Achieving regulatory compliance and product quality starts with effective verification and validation (V&V). This comprehensive course covers the principles, requirements, and best practices for verifying and validating products, equipment, processes, software, and Quality Management Systems (QMS) in regulated industries such as pharmaceuticals, medical devices, biotechnology, and manufacturing.
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:
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.
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
Agenda
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 4 th , 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
- 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
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
Course Provider
John E. Lincoln,
