My Roles and Responsibilities with JAF Consulting Inc. expand in the following areas:
Regulatory Compliance Support:
Interpreting FDA regulations, such as 21 CFR Part 11, Part 210/211, and Part 820, and helping ensure your validation activities meet these requirements.
Supporting preparation for FDA audits by reviewing documentation and identifying gaps.
Validation Process Assistance:
Assisting with drafting and reviewing validation documentation, including IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification) protocols.
Providing input on creating validation master plans and test scripts to ensure thorough coverage of systems or processes.
Quality Documentation:
Reviewing or helping draft SOPs, and risk management plans.
Ensuring documents align with both internal standards and regulatory expectations.
Data Integrity & Systems Compliance:
Offering guidance on data integrity principles, particularly around ALCOA+ (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available).
Evaluating systems for Part 11 compliance, focusing on electronic records and signatures.
Audit Readiness & Gap Analysis:
Assisting in mock audits to assess validation processes and documentation readiness.
Conducting or supporting gap analyses against FDA guidance and industry best practices.
Computer Systems Validation, Equipment Validation, and Manufacturing Systems commissioning and qualification.
Client Satisfaction and JAF Team Appreciation.
Rhode Island
India and the United States
Accuracy: Providing reliable, detailed, and precise information to ensure your work aligns with regulatory and quality standards.
Integrity: Upholding transparency and honesty in the guidance and resources I offer, ensuring compliance with ethical and regulatory principles.
Collaboration: Partnering with you to understand your specific needs, challenges, and goals, so my support is practical and relevant.
Adaptability: Tailoring solutions and approaches to fit the unique demands of your projects, whether drafting a validation plan or troubleshooting compliance issues.
Continuous Improvement: Staying updated on regulatory trends and best practices to ensure the information and tools I provide are current and effective.
Accountability: Taking responsibility for the accuracy and utility of my contributions, ensuring they add value to your processes.
Writing, Pickleball, Volleyball, Cricket (analysis)
I volunteer at a local Cat Sanctuary.
