fda enforcement inspections,trends q&a session with a recent fda investigator
Post on 29-Jun-2015
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Slide 1 of 13
Rob Packard, Presidentwww.MedicalDeviceAcademy.com
rob@13485cert.com
FDA Enforcement Inspections, Trends:
A Q&A Session with a formerFDA Investigator
Slide 2 of 13
Rob Packard, Presidentwww.MedicalDeviceAcademy.com
rob@13485cert.com
Our Speaker
• http://bit.ly/FDA-recalls• http://bit.ly/Lead-Auditor-Course
leo.lagrotte@icloud.com
+1.941.920.2645
Leo J. LagrotteFormer ORA Investigator
Slide 3 of 13
Rob Packard, Presidentwww.MedicalDeviceAcademy.com
rob@13485cert.com
Question #1:You worked in the Tampa, FL office. My clients in the area mentioned that the office makes more regular visits than the target of 2 years. California seems to be another market with almost annual visits. Other regions have inspections less frequently that 2 years. Can you explain why Tampa and California are more frequent than the target of 2 years?
Slide 4 of 13
Rob Packard, Presidentwww.MedicalDeviceAcademy.com
rob@13485cert.com
Question #2Yesterdays’ presentation was about FDA recalls. If a manufacturer has a recall, should an inspection automatically be expected the following year? If not, what other factors impact the likelihood of an inspection?
Slide 5 of 13
Rob Packard, Presidentwww.MedicalDeviceAcademy.com
rob@13485cert.com
Question #3What’s the most common mistake you noticed in companies managing FDA inspections? How do you rectify it?
Slide 6 of 13
Rob Packard, Presidentwww.MedicalDeviceAcademy.com
rob@13485cert.com
Question #4What direction do you think FDA enforcement will take over the next 5 years related to Quality System inspections?
Slide 7 of 13
Rob Packard, Presidentwww.MedicalDeviceAcademy.com
rob@13485cert.com
Question #5Due to industry regulatory compliance trends, are FDA investigators receiving specific new training in QS areas that they have not received in the past?
Slide 8 of 13
Rob Packard, Presidentwww.MedicalDeviceAcademy.com
rob@13485cert.com
Question #6I hear more each year about the “eFDA”--or the automation of administrative tasks at the FDA. Do you think the FDA will ever switch from green and black bound notebooks to electronic devices such as tablets? Could this include photos?
Slide 9 of 13
Rob Packard, Presidentwww.MedicalDeviceAcademy.com
rob@13485cert.com
Question #7The Medical Device Single Audit Program (MDSAP) pilot has started, and the acceptance of the MDSAP reports in lieu of ANVISA audits by Brazilian regulators, Health Canada, Australia and the US FDA is exciting. Do you think MDSAP will dramatically reduce QSIT inspections?
Slide 10 of 13
Rob Packard, Presidentwww.MedicalDeviceAcademy.com
rob@13485cert.com
Question #8You perform a lot of mock-FDA inspections. What is the most valuable thing your clients have learned during your simulated QSIT inspections?
Slide 11 of 13
Rob Packard, Presidentwww.MedicalDeviceAcademy.com
rob@13485cert.com
Question # 9Many companies seem to use a memo to respond to FDA 483s, but what do you recommend to clients with regard to format and content of an FDA 483 response?
Slide 12 of 13
Rob Packard, Presidentwww.MedicalDeviceAcademy.com
rob@13485cert.com
Question #10You and I have both been helping foreign firms with responding to Warning Letters with automatic detention. For anyone that doesn’t know what an “automatic detention” is, could you please explain it? Also, could you please explain how the reaction to FDA 483s and warning letters should be different if the manufacturer is a foreign firm?
Slide 13 of 13
Rob Packard, Presidentwww.MedicalDeviceAcademy.com
rob@13485cert.com
Do You Need Training?http://bit.ly/Lead-Auditor-Course
Slide 14 of 13
Rob Packard, Presidentwww.MedicalDeviceAcademy.com
rob@13485cert.com
Need help with regulatory compliance?
Rob Packard
rob@13485cert.com
+1.802.281.4381
rob13485
Slide 15 of 13
Rob Packard, Presidentwww.MedicalDeviceAcademy.com
rob@13485cert.com
Glenn@MedicalDeviceAcademy.com
+1.561.308.3093
If you can’t reach me…
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