Cybersecurity - The Latest US FDA Requirements

Cybersecurity is the art of protecting networks, devices, and data from unauthorized access or criminal use. It is the practice of ensuring confidentiality, integrity, and availability of information, and is a rapidly growing problem for industry. 

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Last Recorded Date: Jan-2024

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Description

Cybersecurity is a recent concern for medical products, due to the increased reliance on electronic software, records and signatures, stand-alone or networked.

Initially there were regulations such as 21 CFR Part 11 in the U.S. and Annex 11 in Europe. But more must be done to ensure the integrity of CGMP documents / records / data. As a result, the US FDA issued sveral Guidance Documents on cybersecurity - which are constantly undergoing updates to keep up. Regulatory agencies leave the specifics up to the manufacturer, as long as the principles in the guidances are addressed. The U.S. FDA has increasingly observed CGMP violations involving cybersecurity during CGMP compliance inspections, device submissions, and in security breaches related to medical device use. Adding to the problem is BYOD – “Bring Your Own Device”(laptop, tablet, smart phone, or other “smart” device) to the workplace. These growing trends pose problems to the integrity and security of data. The increasing use of cloud (Internet)-based software to accomplish CGMP tasks, store / retrieve data (data warehousing) and similar uses poses additional problems.

Why Should You Attend:

Due to the growth of the cybersecurity threat to electronic records, computer-controlled manufacturing, and medical devices, the US FDA has issued Guidances for Industry, e.g.:  1) “Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software Document”, and 2) “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices” - recently updated, and 3) “Postmarket Management of Cybersecurity in Medical Devices” . This webinar will focus on the key issues raised by the FDA, not just for devices, but expectations for industry. Cybersecurity in the medical products industries is coming under increased regulatory review. The Agency leaves the how of cybersecurity compliance up to the manufacturer, as long as the principles in the guidances are met in the resulting product and/or system; and on electronic-specific tools / techniques to achieve CGMP compliance . Updates, upgrades, new revisions / releases, service packs, and similar are automatically uploaded to a company’s systems, which can pose security risks, with the potential for introduction of compromised code, retrieval of confidential data, data integrity issues, and similar; and render previous computer systems’ verification and validations worthless. The necessary role of the system administrator adds another area of concern.  This webinar will consider how cybersecurity is introduced into the CGMPs, design control (21 CFR 820.30) for devices, and post-production by update, the CAPA system, among others.

Areas Covered in the Webinar:
  • Key Guidance Documents on Cybersecurity - and recent changes
  • FDA’s enforcement approaches
  • Network vunerablities issues
  • Cloud, updates and other concerns
  • FDA’s regulatory approach; Examples
  • Design, security tools and other requirements
  • NIST and related cybersecurity considerations
  • Verification, validation and unique documentation requirements
  • FDA unique device submission requirements
Who Will Benefit:
  • Senior management in Devices, Combination Products
  • QA / RA
  • Software development, programming, documentation, testing teams
  • R&D
  • Engineering
  • Production
  • Operations
  • Marketing
  • Consultants; others tasked with product, process, electronic records software V&V responsibilities
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 36 years’ experience in U.S. FDA-regulated industries, 22 as a full-time 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 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 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. John is a graduate of UCLA.

Refund Policy

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. FDATrainingAlert 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.

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