RAPS: This course has been pre-approved by RAPS as eligible for up to 15.0 credits towards a participant's RAC recertification upon full completion.
A 3-Day Complete Immersion in the Validation Process
Please bring a laptop to boot camp. You will need internet access, spreadsheet and word processing applications and a PDF reader.
Advancements in technology have forced organizations to rethink business models. Once controlled and orderly, these organizations are now more chaotic and complex, serving patients and customers that are better informed and with higher expectations than ever before. Work practices and tools must change to meet these challenges.
The approach to developing software, performing validation and maintaining a system in a validated state through its entire life cycle should be carefully considered in order to meet changing needs. This seminar will include a comparison of the agile and waterfall methodologies, along with the pros and cons of each. There may not be one size that fits all, and so it is important to understand what needs to be considered when making such a determination.
We’ll also cover COTS, SaaS, IaaS, PaaS, and cloud services, indicating the benefits and risks of each model. In discussing these hardware and software options, we’ll include the best practices for meeting FDA’s requirements for validation, 21 CFR Part 11, as applicable, and data integrity. Part of the session will identify the FDA’s current concerns and how to ensure your systems will meet their expectations.
A 3-Day Complete Immersion in the Validation Process
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
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
Advancements in technology have forced organizations to rethink business models. Once controlled and orderly, these organizations are now more chaotic and complex, serving patients and customers that are better informed and with higher expectations than ever before. Work practices and tools must change to meet these challenges.
The approach to developing software, performing validation and maintaining a system in a validated state through its entire life cycle should be carefully considered in order to meet changing needs. This seminar will include a comparison of the agile and waterfall methodologies, along with the pros and cons of each. There may not be one size that fits all, and so it is important to understand what needs to be considered when making such a determination.
We’ll also cover COTS, SaaS, IaaS, PaaS, and cloud services, indicating the benefits and risks of each model. In discussing these hardware and software options, we’ll include the best practices for meeting FDA’s requirements for validation, 21 CFR Part 11, as applicable, and data integrity. Part of the session will identify the FDA’s current concerns and how to ensure your systems will meet their expectations.
Course Content
Day 1Day 2Day 3
Module 1: CSV Methods and Models
Module 2: Software and Services
Module 3: CSV Planning
Module 4: System Requirements and Design
Day 1
Module 5: IQ, OQ, PQ Test Planning & Execution
Module 6: Test and Validation Reports
Module 7: CSV Operations and Maintenance
Module 8: CSV Supporting Components
Module 9: Managing FDA-Regulated Data
Module 10: Vendor Audit
Module 11: FDA Trends
Module 12: Inspection Preparation
Day 3
Module 13: CSV Exercises
Course Provider
Faculty Carolyn Troiano,
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
