Medical Device Non-Product Software Validation Training

Speaker

Instructor: John E Lincoln
Product ID: 706874
Training Level: Intermediate to Advanced

Location
  • 22
  • February 2023
    Wednesday
  • 10:00 AM PST | 01:00 PM EST
    Duration: 90 Min
This presentation focuses on the verification and validation planning and execution of software, used in medical device manufacturing, after basic developmental testing and de-bug. It includes COTS (commercial off-the-shelf), custom, and the growing field of "cloud"-based software. A suggested FDA model (mandated for submissions) will be evaluated, implemented, with V&V documentation and test case examples. The focus is on the most recent issues the FDA has had in this area, and remediation approaches. Software considered: 1) Production / Test, and 2) QMS / 21 CFR Pt. 11, and 3) Cybersecurity / Networked systems. Examples will be demonstrated. Evaluation of the chief areas of FDA concerns will focus on actual and anticipated changes in emphasis based on the changing regulatory climate.
LIVE ONLINE TRAINING

February 22, Wednesday 10:00 AM PST | 01:00 PM EST
Duration: 90 Min

 

$199.00
One Dial-in One Attendee

$999.00
Group-Max. 10 Attendees/Location
(For multiple locations contact Customer Care)

$349.00

$399.00

$249.00
1 Person Unlimited viewing for 6 month info Recorded Link and Ref. material will be available in My CO Section 48 hrs after completion of Live training
(For multiple locations contact Customer Care)

$299.00
Downloadable file is for usage in one location only. info Downloadable link along with the materials will be emailed within 2 business days after completion of Live training
(For multiple locations contact Customer Care)

 

 

Customer Care

Fax: +1-650-362-2367

Email: [email protected]

Read Frequently Asked Questions

Why Should You Attend:

Software design, development, implementation and use is under increased scrutiny by a "tougher" U.S. FDA. Software V&V issues are becomming a growing area of concern by regulatory agencies. Product production / test equipment, and even the QMS are heavily software / firmware driven in today's manufacturing. Part 11 and cybersecurity are often important considerations. A comprehensive, corporate wide plan is a necessity. Growing "cloud" issues add urgency to upgrade control. Software's complex logic pathways mandate resourse-intensive V&V activities, in a resource-constrained environment, demanding a risk-based approach. What are the best approaches for companies to take? How can tougher expectations be met? What V&V is necessary to minimize software failures? Use the FDA's own "model" to document all types of SW V&V. And use this model to add predictability to bring software V&V in under budget and within project timelines.

Areas Covered in the Webinar:

  • Major areas of industry failure
  • Tougher FDA Expectations / Requirements; Cybersecurity
  • Roles of Verification and Validation
  • An FDA "Model"
  • A Typical Software V&V Protocol / Test Report; "Black" and "White" box
  • A Brief Overview of 21 CFR Part 11, and its implementation
  • Legacy, Hybrid, New and ER / ES Systems
  • Expected Regulatory Deliverables
  • Cybersecurity

Who Will Benefit:

This webinar will provide valuable assistance to all regulated companies in evaluating their existing or anticipated device production software / firmware V&V activities and documentation requirements, especially in light of the changes in the FDA's stance vis a vis industry compliance, past problems, and the growing "cloud" environment. It will help attendees understand and recognize the most common software V&V failings and their fixes. The webinar will allow attendees to develop and use a repeatable software V&V template for all software produiction equipment and process validation projects. This information applies to personnel / companies in the Medical Device and some Combination fields. The employees who will benefit include:

  • Senior management
  • Regulatory Affairs
  • Quality Assurance / QAE
  • Production
  • Engineering, R&D, and software development and testing teams
  • All personnel involved in a U.S. FDA-regulated environment. Especially those involved in new product development with products and productioin / test equipment that are software driven, companies with quality management / MRP / ERP systems moving toward "paperless" systems, or other regulated medical products / CGMP and ISO QMS activities.
Instructor Profile:
John E Lincoln

John E Lincoln
Principal, J E Lincoln and Associates

John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 41 years experience in U.S. FDA-regulated industries, 27 years as head of his own consulting company. John has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment including QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files. He's held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D). In addition, John has prior experience in military, government, electronics, and aerospace. He has ptublished numerous articles in peer reviewed journals, 5 chapters in the RAPS textbook on validation, conducted workshops and webinars worldwide on CGMP subjects. John is a graduate of UCLA.

Follow us :

 

 

Refund Policy

Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).

 

 

+1-888-717-2436

6201 America Center Drive Suite 240, San Jose, CA 95002, USA

Follow Us

facebook twitter linkedin youtube

 

Copyright © 2021 ComplianceOnline.com MetricStream
Our Policies: Terms of use | Privacy

PAYMENT METHOD: 100% Secure Transaction

payment method