CSV Boot Camp - 3-Day Certification Course (Recorded)

Registration Includes:

• Checklist of documents and the direction for how to create
• Course Material
• Exercises to get a grasp on practical approaches.
• Final Examination and Evaluation
• Training Certification
• Hands-On Training
• A course designed to completely immerse you in computer system validation. This course delivers comprehension of the regulations impacting your systems and hands-on practice writing validation documents. You will leave ready to lead efficient, effective, inspection- ready validation projects.

Please bring a laptop to boot camp. You will need internet access, spreadsheet and word processing applications and a PDF reader.

EXERCISES: Independent Study

The following exercises will be included in the course content and can be completed at each attendee’s discretion. If completed before the end of the Boot Camp, the attendee may ask questions during any Q&A session. If completed after the Boot Camp, the attendee may ask questions via Compliance Trainings and a response will be sent as quickly as possible. Note that both questions and answers are provided for each exercise.

• Exercise 1: Exploring the Regulations using the fda.gov website
• Exercise 2: FDA Guidance for ER/ES
• Exercise 3: Validation Master Plan (VMP) Writing
• Exercise 4: Interviews and URS/FRS Writing
• Exercise 5: IQ, OQ, PQ Test Protocol Writing
• Exercise 6: RTM Writing
• Exercise 7: VSR Writing
• Exercise 8: Be the Consultant - Example of a Data Integrity Audit by FDA at a pharmaceutical manufacturer

CSV Final Exam: Completed at the discretion of the attendee. Note that both questions and answers are provided for each exercise. (100 Questions/Answers)

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” product, 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 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.

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.

SEMINAR OBJECTIVES

1. Learn how to identify “GxP” Systems
2. Discuss the Computer System Validation (CSV) approach based on FDA requirements
3. Learn about the System Development Life Cycle (SDLC) approach to validation
4. Understand how to comply with key FDA and international CSV regulations and guidance, such as 21 CFR Part 11 and Annex 11
5. 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.
6. Comprehend the risk-based validation techniques and how to leverage these techniques to create efficient yet compliant validation approaches
7. Learn appropriate validation strategies for many types of applications, including Cloud/SaaS, COTS, spreadsheets, and custom developed systems
8. Become aware of best-practices and inspector expectations for computer system validation and software quality assurance (SQA) programs
9. Discuss the best practices for documenting computer system validation efforts, including requirements, design, development, testing and operational maintenance procedures
10. Understand how to maintain a system in a validated state through the system’s entire life cycle
11. Learn how to assure the integrity of data that supports GxP work
12. Discuss the importance of “GxP” documentation that complies with FDA requirements
13. Learn about the policies and procedures needed to support your validation process and ongoing maintenance of your systems in a validated state
14. Understand the key components of 21 CFR Part 11 compliance for electronic records and signatures
15. Know the regulatory influences that lead to FDA’s current thinking at any given time
16. Learn how to conduct a risk assessment on computer systems that will provide the basis for developing a validation rationale
17. Understand the need to include an assessment of a computer system’s size, complexity, business criticality, GAMP 5 category and risk, should it fail, to develop a cohesive and comprehensive validation rationale
18. Learn how to best prepare for an FDA inspection or audit of a GxP computer system
19. Understand the importance of performing a thorough vendor audit to ensure oversight to the products and services they deliver
20. 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
21. Interactive Q&A Session