This course will review the company Master Validation Plan for major key inputs and CGMP deficiencies. It will address the FDA's newer and tougher regulatory stance. This course's aim is to prove "Product Risk Based V&V" by sufficient, targeted and documented risk-based V&V test case elements/scripts. It will teach participants to evaluate its elements against ISO 14971 and ICH Q9 for hazard analysis and product risk management.
This course will evaluate different field-tested, U.S. FDA-reviewed V&V protocols; how to employ equipment/process Requirements Specs / DQs, IQs, OQs, and PQs, or their equivalents per ASTM E2500, all against a background of limited company resources.
It will review a matrix that simplifies "as-product", in-product", process and equipment, et al, software VT&V, to assure key FDA requirements are not overlooked. While considering the QMS and 21 CFR Part 11; this course will make practical application of these same in two hands-on sessions.
Who Will Benefit:
This workshop will provide valuable assistance to all regulated companies that need to review and modify their Master Validation Planning and V&V activities / plan(s). This information addresses Medical Devices, Pharmaceutical, Diagnostic, and Biologics requirements and implementation. The employees who will benefit include:
- Senior and middle management and staff
- Regulatory Affairs
- Quality Assurance or Quality Control Professionals
- Production Management
- Manufacturing Engineers
- Process Engineers
- Software Engineers
- Project Managers
- Hardware and software vendors, sales and marketing
- Any professional tasked with V&V responsibilities
Why you should attend:
This session helps participants:
- Understand Verification and Validation, differences and how they work together;
- Discuss recent regulatory expectations;
- Know how to document a "risk-based" rationale, and use it in a resource-constrained environment;
- Determine key "milestones" and "tasks" in a project;
- Locate and document key subject "inputs";
- Compile "generic" Master and Individual Validation Plans;
- Learn the key element of a Product V&V File/Protocol;
- Understand how to develop Process and/or Production/Test Equipment V&V Files/Protocols;
- Get a grasp of basic Test Case construction;
- Understand sample sizes and their justification;
- Learn the key elements of Software V&V expected by the FDA and how to document;
- Deal with hardware and software vendors, sales and marketing
- Consider a field-tested software V&V documentation "model";
- See how to compile QMS Electronic Records and Electronic Signatures V&Vs to satisfy 21 CFR Part 11.