Description

Develop/review a company's Master Validation Plan for significant cGMP deficiencies. Address the U.S. FDA's newer and tougher regulatory stance. One major failing is the lack of sufficient or targeted risk-based V&V planning:

• Start with a Master Validation Plan;
• Evaluate its elements against ISO 14971 and ICH Q9 for hazard analysis and product risk management;
• The Individual V&V Plan;
• V&V Project Management;
• “Risk-based” per ISO 14971, ICH Q9, and/or GAMP/JETT;
• Two key input analysis tools;
• Change control and "drawing a line in the sand";
• Develop meaningful V&V Files and Protocols for:
• Products;
• Process;
• Production Equipment;
• Monitoring and Test Equipment;
• Software;
• Quality Management System – 21 CFR 11, Electronic Records / Signatures;
• The roles of different V&V protocols;
• How to employ equipment/process DQs, IQs, OQs, and PQs, or their equivalents,
• V&V against a background of limited company resources;
• The FDA's 11-element software matrix simplifies "as-product," in-product," process and equipment, et al., software VT&V;
• Assure essential U.S.FDA and comparable EU MDD / ISO requirements are not overlooked;
• The QMS and 21 CFR Part 11, "Electronic Records / Signatures" V&V;
• Hands-on examples and activities show the real-world implementation of valuable principles, tools, and templates;

Learning Objectives

• Understand Verification and Validation, differences, and how they work together.
• Develop a "Working Definition" of V&V, Qualification, and related terms
• Discuss recent regulatory expectations
• How to document a "risk-based" rationale and use it in a resource-constrained environment
• Determine key "milestones" and "tasks" in a project; device sample provided
• Locate and document the critical subject "inputs."
• Compile "generic" Master and Individual Validation Plans
• Learn the critical element of a Product V&V File / Protocol
• How to develop Process and Production / Test Equipment V&V Files / Protocols
• Basic Test Case / Script construction
• Sample sizes and their justification
• Learn the key 11 elements of Software V&V expected by the FDA and how to document
• See how to compile QMS Electronic Records and Electronic Signatures V&Vs per 21 CFR 11 and related CGMPs

Agenda

Day 01 || 01:00 PM EST

• Introductions; Housekeeping Announcements; Workbook Walk-Through
• V&V Planning; The Master Validation Plan; The Individual Validation Plan
• Break and Q & A
• "Risk-based" -- Evaluate its elements against ISO 14971 and ICH Q9 for hazard analysis and product risk management – File Narrative, Hazard Analysis, FTA, 3 FMECAs (Design, Process, Use[r], and a possible 4th, Software); also GAMP / JETT approaches
• V&V Project Management – "Milestones" and "Tasks"
• Two essential input analysis tools – The Process Map / Flow Chart and the Cause and Effect Diagram (templates supplied)
• Change control and "drawing a line in the sand."
• Break and Q & A
• Elements of a V&V File / Protocol:
• Intro / Purpose / Scope
• Protocol Material / Equipment
• DQ or Requirements Specs
• ASTM2500
• IQ (or equivalent)
• OQ (or equivalent)
• PQs (or equivalent)

Day 02 || 01:00 PM EST

• Develop and Employ Meaningful V&V Files and Protocols for:
• Products;
• Process;
• Production Equipment;
• Monitoring and Test Equipment;
• Software;
• Quality Management System – 21 CFR 11, Electronic Records / Signature
• The FDA's 11-element software matrix simplifies "as-product," in-product," process and equipment software V&V – what they mean, how to research, and how to document
• The QMS, ERP, and 21 CFR Part 11 V&V – "Cloud" Issues; "White box" and "Black box" Testing; Basic Test Case Development
• V&V, Senior Management / IP and Limited Company Resources
• U.S. FDA Audit Issues and "Responsible" Documentation
• Course Highlights and Q & A

Who will Benefit

This seminar will provide valuable assistance to all regulated companies that need to review and modify their Master Validation Planning and Plan(s). While this information is focused on Medical Devices, its principles apply to personnel/companies in the Pharmaceutical, Diagnostic, and Biologics fields. The employees who will benefit include:

• Senior and middle management and staff
• Regulatory Affairs
• QA/QC
• IT/IS
• R&D
• Production Management
• Manufacturing Engineers
• Process Engineers
• Software Engineers
• Project Managers
• Hardware and software vendors, sales and marketing