Seminar on Verification vs. Validation - Product Process Software and QMS

Overview:

This course will review the company Master Validation Plan for major key inputs and CGMP deficiencies. It will address the FDA's newer & 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, & 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.

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.

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

QA/QC

IT/IS

R&D

Production Management

Manufacturing Engineers

Process Engineers

Software Engineers

Project Managers

Hardware and software vendors, sales and marketing

Any professional tasked with V&V responsibilities

Agenda:

Day 1 Schedule:

Lecture 1:

Master Validation Planning and the Master Validation Plan(s)

Lecture 2:

Product, Process / Equipment Hardware V&V

Lecture 3:

Product / Device V&V

Lecture 4:

Software V&V

Lecture 5:

Quality Management System / 21 CFR Part 11 V&V

Lecture 6:

Summary of morning discussion

Lecture 7:

Group activity on the MVPs

Lecture 8:

Review of group activity and Q&A

Day 2 Schedule:

Lecture 1:

Software V&V documentation "model"

Lecture 2:

Software V&V protocols - "black box", "white box"

Lecture 3:

Electronic Records and Electronic Signatures (Part 11)

Lecture 4:

Summary of morning discussion

Lecture 5:

Group activity on 1) hardware / equipment, and 2) software V&V protocols

Lecture 6:

Review of group activity and Q&A

Lecture 7:

Course summary discussion

Lecture 8:

Summary of morning discussion

Lecture 9:

Group activity on the MVPs

Lecture 10:

Review of group activity and Q&A

Contact Information:

NetZealous LLC,

DBA GlobalCompliancePanel

161 Mission Falls Lane,

Suite 216, Fremont, CA 94539, USA         

USA Phone: 800-447-9407

Fax: 302-288-6884

support@globalcompliancepanel.com  

http://www.globalcompliancepanel.com