Software and QMS 2018 - Verification vs. Validation - Product Process Software and QMS 2018

Verification vs. Validation - Product Process Software and QMS 2018
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 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
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.
Location: St. George UT Date: January 22nd & 23rd, 2018 and Time: 9:00 AM to 6:00 PM
Venue: WILL BE ANNOUNCED SOON
Price:
Price: $1,295.00 (Seminar Fee for One Delegate)
Register now and save $200. (Early Bird)
Until January 01, Early Bird Price: $1,295.00 From December 31 to January 20, Regular Price: $1,495.00
Register for 5 attendees Price: $3,885.00 $6,475.00 You Save: $2,590.00 (40%)*
Register for 10 attendees Price: $7,122.00 $12,950.00 You Save: $5,828.00 (45%)*
Sponsorship Program benefits for “Quality Assurance Auditing for FDA Regulated Industry” seminar
At this seminar, world-renowned FDA Regulated Industry subject matter experts interact with CXO’s of various designations. Executives who carry vast experience about FDA Regulated Industry and Experts get down to discussing industry-related best practices, regulatory updates, changes in technologies, and much more relating to FDA Regulated Industry.
As a sponsor of these seminars, you get the opportunity to have your product and company reach out to C-Level executives in FDA Regulatory -related industries and become known among these elite executives and subject matter experts. Apart from being seen prominently at these globally held seminars, you also get talked about frequently in our correspondences with our experts and these participants.
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