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Investigator Feedback

  • 1.  Investigator Feedback

    Posted 25-Jan-2017 14:00
    Hi!  Has anyone been inspected by Francis Guidry?  Curious to find out about his audit style, hot topics, etc. 

    Thanks!

    ------------------------------
    Tina O'Brien RAC, MS
    Director of Regulatory Affairs
    Aroa Biosurgery
    Auckland
    New Zealand
    ------------------------------


  • 2.  RE: Investigator Feedback

    Posted 26-Jan-2017 09:59
    Hello,
    Any opinion on this.
    If using ascorbic acid as a pH adjuster in a formula in Dietary supplement at 0.45% of a 36 gram serving size would there be a position to not include the VItamin C as a claim?

    ------------------------------
    Susan Jackson
    SPRING LAKE NJ
    United States
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    Original Message


  • 3.  RE: Investigator Feedback

    Posted 26-Jan-2017 14:46
    I do no have inspection experience with this inspector.

    You could search "FDAZilla.com" for any 483 or inspection reports he authored.

    ------------------------------
    Gary Syring RAC
    Prin Consultant
    Quality & Regulatory Associates LLC
    Stoughton WI
    United States
    ------------------------------

    Original Message


  • 4.  RE: Investigator Feedback

    Posted 31-Jan-2017 19:04
    I've Googled this guy extensively and purchased his report from FDAzilla (which IMO was NOT worth $795), but am coming up short with respect to any meaningful intel on his recent device inspections or his style.  I can't even find a photo of him.  :(


    ------------------------------
    Tina O'Brien RAC, MS
    Director of Regulatory Affairs
    Aroa Biosurgery
    Auckland
    New Zealand
    ------------------------------

    Original Message


  • 5.  RE: Investigator Feedback

    Posted 31-Jan-2017 20:35
    I don't think much information is available regarding individual FDA inspectors.  I've never heard of anyone routinely doing this in advance of an inspection.  If it were useful to research them, I think this would have been incorporated into virtually every US company's SOP on preparing for an inspection by now.  I don't think it has been.

    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Durham, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------

    Original Message


  • 6.  RE: Investigator Feedback

    Posted 31-Jan-2017 21:03
    Oh well, it was worth a try :)

    ------------------------------
    Tina O'Brien RAC, MS
    Director of Regulatory Affairs
    Aroa Biosurgery
    Auckland
    New Zealand
    ------------------------------

    Original Message


  • 7.  RE: Investigator Feedback

    Posted 31-Jan-2017 23:28

    Yes, worth a try.  But maybe not $795. :)



    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Durham, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------

    Original Message


  • 8.  RE: Investigator Feedback

    Posted 01-Feb-2017 08:29
    All:
    Maybe I am missing something here. Investigators are trained and must follow the QSIT process. (Quality System Inspection Technique) plus Guide to Inspections of Quality systems. Within those guides there are specific sets of questions and investigational routes that are followed. Its an interesting and very long read if you have the time. By its design, the person doing to inspection is relatively generic, impartial, and neither lenient nor overly critical. Basically, it is what it is. 
    If the QMS system meets requirements, then rest easy. Recently, we had our inspection and we all thought we understood the inspectors "hot" topics and were prepared. To no avail, they went in a completely different direction. So, my suggestion, is tighten up the ship and learn from the experience. Nobody wants a 483, however, its a reality.

    ------------------------------
    Gregory Kleinert
    Biocoat, Inc.
    Warrington PA
    United States
    ------------------------------

    Original Message


  • 9.  RE: Investigator Feedback

    Posted 01-Feb-2017 08:48
    While you're right that inspectors follow QSIT, this is only a framework for inspection.
    Each inspector is different, has a different style, as well as expertise and experience. I can guarantee that you will not get the same questions from someone with background in nutrition or biology on your software or electro-mechanical device, and someone that has engineering background.

    Your audit prep and selection of SMEs will likely depend on the inspector.
    If you have an inspector that is very confrontational, you probably don't want to select SMEs that can't handle the pressure.
    You may spend more time reviewing certain documentation depending on the inspector's expertise and past inspections. Of course, fixing problems just before the audit may raise flags, so it's probably not a good idea; however, if you identify problems early, you can prepare for the response, either during the audit or after you receive your 483.

    I'm sure there are other many other considerations.

    Researching the inspector would always be one of the things done during the audit prep in my experience.

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    Michael Zagorski RAC
    Pittsburgh PA
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    Original Message


  • 10.  RE: Investigator Feedback

    Posted 02-Feb-2017 13:44
    Hi Michael,

    That is exactly what I'm seeking - the non-tangible stuff that's not available through Google or a database.  Real life experience with the person.

