documenting software for fda submissions
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This document outlines a 2-day in-person seminar on documenting software for FDA submissions, led by Brian Shoemaker in Washington, DC, with a registration price of $1,295. The seminar aims to bridge agile methods and regulatory documentation requirements, addressing key concerns such as documentation, risk management, and compliance with both business and regulatory standards. Participants will receive a seminar kit, certificates, and potential discounts on future events and services.
documenting software for fda submissions
- 1. 2-day In-person Seminar: Knowledge, a Way Forward… Documenting Software for FDA Submissions Washington, DC 9:00 AM to 6:00 PM Brian Shoemaker Price: $1,295.00 (Seminar for One Delegate) Register now and save $200. (Early Bird) **Please note the registration will be closed 2 days (48 Hours) prior to the date of the seminar. Price Overview : Global CompliancePanel Brian Shoemaker consults for healthcare products companies on computer system validation, software quality assurance, and electronic records and signatures. He has conducted validation both on product software and on internal software, developed software quality systems, audited software quality processes (including agile methodology), and evaluated 21 CFR Part 11 compliance. He has had clients in clinical diagnostics, medical device engineering, medical imaging, medical-device fabrics manufacturing, contract lyophilization, clinical trial software, dental prosthetics, and bone-repair implants. When medical device companies consider Agile development methods, they often run into the key criticism that Agile groups produce little to no documentation, and that Agile stands in contradiction to the lifecycle standards outlined in IEC 62304. In fact, those principles - have clear processes for quality management system, risk management process, software maintenance, configuration management, and problem resolution - actually augment rather than contradict the Agile manifesto. The Agile approach helps companies avoid hearing bad news late in a project, by delivering incrementally, integrating regularly, and leaving room for learning as the user stories are refined. In addition, it provides real information on progress and project speed to stakeholders outside the development group. $6,475.00 Price: $3,885.00 You Save: $2,590.0 (40%)* Register for 5 attendees August 10th & 11th, 2017 FDA Submissions
- 2. 2-day In-person Seminar: Documenting Software for FDA Submissions Agenda: Day One Day Two Lecture 1: Are Agile and medical device standards contradictory? Global CompliancePanel Lecture 2: What is the value of documentation? Lecture 3: What do the regulatory bodies require? Lecture 4: Consider the software documentation required for an FDA submission Lecture 1: Where do most companies get bogged down? Lecture 2: Iteration works well for risk, usability and design reviews Lecture 3: Practices are the bridge Lecture 4: The core values align Why you should attend: Agile methods are appearing more and more in regulated health-related applications. The teams carrying out this development must work both rapidly and flexibly, since they are obligated to satisfy not only their business management, but also the patients and caregivers, and, of course, the regulatory bodies who must approve their products. Teams must document all aspects of their development - requirements, design, tests, hazard analysis, usability, and traceability. How do we achieve all that and remain Agile? Many companies struggle with meeting all these expectations; software-related product recalls and failed companies are the legacy of traditional, sequential methods. How can we gather these as development proceeds, while minimizing overhead? How can we assure that inputs are reviewed and approved, without getting mired in the document signoff spiral? How can we address design reviews without bogging down the team in long, droning meetings? How can we capture traceability as a natural outcome of our work? Experience is showing, and the AAMI Agile report (TIR 45) has stated, that when Agile is properly applied in the context of a quality system and robust safety risk management, its emphasis on nimbleness and ongoing learning can be reconciled with regulatory expectations of well-documented development. Documenting Software for FDA Submissions
- 3. www.globalcompliancepanel.com Kindly get in touch with us for any help or information. Look forward to meeting you at the seminar GlobalCompliancePanel What You will get Special price on future seminars by GlobalCompliancePanel. Networking with industry's top notch professionals 7 9 1 Learning Objectives 2 Participation certificates Interactive sessions with the US expert Post event email assistance to your queries. Special price on future purchase of web based trainings. Special price on future consulting or expertise services. 3 4 5 6 Seminar Kit – includes presentation handout, ID card, brochure, trainings catalog, notepad and pen. 8 Contact Information: Event Coordinator NetZealous LLC, DBA GlobalCompliancePanel 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA Toll free: +1-800-447-9407 Fax: 302 288 6884 Email: support@globalcompliancepanel.com 10% 20% 25% 30% 2 Attendees to get offer 3 to 6 Attendees to get offer 7 to 10 Attendees to get offer 10+ Attendees to get offer Group Participation Payment Option 1 Credit Card: Use the Link to make Payment by Visa/Master/American Express card click on the register now link 2 Check: Kindly make the check payable to NetZealous DBA GlobalCompliancePanel and mailed to 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA PO: Please drop an email to support@globalcompliancepanel.com or call the our toll free +1-800-447-9407 for the invoice and you may fax the PO to 302 288 6884 Wire Transfer: Please drop an email to support@globalcompliancepanel.com or call our toll free +1-800-447-9407 for the wire transfer information 3 4 Global CompliancePanel 2-day In-person Seminar: Documenting Software for FDA Submissions