Effective and compliant computer system validation is critical to any pharmaceutical or FDA-regulated organization.  During the past 30 years, best practices that have been developed will ensure that validation activities are cost-effective while meeting all aspects of FDA compliance.

While these practices have been employed, companies are being forced to do more work with fewer resources, leading to errors noted in citations, particularly in Warning Letters in the past 10 years.  This has resulted in consequences including heavy fines and operational shut-downs.

Both FDA and industry recognize the need to review current practices to ensure they meet the standards for creating data with integrity and maintaining it as such throughout the entire life cycle.  In this webinar, you will learn about these FDA trends in compliance and enforcement, as they relate to data integrity, and how to improve your practices to meet compliance requirements.

Course Objectives:

• Discuss the best practices necessary to ensure all systems are validated appropriately
• Learn how to develop the appropriate computer validation strategy, to ensure a good balance of cost vs. risk
• Understand how to effectively document the process of computer system validation, and maintain current information about the various systems in your organization and how they are maintained in a validated state
• Learn how to develop a strategic approach to data governance to ensure data integrity, quality, identity, accessibility, and security

Why Should You Attend:

After attending this course, you will understand data governance as a quality control discipline for assessing, managing, using, improving, monitoring, maintaining, and protecting organizational information.  It is a system of decision rights and accountabilities for information-related processes, executed according to agreed-upon models which describe who can take what actions with what information, and when, under what circumstances, and, finally, using what methods.

Course Outline:

• Computer System Validation (CSV)
•  System Development Life Cycle (SDLC) Methodology
•  Good “Variable” Practice (GxP) (Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), Good Clinical Practice (GCP))
•  Data Integrity (DI)
•  Validation Strategy, Planning and Execution
•  System Risk Assessment
•  GAMP 5 “V” Model and Software Categorization
•  21 CFR Part 11, FDA’s Guidance on Electronic Records/Electronic Signatures (ER/ES)
•  Security, Access, Change Control and Audit Trail
•  Criteria required to ensure data is created and maintained with integrity through its life cycle
• Policies and Procedures to support CSV and DI assurance
• Training and Organizational Change Management
•  Current FDA Trends in Compliance and Enforcement
•  Industry Best Practices and Common Pitfalls

What You Get:

• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points

Who Will Benefit:

• Information Technology (IT) Analysts
• IT Developers
• IT Support Staff
• QC/QA Managers and Analysts
• Clinical Data Managers and Scientists
• Analytical Chemists
• Quality Managers, Chemists and Microbiologists
• Compliance Managers and Auditors
• Lab Managers and Analysts
• Automation Analysts
• Computer System Validation Specialists
• GMP Training Specialists
• Business Stakeholders using Computer Systems regulated by FDA
• Regulatory Affairs Personnel
• Consultants in the Life Sciences and Tobacco Industries