Boot Camp to explore in-depth the validation of computer systems regulated by the FDA. We will cover multiple approaches, techniques, and tools that can improve the efficiency and effectiveness of validation activities. You will go through the phases of validation, including deliverables and FDA requirements. You will also learn about 21 CFR Part 11, FDA’s guidance for electronic records and signatures, and for FDA’s guidance on Data Integrity.

Learning Objectives:-

• Learn how to identify “GxP” Systems
• Discuss the Computer System Validation (CSV) approach based on FDA requirements
• Learn about the System Development Life Cycle (SDLC) approach to validation
• Understand how to comply with key FDA and international CSV regulations and guidance, such as 21 CFR Part 11 and Annex 11
• Learn the purpose and content of each validation deliverable, including the Validation Plan, Requirements Specification, Test Plan, Validation Tests (IQ, OQ, PQ), Requirements Traceability Matrix, Test Summary, and Validation Report, etc.
• Understand the need to include an assessment of a computer system’s size, complexity, business criticality, GAMP®5 category, and risk, should it fail, develop a cohesive and comprehensive validation rationale
• Comprehend the risk-based validation techniques and how to leverage these techniques to create efficient yet compliant validation approaches
• Learn appropriate validation strategies for many types of applications, including Cloud/SaaS, COTS, spreadsheets, and custom-developed systems
• Discuss the best practices for documenting computer system validation efforts, including requirements, design, development, testing, and operational maintenance procedures
• Understand how to maintain a system in a validated state through the system’s entire life cycle
• Learn how to assure the integrity of data that supports GxP work
• Learn about the policies and procedures needed to support your validation process and ongoing maintenance of your systems in a validated state
• Know the regulatory influences that lead to FDA’s current thinking at any given time
• Learn how to best prepare for an FDA inspection or audit of a GxP computer system
• Understand the importance of performing a thorough vendor audit to ensure oversight of the products and services they deliver
• Finally, understand the industry best practices that will enable you to optimize your approach to validation and compliance, based on risk assessment, to ensure data integrity is maintained throughout the entire data life cycle
• Q&A

Background:-

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.

Electronic records and electronic signatures (ER/ES) came into play through guidelines established by FDA in 1997 and disseminated through 21 CFR Part 11. This code describes the basic requirements for validating and documenting ER/ES capability in systems used in an FDA-regulated environment.

In the early 2000s, FDA recognized they could not inspect every computer system at every regulated company and placed the onus on industry to begin assessing all regulated computer systems based on risk. The level of potential risk, should the system fail to operate properly, needed to be the basis for each company’s approach to developing a validation approach and rationale as part of the planning process. System size, complexity, business criticality, GAMP 5 category, and risk rating are the five key components for determining the scope and robustness of testing required to ensure data integrity and product safety.

FDA’s recent focus on data integrity during computer system validation inspections and audits has brought this issue to the forefront of importance for compliance of systems used in regulated industries.  These include all systems that “touch” products, meaning they are used to create, collect, analyze, manage, transfer and report data regulated by FDA. All structured data, including databases, and unstructured data, including documents, spreadsheets, presentations, and image files, audio and video files, amongst others, must be managed and maintained with integrity throughout their entire life cycle.

We will explore the best practices and strategic approach for evaluating computer systems used in the conduct of FDA-regulated activities and determining the level of potential risk, should they fail, on data integrity, process and product quality, and consumer/patient safety. We will walk through the System Development Life Cycle (SDLC) approach to validation, based on risk assessment, and will also discuss 21 CFR Part 11 and the importance of managing electronic records and signatures appropriately.

We will also walk through the entire set of essential policies and procedures, as well as other supporting documentation and activities that must be developed and followed to ensure compliance. We will provide an overview of practices to prepare for an FDA inspection, and will also touch on the importance of auditing vendors of computer system hardware, software, tools and utilities, and services.

Finally, we will provide an overview of industry best practices, with a focus on data integrity and risk assessment that can be leveraged to assist in all your GxP work.

Agenda:- Day 1

July 25, Monday, 2022 (1:00 PM to 3:00 PM)

• GxP” Systems
• Computer System Validation (CSV)
• Computer Software Assurance (CSA)
• System Development Life Cycle (SDLC)
• CSV regulations and guidance, such as 21 CFR Part 11 and Annex 11
• Validation deliverables, including the Validation Plan, Requirements Specification, Test Plan, Validation Tests (IQ, OQ, PQ), Requirements Traceability Matrix, Test Summary, and Validation Report, etc.

Agenda:- Day 2

July 26, Tuesday, 2022 (1:00 PM to 3:00 PM)

• Develop a cohesive and comprehensive validation rationale
• Comprehend a risk-based validation technique
• Learn appropriate validation strategies for Cloud/SaaS, COTS, spreadsheets, and custom-developed systems
• Learn best practices for documenting validation
• Maintain a system in a validated state
• Assure the integrity of data that supports GxP work

Agenda:- Day 3

July 27, Wednesday, 2022 (1:00 PM to 3:00 PM)

• Policies and procedures needed to support validation
• FDA’s current thinking and trends
• FDA inspection or audit preparation
• Vendor Audit
• Finally, understand the industry best practices that will enable you to optimize your approach to validation and compliance, based on risk assessment, to ensure data integrity is maintained throughout the entire data life cycle
• Q&A

Why Should You Attend:-

We have used our real-world experience to design a computer system validation course that not only meets FDA, ICH, and Eudralex expectations for risk-based validation but also prepares you to implement these practices in your company. The standard operating procedures and validation templates used in class have already been proven at other companies.

We are focused on your comprehension and application of the CSV techniques that will result in efficient, effective, and inspection-ready validation initiatives

Who Should Attend:-

• Information Technology Analysts
• Information Technology Developers and Testers
• Software Quality Assurance Professionals
• QC/QA Managers and Analysts
• Analytical Chemists
• Compliance and Audit Managers
• Laboratory Managers
• Automation Analysts
• Manufacturing Specialists and Managers
• Supply Chain Specialists and Managers
• Regulatory Affairs Specialists
• Regulatory Submissions Specialists
• Risk Management Professionals
• Clinical Data Analysts
• Clinical Data Managers
• Clinical Trial Sponsors
• Computer System Validation Specialists
• GMP Training Specialists
• Business Stakeholders/Subject Matter Experts
• Business System/Application Testers
• Vendors responsible for software development, testing, and maintenance
• Vendors and consultants working in the life sciences industry who are involved in computer system implementation, validation, and compliance