local Attractions of Los Angeles, CA

Griffith Observatory

Griffith Observatory

Griffith Observatory is an icon of Los Angeles, a national leader in public astronomy, a beloved civic gathering place, and one of southern California's most popular attractions. The Observatory is located on the southern slope of Mount Hollywood in Griffith Park, just above the Los Feliz neighborhood. It is 1,134 feet above sea level and is visible from many parts of the Los Angeles basin.

Universal Studios Hollywood

Universal Studios Hollywood

Universal Studios Hollywood is a movie studio and theme park in the Los Angeles County, California, United States. It is one of the oldest and most famous Hollywood movie studios still in use. Its official marketing headline is "The Entertainment Capital of LA", though during the summer it is often advertised as "The Coolest Place in LA. It is the first of many full-fledged Universal Studios Theme Parks located across the world.

Los Angeles County Museum of Art

Los Angeles County Museum of Art

The Los Angeles County Museum of Art (LACMA) is the largest art museum in the western United States. It attracts nearly a million visitors annually. Its holdings of more than 100,000 works span the history of art from ancient times to the present. In addition to art exhibits, the museum features film and concert series.

Beverly Center

Beverly Center

Beverly Center Shopping Mall is a large indoor shopping center located near Beverly Hills. Beverly Center is Southern California's premier fashion destination with over 100 distinctive specialty boutiques reflecting the diverse styles and tastes of Los Angeles. The Center is anchored by Bloomingdale’s, Macy’s and the upscale dining destination, The Capital Grille.

Venice Beach

Venice Beach

Venice Beach is a seaside neighborhood of Los Angeles. Named for its series of canals, Venice is known as a haven for creative types. It is famous for its bohemian boardwalk and for the eclectic Abbot Kinney Blvd. Venice Beach include the beach, the promenade that runs parallel to the beach (“Ocean Front Walk” or just “the boardwalk”), Muscle Beach, the handball courts, the paddle tennis courts, Skate Dancing plaza, the numerous beach volleyball courts, the bike trail and the businesses and residences that have their addresses on Ocean Front Walk.

Los Angeles Zoo and Botanical Gardens

Los Angeles Zoo and Botanical Gardens

The Los Angeles Zoo and Botanical Gardens is located in Los Angeles Griffith Park. The Zoo is home to more than 1,100 mammals, birds, amphibians and reptiles representing more than 250 different species of which 29 are endangered. In addition, the Zoo’s botanical collection comprises several planted gardens and over 800 different plant species with over 7,400 individual plants. The Zoo receives over 1.5 million visitors per year.

Staples Center

Staples Center

Staples Center is a multi-purpose sports arena in Los Angeles. It is one of the major sporting facilities in the Greater Los Angeles Area. The arena is home to the Los Angeles Lakers and the Los Angeles Clippers of the National Basketball Association (NBA), the Los Angeles Kings of the National Hockey League (NHL), and the Los Angeles Sparks of the Women's National Basketball Association (WNBA).

Watts Towers

Watts Towers

The Watts Towers are a complex set of 17 separate sculptural pieces built on a residential lot in the community of Watts. Two of the towers rise to a height of nearly 100 feet. The Watts Towers are one of only nine works of folk art listed on the National Register of Historic Places. The site is one of only four US National Historic Landmarks in the city of Los Angeles.

Getty Center

Getty Center

The Center houses a comprehensive collection of Western art from medieval times to the present, with particular strengths in alchemical texts, Italian futurism, Russian Modernism, Japanese avant-garde art and artists’ letters and sketchbooks throughout the ages. The Center’s campus features numerous garden spaces, fountains and pools as well as outdoor sculptures. The center draws 1.3 million visitors annually.

Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure

We need below information to serve you better

Best Sellers
You Recently Viewed