FDA requires that all documentation related to GxP (GMP, GLC, GCP) products be created and maintained in accordance with specific rules. From the color of the ink used to the FDA labeling requirements, you’ll learn all about how to create and maintain good FDA-compliant documentation.
The webinar will leave you with the information needed to create and maintain good documentation that meets FDA compliance standards. You will learn about what must be done and what must not be done. In addition, you’ll learn about the validation deliverables for computer systems regulated by FDA and how to document them through the entire process.
WHY SHOULD YOU ATTEND
You should attend this webinar if you are responsible for any FDA-regulated data and/or records. All documents need to be created and maintained in accordance with FDA guidelines for good documentation to avoid any issues during an inspection or audit. You will also benefit from learning about the guidelines for computer system validation and the many deliverable documents that need to be produced in a way that is FDA-compliant. Having completed this course, you will be on your way to successful future FDA audits and inspections.
• FDA Good Documentation Practices
• Computer System Validation (CSV)
• System Development Life Cycle (SDLC) Methodology
• GAMPV System Categorization
• Industry Best Practices
• Potential Pitfalls
• To understand how to create, revise and maintain documentation that is FDA-regulated.
• To understand the many deliverables required to complete a computer system validation effort.
• To understand industry best practices.
• To understand and avoid potential pitfalls.
WHO 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
All FDA-regulated industries:
• Medical Device
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