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 you should attend:
1. This session helps participants:
2. Understand Verification and Validation, differences and how they work together;
3. Discuss recent regulatory expectations;
4. Know how to document a "risk-based" rationale, and use it in a resource-constrained environment;
5. Determine key "milestones" and "tasks" in a project;
6. Locate and document key subject "inputs";
7. Compile "generic" Master and Individual Validation Plans;
8. Learn the key element of a Product V&V File/Protocol;
9. Understand how to develop Process and/or Production/Test Equipment V&V Files/Protocols;
10. Get a grasp of basic Test Case construction;
11. Understand sample sizes and their justification;
12. Learn the key elements of Software V&V expected by the FDA and how to document;
13. Deal with hardware and software vendors, sales and marketing
14. Consider a field-tested software V&V documentation "model";
15. See how to compile QMS Electronic Records and Electronic Signatures V&Vs to satisfy 21 CFR
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:
1. Senior and middle management and staff
2. Regulatory Affairs
3. Quality Assurance or Quality Control Professionals
7. Production Management
8. Manufacturing Engineers
9. Process Engineers
10. Software Engineers
11. Project Managers
12. Hardware and software vendors, sales and marketing
13. Any professional tasked with V&V responsibilities
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
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
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.
Location: Las Vegas NV
Date: 27th & 28th, March 2014
Time: 9 AM to 6 PM
Venue: Hilton Grand Vacations Suites at the Flamingo
Address: 3575 Las Vegas Boulevard South, Las Vegas, Nevada, 89109-4313
Price: $1295.00 (Seminar for One Delegate)
Discount: Register now and save $200. (Early Bird)
Until January 15, Early Bird Price: $1,295.00, From January 16 to March 25, Regular Price: $1,495.00
Get fabulous discounts by participating in groups of two or more.
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Fax: 302 288 6884
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