Seminar on Verification vs. Validation - Product Process Software and QMS 2017

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. 

At a Glance

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Registration Fee: $$1,295

Date and Location

Thursday, January 12, 2017 - 9:00am to Friday, January 13, 2017 - 6:00pm

Embassy Suites Convention Center Las Vegas
3600 Paradise Road
Las Vegas, NV 89169
United States

Point of Contact

A point of contact has not been selected for this event.

Event Details

Event Size: 
50 - 100 Attendees
Event Type: 
Conference
Website URL: 
Related Sectors: 
Regions : 
Country: 
United States

Full Event Description: 

Course "Verification vs. Validation - Product Process Software and QMS" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
Overview: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.
Why should you 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
Location: Las Vegas, NV Date: January 12th & 13th, 2017 and Time: 09:00 AM to 06:00 PM 
Venue: Embassy Suites Convention Center Las Vegas
             3600 Paradise Road, Las Vegas, Nevada, 89169, USA
Price:
 
Register now and save $200. (Early Bird)
 
Price: $1,295.00 (Seminar Fee for One Delegate)
 
Until December 15, Early Bird Price: $1,295.00 From December 16 to January 10, Regular Price: $1,495.00
 
Register for 5 attendees   Price: $3,885.00   $6,475.00 You Save: $2,590.00 (40%)*
 
Quick Contact:
NetZealous DBA as GlobalCompliancePanel
 
Phone: 1-800-447-9407
Fax: 302-288-6884
Email: support@globalcompliancepanel.com      
Website: http://www.globalcompliancepanel.com
Registration Link - http://www.globalcompliancepanel.com/control/globalseminars/~product_id=...
 
 
Follow us on LinkedIn: https://www.linkedin.com/company/globalcompliancepanel
 
 

Speakers and Agenda: 

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 Speaker: John E Lincoln Consultant, Medical device and Regulatory affairs, John E Lincoln is Principal of J. E. Lincoln and Associates LLC, a consulting company. John, a graduate of UCLA, is a medical device and Regulatory Affairs consultant. He has helped companies to implement or modify their GMP systems and procedures, product risk management and U.S. FDA responses. In addition, he has successfully designed, written and run all types of process, equipment and software qualifications/validations, which have passed FDA audit or submission scrutiny, and have been described in peer-reviewed technical articles and workshops worldwide. John has also managed pilot production, regulatory affairs, product development/design control, 510(k) submissions and risk management per ISO 14971 and implemented projects. With over 28 years of experience in the FDA-regulated medical products industry, he has worked from start-ups to Fortune 100 companies, including Abbott Laboratories, Hospira, and Tyco/Mallinckrodt.

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