cybersecurity-for-devices-and-cgmp-e-systems

Cybersecurity for Devices and CGMP E-Systems

Live Webinar

  • 60 minutes

Data Integrity, and especially cybersecurity, is a growing concern for all – legal, financial, consumer, personal, and …Cybersecurity is a recent concern for the medical products industries, a result of their increased reliance on networked electronic software, records and signatures. 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. Cybersecurity is an issue that will only increase over time, as records become more electronic, and communications are more networked or accessible.

Cybersecurity in the medical products industries is coming under increased regulatory review. Regulatory agencies leave the how of cybersecurity compliance up to the manufacturer, as long as the principles in the guidance’s are met in the resulting product and/or system. Related issues are primarily addressed by the CGMPs, specifically design control (21 CFR 820.30) for devices, and post-production by the CAPA system, among others.

Join this session with expert speaker John E. Lincoln, where he will discuss about the Cybersecurity and CGMP E-System and some highly important topics in detail. Also, he will talk about Validation/ Revalidation, Authentication, security risks. This webinar focuses on devices, but also discusses company computerized systems, related potential problems with an e-records based QMS, computer-facilitated production and/or test / lab equipment / systems.

Session Highlights:

This webinar will cover the following topics.

  • Explosive BYOD growth and issues

  • Security risks

  • Identify and Protect

  • Authentication

  • Detect, Respond, Recover

  • Detect, Respond, Recover

  • Patches

  • Lifecycle

  • Validation / Revalidation

  • FDA Submission and Inspection Requirements/ Concerns

Why You Should Attend:

This webinar will give you a brief about cybersecurity of Devices, as in today’s world Medical devices are increasingly connected to the Internet, hospital networks. These same features also increase the risk of potential cybersecurity threats. So it is important to understand about cybersecurity and CGMP E-Systems. This webinar focuses on devices, but also discusses company computerized systems, related potential problems with an e-records based QMS, computer-facilitated production and/or test / lab equipment / systems.

Who Should Attend :

  • Senior and Middle Management

  • Research and Development

  • Quality Assurance / Quality Control

  • Regulatory Affairs

  • Manufacturing

  • Production

  • Engineering

  • Operations

  • Purchasing Medical products consultants



You may ask your Question directly to our expert during the Q&A session.

** You can buy On-Demand and view it as per your convenience.

John Lincoln

John Lincoln

John E. Lincoln, consultant, J. E. Lincoln and Associates LLC, has successfully designed and implemented complete 21 CFR 210, 211, 820 and ISO 13485 quality management systems, which have passed FDA audits, and described in peer-reviewed technical articles and workshops, worldwide. John has also set up and managed pilot production, regulatory affairs, product development / design control projects. He has over 38 years of experience, 24 years as an independent consultant, with medical products and regulatory affairs – working with start-ups to Fortune 100 companies, including Abbott Laboratories, Hospira, Tyco / Mallinckrodt. John has served on the Reader and Editorial Review Boards of MDDI Magazine and the Journal of cGMP Compliance. He is a graduate of UCLA.

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