Learn How To Think Like The FDA ®
FDA-oRIENTED
“Established since 1999”
GUERRA
consultinggroup,inc.™
REGULATORY COMPLIANCE SERVICES
- Define and comply with FDA regulatory requirements on CSV, Part 11 and Data Integrity in computerized systems applicable to Laboratory and Manufacturing Operations.
- Understand the fundamentals of a Master Validation Plan for CSV applications.
- Learn how to develop and execute DQ, IQ, OQ and PQ validation protocols.
- Implement User Requirements, Functional Specifications and Functional Testing during the life cycle of the laboratory and/or manufacturing application.
- Develop a change control program during deployment of CSV and Part 11 applications.
- Adapt internal procedures to develop adequate CSV documentation.
- Learn how to audit CSV documents.
- Maintain data reliability in automated applications.
- Learn the ins and outs of software vendor qualifications and vendor audits.
- Work with computer/software vendors/suppliers to minimize regulatory breach.
- Understand cGMP limitations of third-party validations and software validation packages.
- Learn audit trail review limitations during the evaluation of Data Integrity in computerized systems.
- Prepare a Quality Risk Management assessment strategy to validate software applications in order to pass an audit.
- Implement validation programs for automated equipment.
- Learn how to document Failure Investigations and Quality Events related to automated equipment and computerized laboratory instruments.
- Define and apply remedial action plans (CAPA) under a software maintenance program.
PROGRAM
BENEFITS
GCGI’s CSV CERTIFICATION PROGRAM™
Learn the actual validation process of a laboratory "Chromatography Data Software (CDS)".
All validation documents included.
Use them as reference or templates for CSV projects.
Is available through online webinars. Training activities are presented live including individual and group discussions, workshop exercises and Q&A sessions.
Real case studies - adding interest and depth to CSV Training Modules
WORKSHOP EXERCISES
GCGI’s CSV CERTIFICATION PROGRAM™
Get Certified Now!
Become a leader as a CVS Subject Matter Expert (SME).
CSV Certification
Program
CDS real-life example:
The Computer System Validation (CSV) Certification Program™ encompasses three (3) Certification Training Modules for a total of
sixty (60) hours or ten (10) training days.
The program addresses the application of Software Development Life Cycle (SDLC) to automated Manufacturing and Laboratory systems.
Each participant will be able to understand the rationale within the CSV process and overall, understand “How FDA Thinks” when auditing firm’s CSV, Data Integrity in computerized systems and Part 11 documentation.
Three CSV Certification Training Modules are available to personnel with diverse educational backgrounds.
- MODULE 1: FDA Regulatory Module (6 hours).
- MODULE 2: Development of Validation Documents (42 hours).
- MODULE 3: Documenting CSV QUALITY EVENTS (12 hours).
The certification program is delivered by Johnny Guerra, a former FDA Computer Specialist, ensuring that participants learn all CSV
requirements for the proper detection, correction and prevention of computer and software anomalies that could impact on product quality and validated processes and systems as well.