7 Computer System Validation Courses for Life Science Industry

The basic concepts of computerized system validation originated in the 1960s, with the Department of Defense and NASA. Validation of systems became a growing issue within the pharmaceutical industry during the late 1980s and early 1990s, as the use of computerized technologies became commonplace in the research and manufacturing of drug products. The FDA issued a series of regulations and guidelines to define regulatory expectations for computerized system validation. In today’s environment, virtually all aspects of research and manufacturing are conducted using computerized systems, yet the planning, conduct, and necessary controls for validation of these systems remains problematic for many companies and industry professionals.
Instructor: Angela Bazigos, Peter Spath, Carolyn Troiano, Dr. Ludwig Huber, Mukesh Kumar, Herman Wong
Product ID: PACK70033

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Webinar Topics:

Who will benefit?

  • Project/Strategic Management
  • Quality Assurance Staff
  • IT Staff
  • Operations Staff
  • Quality Assurance Managers/Personnel
  • Regulatory Managers/Personnel
  • Manufacturing Managers, Supervisors & Personnel
  • Senior Management Executives (CEO, COO, CFO, etc.)
  • Project Managers
  • Information Technology Analysts
  • Clinical Data Managers and Scientists
  • Analytical Chemists
  • Compliance Managers
  • Automation Analysts
  • Computer System Validation Specialists
  • GMP Training Specialists
  • Everybody responsible for FDA compliance of computer systems
  • Managers from purchasing, documentation and operations
  • GLP/GMP/GCP Auditors
  • Teachers
  • T/QA personnel

Webinars included in the Package:

Computerized System Validation: Basic Concepts (Duration: 90 Minutes)

A well designed validation project will provide assurance of business continuity, and consequently provide assurance of regulatory compliance. This presentation will diminish the mystery associated with computerized system validation, provide attendees with a clear understanding of the basic concepts of validation, and describe the steps to be taken by a project team leading to a well controlled and successful computerized system validation.

Objectives of the Presentation:

  • Introduction, Historical Perspective, and Definitions
  • Computerized System Validation Master Plan
  • Validation Plan
  • Developer Assessment
  • Requirements, Design, and Configuration Specifications
  • Validation Testing
  • Procedures/Archival/Traceability
  • Validation Summary Report
  • Commissioning Memo
  • System Decommissioning/Retirement

Instructor Profile:

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.

Computer System and Software Validation (Duration: 90 Minutes)

This webinar will discuss ways Medical Device manufacturers can organize, document and prepare to present their software validation efforts during FDA Investigations or ISO Registrar audits. Any organization using computer systems to control manufacturing and test equipment, processes, or manage records must validate the software for its intended use. Software validation can appear to be an intimidating endeavor when an organization considers the number of systems in use.

Objectives of the Presentation:

  • What is involved in software validation
  • How to get your validation program started
  • How should an organization decide which systems require validation
  • How does an organization assure their systems are compliant
  • What written procedures and training are required
  • How do FDA Investigators assess compliance

Instructor Profile:

Peter Spath is currently a freelance consultant serving the Medical Device community by providing a variety of quality and regulatory consultation on contractual basis remotely and on-site. Services include: leading Quality System audits in accordance with ISO 9001, 17025, and 13485, Canada's CMDCAS regulations and FDA GMPs for both Medical Devices and Combination Devices. He has over 20 years of experience working with international regulations and standards as a Certified Lead Auditor. Recognized as an expert in ISO Standards and Federal Regulations, especially those governing Electronic Records and Electronic Signatures, he led regulatory compliance assessments throughout Fortune 500 Companies as well as their suppliers across the United States, Mexico, and Europe. Mr. Spath developed and facilitated the implementation of quality management systems in numerous internal organizations and key contract manufacturers in Germany. He has also successfully managed FDA GMP and EPA GLP investigations in a variety of organizations.

Best Practices for Documenting a Computer System Validation Process (Duration: 60 Minutes)

This course will describe the best practices for documenting validation work, including "who" should be responsible for such tasks and "how" the documentation should be accomplished. FDA guidelines are very specific in terms of how this is to be done. In addition, we will touch on elements of electronic records and electronic signatures (ER/ES, or FDA 21 CFR Part 11). Specific criteria must be met in order to consider such a signature as valid in the eyes of FDA regulators.

Objectives of the Presentation:

  • Computer system validation planning, execution and management concepts
  • steps required for documenting the validation process
  • Key documentation associated with maintaining the systems are in a validated state
  • How to leverage these practices across all systems by creating a standardized program

Applying Computer System Validation to Mobile Applications (Duration: 60 Minutes)

This webinar discusses how computer system validation can be applied to mobile applications subject to FDA regulations. This is critical in order to develop the appropriate validation strategy and achieve the thoroughness required to prove that a system does what it purports to do. It also ensures that a system is maintained in a validated state throughout its entire life cycle, from conception through retirement. The attendees will understand the level of effort required for executing each phase of the SDLC, and the appropriate level of documentation that must be completed to support it. They will also gain an understanding of the training and skills required when validating or maintaining mobile applications.

