- Analytical Instrument Qualification and Computer System Validation
This 2-day course guides attendees through equipment qualification, calibration and computer system validation processes from planning to reporting. It also explains regulatory requirements in these areas, including EU and US GMPs, as well as data integrity guidance documents from national and international regulatory bodies.
- 21 CFR Part 11, Data Integrity, and Computer System Validation
Understand the importance of 21 CFR Part 11 to the software lifecycle and why it is often mistaken for the sum total of validation requirements, Understand the objectives of global regulatory bodies in their oversight of regulated software, Understand the importance of confidentiality, integrity, and availability (i.e. CIA) in the software lifecycle
- Developing a Strategic Approach to FDA Compliance for Computer Systems
This webinar will help you understand in detail Computer System Validation (CSV) and how to apply the System Development Life Cycle (SDLC) Methodology when validating computer systems subject to FDA regulations, which is critical in order to be able to develop the appropriate validation strategy and achieve the thoroughness required to prove that a system does what it purports to do.
- Good Documentation Practice (GDP) and FDA Validation Compliance for Regulated Computer Systems and Data
Computer system validation has been regulated by FDA for more than 30 years, as it relates to systems used in the manufacturing, testing and distribution of a product in the pharmaceutical, biotechnology, medical device or other FDA-regulated industries. The FDA requirements ensure thorough planning, implementation, integration, testing and management of computer systems used to collect, analyze and/or report data.
- Computer System Validation: Step-by-Step
Learn computer system validation essentials and eight fundamental steps of implementation for cost saving. Get complementary SOPs and checklists for easy implementation. Understand the structure of validation plan, documentation of ongoing performance, and structure of validation report.
- FDA Modernization and Restructuring of the SDLC for Computer System Validation (CSV) and Compliance
This webinar will focus on the efforts by FDA to modernize their own technology infrastructure, and what this means to industry. We will cover the Technology Modernization Action Plan (TMAP) that has been launched by FDA for this purpose and discuss specific actions that are planned and in progress.
- Risk-Based Approach to CSV, 21 CFR Part 11 and FDA Compliance
This webinar will help you understand in detail Computer System Validation (CSV) and how to apply the System Development Life Cycle (SDLC) Methodology when validating computer systems 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, and a key element is a thorough risk assessment.
- How to Comply with FDA Regulations for Tobacco-Related Products: Computer System Validation, 21 CFR Part 11, & Data Integrity
This webinar is intended for those working in the FDA-regulated tobacco and related industries, including e-liquids (vapor), e-cigarettes, cigars, and smokeless tobacco products. Functions that are applicable include research and development, manufacturing, Quality Control, distribution, clinical testing and management, adverse events management and post-marketing surveillance.
- Data Integrity Compliance for Computer Systems Regulated by FDA
Effective and compliant computer system validation is critical to any pharmaceutical or FDA-regulated organization. In this webinar, you will learn about these FDA trends in compliance and enforcement, as they relate to Data Integrity, and how to improve your practices to meet compliance requirements.
- Computer System Validation and Part 11 Compliance
This webinar will discuss in detail the requirements of 21 CFR part 11 and updated European Annex 11 regulation including requirements for local, SaaS, and cloud hosting. It will also offer techniques to implement a computer system using risk-based validation to gain maximum productivity and reduce cost by as much as two thirds.
- Best Practices in Preparation for an FDA Computer System Audit
FDA requires that all computer systems used to produce, manage and report on “GxP” (GMP, GLC, GCP) related products be validated and maintained in accordance with specific rules. This webinar will help you understand the FDA’s current thinking on computer systems that are validated and subject to inspection and audit. It will also consider areas where FDA will likely focus their effort, including on the higher-risk systems. It will cover areas that will help you to plan for an on-site inspection.
- 21 CFR Part 11, FDA's Guidance for Electronic Records and Electronic Signatures
The Webinar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11. This includes development of a company philosophy and approach, and incorporating it into the overall computer system validation program and plans for individual systems that have this capability.
- Project Management for Computer Systems Validation
This computer system validation training will highlight the principles of project management that can be applied to 21 CFR Part 11 compliance for Computer Systems Validation and show how you can use project management tenets to deliver on time and on budget, while meeting FDA regulatory compliance requirements.
This seminar will help you understand in detail Computer System Validation (CSV) and how to apply the System Development Life Cycle (SDLC) Methodology when validating computer systems subject to FDA regulations, which is critical in order to be able 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. We will discuss the phases within the SDLC, and how these form the basis for any CSV project that you may undertake, and the importance of the sequence of steps will also be covered, to ensure you are able to comply with FDA expectations.
Effective and compliant computer system validation is critical to any FDA-regulated organization. During the past 30 years, best practices have been developed and, if followed, can ensure laboratory computer systems are validated efficiently and in compliance with FDA regulations. This seminar will provide guidance for planning, executing and validating a laboratory computer system, and managing the system in a validated state through the end of the system life cycle.
The seminar will take you through the validation process, indicating key aspects of the approach, including GAMP 5 System Classification, Risk Assessment and overall development of a sound validation strategy. We will cover the actual validation phases, deliverables and key points to ensuring the work is in accordance with FDA requirements for computer system validation, while also making sure the approach is cost effective for your organization.
The seminar will also address roles and responsibilities, timing of phases and deliverables, business process reengineering, organizational change management, change control and audit trails, training and documentation. You will learn what is required not only to validate your laboratory system, but maintain it in a validated state until it is retired or otherwise no longer in use.
