Develop/review a company's Master Validation Plan for major cGMP deficiencies. Address the U.S. FDA's newer and tougher regulatory stance. One major failing is 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 key 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 real-world implementation of useful 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 key subject “inputs”
- Compile “generic” Master and Individual Validation Plans
- Lean the key element of a Product V&V File/Protocol
- How to develop Process and/or Production/Test Equipment V&V Files/Protocols
- Basic Test Case/Script construction
- Sample sizes and their justification
- Lean 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
9.0 RAC CREDITS
RAPS - This course has been pre-approved by RAPS as eligible for up to 9 credits towards a participant's RAC recertification upon full completion.
Course Content
Session Start Time: 12:30 PM
- 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 key 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)
05:00 - Day One Wrap-up
Day 2
Session Start Time: 12:30 PM
- 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