Objectives of the Presentation:

  • How mobile applications should be handled when performing validation work
  • Best practices for maintaining a mobile application in a validated state
  • Best practices necessary to ensure all systems, including mobile applications, are validated appropriately
  • How to develop the appropriate computer validation strategy when dealing with mobile applications to ensure a good balance of cost vs. risk
  • How to effectively document the process of computer system validation, and maintain current information about the various systems in your organization, as they begin to include mobile applications
  • Learn how to gain information about trends in validation of mobile applications, as industry progresses and new best practices emerge
  • Understand some of the key "pitfalls" to avoid when applying the concepts of computer system validation to mobile applications

Instructor Profile:

Carolyn Troiano has more than 30 years of experience in computer system validation in the pharmaceutical, medical device, animal health and other FDA-regulated industries. She is currently managing a large, complex data migration, analytics and reporting program at a major financial institution. Carolyn developed validation programs and strategies back in the mid-1980s, when FDA guidelines were first issued. She was an industry reviewer for 21 CFR Part 11, the FDA’s electronic record/electronic signature (ER/ES) regulation. She has taught ER/ES compliance, along with computer system validation and risk management/compliance at a number of Fortune 100 firms.

Creating a Good Validation and Use of Cloud Computing in FDA Regulated Environment (Duration: 75 Minutes)

Cloud computing can significantly reduce investment and operating costs for IT operations. However, when used in FDA and other regulated environments they need to be validated to ensure consistent on-going performance and security and integrity of stored and managed data. While there are guidelines available on how to deal with standard networks and computer systems this is not the case for virtual networks and cloud computing.

Objectives of the Presentation:

  • Benefits of virtual networks and cloud computing
  • Possible issues when used in FDA regulated environments
  • Recommendations from official task forces
  • Different models: Infrastructure, platform and software as a service
  • Recommendations for different cloud versions: Internal/external private, public
  • Validation of cloud vs. traditional computers
  • How to deal with major issues: Security, data availability and data integrity
  • Going through a complete project for cloud computing validation
  • Selecting the right cloud provider for compliance
  • What and how much to test and documents for different cloud models
  • Considerations for formal agreements with service providers
  • Step-by-step recommendations for using 'clouds' from planning to reporting
  • Putting everything together: Documentation for the FDA and every other agency
  • Best practices

Instructor Profile:

Ludwig Huber, Ph.D., is the director of Lab compliance, the global online resource for validation and compliance. He is the author of the books "Validation and Qualification in Analytical Laboratories" and "Validation of Computerized Analytical and Networked Systems". He has given more than 300 presentations mainly on GLP/GMP, 21 CFR Part 11 and Validation around the world.

Software Validation- Avoiding FDA Warning Letters and Consent Decree (Duration: 90 Minutes)

Software validation issues with computerized systems are responsible for multiple product recalls as well. Improper or ineffective software validation leads to finding of deficient quality systems during FDA audits. This webinar provides practical tips for achieving FDA-acceptable software validation of general computer systems and computerized equipment. Case studies are used to highlight common mistakes and possible solutions.

Objectives of the Presentation:

  • Reviewing FDA Warning Letters and Consent decrees related to software
  • Common FDA audit findings for software validation
  • Best practices to bring software into compliance

Instructor Profile:

Mukesh Kumar leads the Regulatory Affairs and Quality Assurance departments at Amarex Clinical Research, a full service CRO based in Germantown, MD. His key expertise is in developing Global Regulatory Business Strategies for biomedical product development and his passion is to bring traditional therapies for India, China and the Latin-America to the Western markets. In addition to regulatory expertise, Mukesh is an experienced auditor and a trainer in regulatory and business processes. With more than 11 years of experience in virology, gene therapy, and molecular biology, Mukesh has expertise in biological and combination products. He has been a global Regulatory Affairs Specialist (US, EU, and India) for the last 5 years.

Systems Validation Made Easy (Duration: 60 Minutes)

This webinar discusses the basics of computerized systems validation and the procedural controls to maintain compliance. Validation is on-going effort from development all the way to eventual retirement. This webinar talks about validation plans, user requirements, test plans, test reports, change controls, standard operating procedures, data backup and business continuity. Case studies are used to highlight common issues and potential solutions.

Objectives of the Presentation:

  • Validation Plans, Requirements, Specifications, and Test Reports
  • Recommended SOPS
  • Change control
  • Data backup and business continuity
  • Tips when validating COTS software
  • Common audit findings and tips for a successful audit

Instructor Profile:

Herman Wong is a Washington DC-based consultant for computer systems in FDA-regulated industry. He has been in the industry for over 12 years and is the Director of the Information Technology department at Amarex, a full service pharmaceutical product development company based in Germantown, MD (www.amarexcro.com). His key expertise is in training of IT personnel in FDA-regulated industry, creating, managing and implementing Part 11 compliant computer systems. Since 2005, Mr. Wong has been evaluating EDC systems for Part 11 compliance at small and big organizations including some of the largest US federal organizations and large pharmaceutical companies.

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