There is an enormous body of documentation and information available on computer system validation, which can be overwhelming. This course will provide a condensed overview of the practices that deliver the best results by directing the attendees to the most critical and cost-effective of methods, techniques and tools available.
Learning Objectives:
This seminar will help you understand in detail Computer System Validation (CSV) and how to apply the System Development Life Cycle (SDLC) Methodology when validating computer systems 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. We will discuss the phases within the SDLC, and how these form the basis for any CSV project. The importance of the sequence of steps will also be covered.
We will also cover Computer Software Assurance (CSA), the DRAFT Guidance from FDA on validation issued September 2022. CSA focuses on critical thinking rather than being driven by documentation and deliverables, as with traditional CSV. Both require a risk-based approach.
We’ll also cover GAMP®5, 2nd Edition which is aligned with the CSA approach. The course will cover cloud computing, Software-as-a-Service (SaaS) solutions and Commercial-Off-the-Shelf (COTS) packages. We’ll touch on 21 CFR Part 11 guidance from FDA on electronic records and electronic signatures, and data integrity compliance.
In-Person Seminar going Virtual with increased learner satisfaction.
Yes, attend this seminar from anywhere. We are making it real and more interactive – Here's a sneak peek:Our enhanced delivery process and technology provides you an immersive experience and will allow you to access:
- The real-time and live presentation as in in-person events
- Private chat for company-specific conversation – the same as you would get in an in-person seminar
- Opportunities to connect with your peers to share knowledge at a different time and have group discussions
- Live workshop activities
- Live Q&A during the event and offline Q&A assistance after the event
- As usual more content, activities and case studies and now adding homework for a comprehensive understanding
- Certification
Areas Covered:
- System Development Life Cycle (SDLC) Methodology
- Computer System Validation (CSV)
- Computer Software Assurance (CSA)
- Good “Variable” Practice (GxP)
- Good Manufacturing Practice (GMP)
- Good Laboratory Practice (GLP)
- GAMP®5, 2nd Edition Guidance for System Categorization
- Risk Assessment and Management
- Validation Strategy
- Change Control and Audit Trails
- User Requirements Specification (URS) & Functional Requirements Specification (FRS)
- System Design Specification (SDS) and System Configuration Specification (SCS)
- Test Planning, Execution and Documentation (IQ/OQ/PQ)
- Requirements Traceability Matrix (RTM)
- System Acceptance, Release Notification and Deployment
- System Retirement
- Data Governance
- Best Practices
- FDA Trends in Inspection and Enforcement
- Q&A
Who will Benefit:
Personnel in the following roles will benefit:
- Information Technology Analysts
- QC/QA Managers
- QC/QA Analysts
- Clinical Data Managers
- Clinical Data Scientists
- Analytical Chemists
- Compliance Managers
- Laboratory Managers
- Automation Analysts
- Manufacturing Managers
- Manufacturing Supervisors
- Supply Chain Specialists
- Computer System Validation Specialists
- GMP Training Specialists
- Business Stakeholders responsible for computer system validation planning, execution, reporting, compliance, maintenance and audit
- Consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance
- Auditors engaged in the internal inspection of labeling records and practices
- Module 1: Computer System Validation (CSV), Computer Software Assurance (CSA) and the System Development Life Cycle (SDLC) Methodology
- Recognizing GxP Systems
- Computer System Validation (CSV)
- Computer Software Assurance (CSA)
- Validation Planning
- GAMP®5, Second Edition and alignment with CSA
- Risk Assessment and Mitigation
- Module 2: System Requirements, Design/Configuration and Validation Testing
- Functional Requirements Specification (FRS)
- System, or Non-Functional Requirements
- System Design/Configuration Management Specification (SDS/CMS)
- Test Protocols and Summary Reports
- Requirements Traceability Matrix (RTM) Purpose and Contents
- Validation Summary Report
- Module 3: Maintenance and Change Management
- Change Control Process
- Security and Access
- Incident Reporting
- Disaster Recovery Planning/ Business Continuity Planning
- Record Retention
- Module 4: 21 CFR Part 11, FDA’s Guidance for ER/ES; Data Integrity and Privacy
- 21 CFR Part 11 Guidance Overview
- 21 CFR Part 11 Guidance and Compliance for Electronic Records/Signatures (ER/ES)
- Data Integrity
- Data Privacy
- Module 5: Software and Services; Vendor Audit
- Computer Off-the-Shelf (COTS) Software
- Cloud Systems
- Software-as-a-Service (SaaS)
- Vendor Audit
- Module 6: FDA Regulatory Influences and Compliance Trends
- Current Compliance and Enforcement Trends
- Industry Best Practices
- Q&A Session with the Presenter
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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 for In-person Seminars:
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.
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Cancellations and Substitutions for Virtual Seminars & Webinars:
Written cancellations through fax or email (from the person who has registered for the training) received at least 10 calendar days prior to the start date of the event will receive a refund — less a 30% administration fee. No cancellations will be accepted — nor refunds issued — within 10 calendar days from the start date of the event. On request by email or fax (before the training) a credit for the amount paid minus administration fees (30%) 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. Some topics and speakers may be subject to change without notice. Offers:
Carolyn Troiano
ERP Project Manager, City of Richmond
Carolyn Troiano has more than 40 years of experience in computer system validation in the pharmaceutical, medical device, animal health, tobacco, e-cigarette/e-liquid and other FDA-regulated industries.
During her career, Carolyn worked directly, or on a consulting basis, for many of the larger pharmaceutical companies in the US and Europe, developing validation programs and strategies, and collaborated with FDA and other industry representatives on 21 CFR Part 11, the FDA’s electronic record/electronic signature regulation.
