Description

This webinar will discuss recently implemented US FDA requirements and some headng into 2027. There's the recently introduced QMSR, (with ISO 13485 included by reference). Major emphasis will be upon risk management in accordance with ISO 14971:2019, which in the old 820 only had casual reference  in 820.30. The FDA views risk management as an “essential systematic practice” to ensure that devices are safe and effective. Some parts of ISO 13485 are emphasized, explained in 820, Subparts A and B, to meed legal requirement of the FD&C Act. There are other changes, and how this is beginning to change FDA inspectioins based on recent observations and as outlined in the FDA's new Device Inspection Manual.

There will be more use of virtual ispections forpart or all of both drug and devices,  which will also be discussed during this webinar. FDA inspections are not a substitute for an ISO 13485 certification audit if one is required, nor would those who hold an ISO 13485 Notified Body audit certificate be exempt from FDA inspection. FDA will now inspect a company's CGMP Self Audit findings and their annual Management Review minutes and findings.

Cybersecurity and ML/AI continue to receive growing FDA attention in inspections and submissions. The use of AI in drug development are getting the FDA's new Guidline, developed in cooperation with the EU. Are device manufacturers taking advantage of the PCCP requirements for marketing submissions which will reduce the reguirements for new submissions for previously anticipated changes, especially for AI device functions.

Areas Covered in the Session:-

• Introduction to the QMSR
• Incorporation by reference ISO 13485
• Increased emphasis on product risk management
• US FDA's New  Device Inspection Manual
• New Requirements for Device Human Factors / Use Engineering
• The FDA's (and EU's) New AI in Drug Development Guidelines, 10 Principles
• Other Drug and Device Guidelines and Expectations.

Background:-

2026 saw major change in the FDA Medical Device regulatory requirements. AI in Drug Development also got attention. More parial or complete virtual inspections. What can we expect in 2027.

Why Should You Attend:-

The FDA has been working to align its QSR with worldwide QMS standard ISO 13485 resulting in the new 21 CFR 820, the QMSR replacing the QSR. A new FDA Device Inspection Manual, 7382.850 was also released, with an increased focus on patient / user risk management in devices and throughout the QMS. Companies are just now starting to see how this is translating to practical requirements in the field. Continued review / removal of the lab test device marketing authorization "loophole".  FDA just introduced their requirement for human factors / use enginering analysis and categorization for device submissions.

AI has driven the recerntly implemented PCCP requirement for device marketing submissions.   AI and cybersecurity continue to receive the Agency's attention for Drugs and Devices.  The FDA, working with Europe, has published the 10 Guidelines for use of AI in drug development.  Prescription Drug Use, Biosimilars, tightened Compounding requirements, and Clinical Trial data considerations are some recent FDA Guidance Document subjects.

Who Should Attend:-

• Senior management in Drugs, Devices, Combination Products
• QA / RA
• Medical Device product development teams
• R&D
• Engineering
• Production
• Operations
• Marketing
• Consultants; others tasked with device QA, product development, manufacturing, process / product / data analysis,  regulatory submission responsibilities.