    Honestly, I research anyone from any regulatory authority/notified body that I'm working with so I can be cognizant of their background during the process.  I like to see what they look like, as well. 

    I've been through what seems like a bazillion audits/inspections during my career, so I know the drill.  My desire is to seek out information that will help myself and my team better communicate with these visitors from their arrival, rather than "learning" them during the 4 days we spend together.

    Tina

    ------------------------------
    Tina O'Brien RAC, MS
    Director of Regulatory Affairs
    Aroa Biosurgery
    Auckland
    New Zealand
    ------------------------------

    Original Message


  • 11.  RE: Investigator Feedback

    Posted 02-Feb-2017 14:20
    Tina,

    It would be good to have actionable attitude to be ready, willing and able to deal with any kind of inspectors under all possible situation.

    We should still be able to even accommodate "touchy-feely" people/auditors/inspectors. 

    HOW?

    Just provide what they ask and what they need!

    If s/he asks you to jump, just ask back "how high should I jump"?

    Thank you.

    s/ David
    ______________________________________________
    Dr. David Lim, Ph.D., RAC, ASQ-CQA 
    Phone (Toll-Free): 1-(800) 321-8567

    NOTICE: This communication (including any attachments) may contain privileged or confidential information intended for a specific individual and purpose, and is protected by law. If you are not the intended recipient, you should delete this communication and/or shred the materials and any attachments and are hereby notified that any disclosure, copying or distribution of this communication, or the taking of any action based on it, is strictly prohibited.



    Original Message


  • 12.  RE: Investigator Feedback

    Posted 02-Feb-2017 12:44
    In considering this question, I am not certain there is inspector feedback that would lead me to change my approach to inspection preparation and inspection readiness. 

    My strategy for inspection readiness and preparation is pretty straightforward and has proven very successful in terms of avoiding observations. 

    Keys to Inspection Success:
    1. Run the business in compliance with applicabe regulations
    2. Record and maintain the documentation needed to demonstrate compliance 
    3. Conduct regular internal audits using QSIT techniques 
    4. Have an SOP on Inspection Preparation and train everyone on the procedure; designate a front room and back room and support personnel
    5. Select your SMEs and give them specific training and coaching on interactions with the inspector; make sure everyone has a clear understanding of expectations for inspection room behavior
    6. Prepare documentation in advance where possible; company overview, org chart, CAPA logs, list of previous 2 years complaints, nonconformance log are all documents that will be requested; DHF's could be requested. Have these reviewed, scrubbed and printed before the inspector shows up.
    7. Treat the inspector with courtesy and respect at all times. State your case but avoid arguing with the inspector at all costs. 
    Many companies get in trouble because they like to handle their issues outside of the CAPA system and/or without creating nonconformance records. This is important documentation that provides evidence of compliance. Having substantive and well documented CAPA will give inspectors confidence that you are doing the right thing. Have a competent reviewer pre-review every document the inspector requests and flag/correct any issues before the record goes into the inspection room. How quickly and efficiently you can present requested materials is key indicator of a company's level of control. Being able to turn around requests quickly will also build confidence with the inspector. 

    Lastly, don't be afraid of a getting a 483. Yes, I would prefer to avoid them where possible but getting one is not the end of the world. They can be managed. 

    ------------------------------
    Scott King
    Vice President, Regulatory Affairs, Quality Assurance & Chief Compliance Officer
    Ceterix Orthopaedics
    Fremont CA
    United States
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    Original Message


  • 13.  RE: Investigator Feedback

    Posted 03-Feb-2017 09:20
    I agree to a point. Any good inspection prep includes all the items listed, but I have been able to use knowledge of the inspectors effectively as well. For instance, "national experts" in anything tend to expect far more technical details in their areas, but also be very conversant with detailed technical jargon in things like software validation. It is useful to know that up front rather than having to adapt to it in the course of the inspection. Not imperative, but helpful. Some inspectors like to spend a lot of time in CAPA and use it to go other places. Others, while adhering to QSIT, spend a minimal amount of time there and move on to design and process controls, because that is the area they have more expertise in.

    That said, keys to an inspection are a sound system, knowing where your weaknesses are, preparation and training of the entire team, and being a good judge of "people" dynamics and adapting to those as you go. Background on the inspector is only one very small part that "might" help with the dynamics part - the preparation and system strength pieces are much more important.

    g-

    ------------------------------
    Ginger Glaser RAC
    Vice-President, Quality and Regulatory Affairs
    Maplewood MN
    United States
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    Original Message


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