Course Agenda:
The FDA has new and tougher regulatory requirements for a companys Master Validation Plan for major key inputs and CGMP deficiencies. This seminar will address these. It seeks to demonstrate "Product Risk Based V&V" by sufficient, targeted and documented risk-based V&V test case elements/scripts. It will help participants evaluate these elements against ISO 14971 and ICH Q9 for hazard analysis and product risk management.
In arriving at its goal, this seminar will evaluate aspects such as 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,software VT&Vet al, all to make sure that key FDA requirements are not overlooked. This course will alsoconsider QMS and 21 CFR Part 11, whose practical application will be made during the two days of interactive training.
---------------------------------------------------------------------------------------------------------------------
Course Description:
Day 1 - 17th January 2013
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 - 18th January 2013
Lecture 9: Software V&V documentation "model"
Lecture 10: Software V&V protocols - "black box", "white box"
Lecture 11: Electronic Records and Electronic Signatures (Part 11)
Lecture 12: Summary of morning discussion
Lecture 13: Group activity on 1) hardware/equipment, and 2) software V&V protocols
Lecture 14: Review of group activity and Q&A
Lecture 15: Course summary discussion
Lecture 16: Summary of morning discussion
Lecture 17: Group activity on the MVPs
Lecture 18: Review of group activity and Q&A
---------------------------------------------------------------------------------------------------------------------
Purpose of the seminar
This session helps participants:
oUnderstand Verification and Validation, differences and how they work together;
oDiscuss recent regulatory expectations;
oKnow how to document a "risk-based" rationale, and use it in a resource-constrained environment;
oDetermine key "milestones" and "tasks" in a project;
oLocate and document key subject "inputs";
oCompile "generic" Master and Individual Validation Plans;
oLearn the key element of a Product V&V File/Protocol;
oUnderstand how to develop Process and/or Production/Test Equipment V&V Files/Protocols;
oGet a grasp of basic Test Case construction;
oUnderstand sample sizes and their justification;
oLearn the key elements of Software V&V expected by the FDA and how to document;
oDeal with hardware and software vendors, sales and marketing
oConsider a field-tested software V&V documentation "model";
oSee how to compile QMS Electronic Records and Electronic Signatures V&Vs to satisfy 21 CFR Part 11.
---------------------------------------------------------------------------------------------------------------------
About the Speaker:
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.
---------------------------------------------------------------------------------------------------------------------
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:
oSenior and middle management and staff
oRegulatory Affairs
oQuality Assurance or Quality Control Professionals
oQA/QC
oIT/IS
oR&D
oProduction Management
oManufacturing Engineers
oProcess Engineers
oSoftware Engineers
oProject Managers
oHardware and software vendors, sales and marketing
oAny professional tasked with V&V responsibilities
DATE AND VENUE:
January 17 and 18, 2013
Seminar Timings: 9am to 6pm EST
Venue:Hilton Grand Vacations Suites at the Flamingo
Address: 3575 Las Vegas Boulevard South, Las Vegas, Nevada, 89109
Price $ 1495;
Group discounts available in the following pattern:
Send two attendees: Get a discount of 10%
Send three to six attendees: Get a discount of 20%
Send seven to 10 attendees: Get a discount of 25%
Send 10 attendees or more off: Get a discount of 30%
To avail the above group discounts, all the participants should register by making a single payment.Please contact Customer Care at 1800 447 9407
---------------------------------------------------------------------------------------------------------------------
Contact Information:
Event Coordinator
Toll free: 1800 447 9407
Fax: 302 288 6884
Email: [email protected]
Website:https://www.globalcompliancepanel.com/
GlobalCompliancePanel
NetZealous
USA Livermore Common, Fremont,
CA 94539, USA
Phone: 1800 425 9407