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Computer System Validation - 7 Courses to Boost your Knowledge - Webinar

  • ID: 3673947
  • Webinar
  • Region: Global
  • Online Compliance Panel
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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.

CD/Recorded-How It Works:

- Webinar CD/Recorded will have a series of modules. Our experts have delivered the modules using PowerPoint Presentations
- Webinar Recording Link or CDs are licensed to be used multiple times at any location with multiple attendants
- Get unlimited access for Recorded links
- Free shipment of CDs within 72 hours from the date of purchase
- Reference materials for Webinar Recording Link/CDs will be mailed to your registered e-mail id

Webinar Topics:

- Computerized System Validation: Basic Concepts
- Computer System and Software Validation
- Best Practices for Documenting a Computer System Validation Process
- Applying Computer System Validation to Mobile Applications
- Validation and Use of Cloud Computing in FDA Regulated Environment
- Software Validation-Avoiding FDA Warning Letters and Consent Decree
- Systems Validation Made Easy

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
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Webinars included in the Package:

1. 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

2. 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

3. 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

4. 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

5. 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

6. 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

7. 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
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  • Angela Bazigos Ms Angela Bazigos,
    CEO ,
    Touchstone Technologies Silicon Valley

    Angela Bazigos.CEO of Touchstone Technologies Inc. She has 40 years of experience in the Life Sciences & Healthcare Industries. Experience combines Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety, Turnarounds and Business Development. Past employers / clients include Roche, Novartis, Genentech & PriceWaterhouseCoopers. Positions include Chief Compliance Officer at Morf Media. Co-authored & prototyped 21 CFR 11 guidance with FDA. Co-authored Computerized Systems in Clinical Research w/ FDA. Patent on speeding up software compliance. Recently quoted in Wall Street Journal for using training to bring regulatory compliance to the Boardroom. National Trainer for Society of Quality Assurance. Comments / collaborates with FDA on new guidance documents. Former President of Pacific Regional Chapter of Society of Quality Assurance. Stanford’s Who’s Who for Life Sciences.

  • Peter Spath Peter Spath,
    Freelance Consultant ,
    Medical Device Industry

    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.

    In addition to his expertise in Quality Systems and Regulatory requirements for Medical Devices, Mr. Spath has served on EPA committees to develop new regulations for environmental laboratory accreditation. He was also appointed to the Environmental Laboratory Accreditation Board, an EPA Federal Advisory Committee (FACA), providing advice to the EPA Agency Administrator.

  • Carolyn Troiano Carolyn Troiano,
    Webinar/Seminar/Workshop Instructor in FDA Compliance Training

    Carolyn Troiano has more than 35 years of experience in the tobacco, pharmaceutical, medical device and other FDA-regulated industries. She has worked directly, or on a consulting basis, for many of the larger pharmaceutical and tobacco companies in the US and Europe, developing and executing compliance strategies and programs

  • Ludwig Huber Dr Ludwig Huber,
    Director and Chief Editor ,

    Dr. Ludwig Huber is Director and Chief Editor of www.labcompliance.com, the global on-line resource for validation and compliance issues for laboratories . Mr. Huber is an expert for FDA and equivalent international compliance and for ISO/IEC 17025 laboratory accreditation. He is also the Chairman, presenter and panel discussion member at US-FDA industry training sessions and conferences.

    He served as a team member of PDA's task forces "21 CFR Part 11", of US-FDA internal documents, and of the GAMP® special interest group on laboratory equipment. In addition, he was awarded as Presenter of the Year of the Institute for Validation and Technology. He is the author of the books “Validation and Qualification in Analytical Laboratories, and "Validation of Computerized Analytical and Networked Systems", Interpharm Press.

  • Mukesh Kumar Dr Mukesh Kumar,
    Senior Director, Regulatory Affairs ,
    Amarex Clinical Research

    Dr. Mukesh Kumar is a Washington DC-based consultant in regulatory affairs and quality assurance for manufacturers and developers of FDA-regulated products. He leads the regulatory affairs and quality assurance departments at Amarex, a full service pharmaceutical product development company based in Germantown, MD. His key expertise is in regulatory affairs, clinical trials and multi-national project management for medicinal and diagnostic products. He has been involved in about more than 100 clinical trials in more than 40 countries, has made hundreds of US FDA submissions, and arranged a number of meetings with the US FDA. In addition, he has had made regulatory submission in the EU, Taiwan, Korea, China, Canada, countries in South America, Australia, and India. He has conducted GCP, GLP, GMP and GACP audits in the US and several countries in Europe, North and South Americas and Asia.

    Dr. Kumar has conducted numerous training workshops in FDA compliance related issues. He has authored numerous articles in peer-reviewed journals. He is a well-known expert in global regulatory affairs and has been an invited speaker in several professional and academic organizations worldwide. Dr. Kumar is a PhD in Biochemistry and is a certified regulatory affairs professional by the Regulatory Affairs Professional Society, USA.

  • Herman Wong Herman Wong,
    Director of Information Technology ,

    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. 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.

Note: Product cover images may vary from those shown