Master Validation Planning To Meet U.S. FDA cGMP, ISO 13485, and ICH Q9 / ISO 14971 Requirements

$299.00

Description:

The U.S. FDA released a new guidance document on wireless medical devices, “Radio Frequency Wireless Tehnology in Medical Devices”, on August 13, 2012. Its purpose is to address the growing use of wireless technology in medical devices in support of health care and new avenues for risk, such as signal interference / interruption.

FDA stated: “It is essential that manufacturers first consider and test potential limitation of the wireless connectivity associated with their devices to prevent manfunctions that could harm patients.”

This is a relatively new, but growing field. Our instructor, a renown industry expert, John E. Lincoln has regulatory experience in wireless devices and has prepared two such 510(k)s. He recently published a journal article on this new guidance. In this webinar he will also discuss the consideration of the FDA’s concerns over which device functions could be made wireless, and which should employ wired connectivity.

Areas to be Covered:

The Guidance focuses on two areas, as will this webinar:
Considerations for Design, Testing and Use of Wireless Medical Devices
Recommendations for Premarket Submissions for Devices that Incorporate RF Wireless Technology.
Security issues and electromagnetic compatibility (EMC).
The risk-based approach to verification and validation of such devices
Unique labeling requirements

Who will Benefit:

This webinar will provide valuable assistance to all regulated companies that are or anticipate having products in this growing market. Its principles apply to personnel / companies primarily in the Medical Devices fields. The employees who will benefit include:
Senior management
Middle management
R&D
Engineering
Software
QA / RA
Manufacturing
Operations
Consultants
cGMP instructors
All personnel involved in design, development, manufacture, verification and/or validation planning, execution and documentation for such devices

John E. Lincoln

John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 36 years experience in U.S. FDA-regulated industries, 22 of which are as an independent consultant. 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 QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files, CAPA systems and analysis.

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 published numerous articles in peer reviewed journals, conducted workshops and webinars worldwide on CAPA, 510(k)s, risk analysis / management, FDA / GMP audits, validation, root cause analysis, and others. He writes a recurring column for the Journal of Validation Technology. John is a graduate of UCLA.

$299.00

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  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance