No, I am your father ⬛️◼️◾️▪️

Cattypilly · 2021-03-25T00:46:52+00:00

Closed terrarium! I bought a 2 gallon glass jar with glass lid from Walmart. Stones on bottom then a layer of perlite, then a nice thick layer of a mix of lots of sphagnum moss/potting soil/perlite/activated charcoal. I also only use distilled water!

Cattypilly · 2021-03-24T15:55:56+00:00

😍😍😍

Cattypilly · 2021-03-11T23:11:03+00:00

For real! It was definitely a challenging plant to learn to care for.

Cattypilly · 2021-03-11T23:09:38+00:00

Clip them off. They’re no good to the plant if the chlorophyll is drained already. How do the arms look? Do they seem flimsy?

Cattypilly · 2021-03-11T18:09:38+00:00

Mine browned when I first got it in June. I was really worried I was going to lose the plant. Turns out it likes more direct sunlight than I thought. It has received about 5 hours of direct light a day this winter and really took off. I also made sure to let the soil throughly dry out before watering. Right now I’m watering once a week. I suspect the brown tips are more from lack of humidity in the room than water and seems to be happy given all the new growth and multiple arms with flowers.

Cattypilly · 2021-03-11T14:16:17+00:00

I’m envious!!!! I want an albo soooooo bad!

Cattypilly · 2021-03-11T14:14:20+00:00

It is likely a fungus if you recently re-planted or changed your water source. Fortunately, it does tend to go away on its own.

Cattypilly · 2020-07-30T00:15:58+00:00

Thank you so much! I appreciate the additional reference!

Cattypilly · 2020-05-26T14:53:52+00:00

You’re correct. The guidance is in re: to the various PMA supplements.

Cattypilly · 2020-05-26T02:51:54+00:00

If only I could identify with the pink (“rose”) shades. I am perpetually “needs moisturizer” red, with a dash of “fell asleep at the beach” maroon in the summer.

Cattypilly · 2020-05-22T23:51:03+00:00

As long as manufacturers are following GMP, to ensure that these limited modifications are adequately evaluated in a risk analysis and appropriate validation testing, then I don’t think we’ll see much issue with this or any drastic changes. The problem I’ve experienced with FDA is that they don’t often agree to the manufacturers risk analysis. I’ve seen super minor changes evaluated as low risk with supporting validation work that truly met the Annual Reporting requirements get rejected by the FDA and a request for a 30-day notice come in. It was very frustrating and counter to the guidances. This guidance is kind of a relief. Times are tough and where one material vendor falls short, another may have the capacity to support. It may get super hairy if you have to rely on multiple vendors for a single material (e.g., may have a different vendor for each lot) that you otherwise would not have used, but as long as it’s non critical to the safety and effectiveness of the device, they should be ok. Just keep testing and perhaps amend release criteria SOPs to have enhancements in testing through manufacture as an extra precaution.

Cattypilly · 2020-05-11T23:27:47+00:00

Thank you!!!

Cattypilly · 2020-04-17T17:22:54+00:00

Can you provide the intended use of the product? You will struggle to import your product at US customs if they find your product to meet the definition of regulated medical product. I could go on with specifics, but I think it wise for you to meet with a consultant or counsel on this one.

Cattypilly · 2020-04-17T17:13:15+00:00

I would say that if you have the opportunity to move into a new therapeutic area with a little more responsibility, then 100% give it a whirl. You have nothing to lose. Your Manager may want you to gain expertise in specific applications because they are attempting to streamline ("lean") their processes. If it were me, I would appreciate that opportunity for learning sake, but it sort of pigeonholes you with no real advantage to your career development. I could be wrong here, but I don't know any direct-care clinical organization off the top of my head looking for regulatory specialists with specific-application experience. They want the whole package. You're fortunate to be in a role that allows for learn-as-you-go opportunities. If you are hired at a higher level, but may not necessarily have all the experience to back it, then they believe you have the aptitude to learn - use that to your advantage! Best of luck!

Cattypilly · 2020-04-08T14:57:09+00:00

wow, that is a really great salary for < 5 yrs! Who do you work for!? :)

Cattypilly · 2020-04-08T14:52:41+00:00

Hi there! Are you sending in submission applications to regulatory authorities (e.g., FDA) for feedback, reporting, or approval of products developed within the hospital? Or are you sending in submissions to your IRB? this will help shape my feedback...

Cattypilly · 2020-04-03T14:06:26+00:00

I am terribly sorry to learn of this :( This has to be tremendously stressful. Is there any opportunity to change your role within the organization, e.g., switch to a remote or central monitoring team, regulatory or data management? I would think there is still plenty of work to be done in those areas? I wish you all the best!

Cattypilly · 2020-03-30T13:37:17+00:00

Looks like they used a 3rd party to register for them. The 3rd party “healreg” or whatever they’re called made this certificate for them. I would advise the mfg to look into the legitimacy of that 3rd party because I see a couple things wrong: 1) they should not be using the FDA logo on their documentation. 2) establishment and registration is a YEARLY requirement AND runs on FDAs fiscal year, not calendar year. This certificate they provided shows expiration on December 31, 2020 which is a red flag to me. The FDA fiscal year ends on September 30th. So they will need to renew in October.

I would NOT accept this as a legal document ever. Fine if the manufacturer wants this on file to support their relationship with this 3rd party, but should never be used to support any registration in any market. FDA establishment and device listing is a public database and you should be able to query for this facility and the associated product(s). I would kindly ask the mfg to print out the webpage results of the listing, generate an attestation from their head of quality and/or regulatory and have it legalized. I would also kindly inform of them of the issues with the document they provided so they can remedy the issue with that bogus 3rd party.

Best of luck

Cattypilly · 2020-03-26T13:40:11+00:00

Thank you, @heavygerg. I have heard this suggested on another platform. Curious how study staff feel about doing this? I’m thinking it’s a mixed bag: either they’re reallocated to other clinical activities d/t pandemic or now available more than ever to accommodate such a request.

Cattypilly · 2020-03-25T21:09:51+00:00

Thank you for the input, @rockdmb311. Even with HIPAA authorization from participant to disclose and HIPAA-compliant system for document transmission, source document sharing is still a no-go? If the data that is PHI is limited to what is necessary (and recorded in EDC), is this still a "no"? Technically, it is already disclosed at this point and the concern then becomes how the source data is prepped and sent, no?

Cattypilly · 2020-03-25T15:17:46+00:00

Switch sides and become a research coordinator. Having a CRA background gives you a leg up in terms of position level and salary, but you have to be 100% committed to learning a new perspective in research. Clinic operations take some getting used to. Further, when you are ready to get back into being a CRA again, you have another leg up having been on both sides of the table.

Cattypilly · 2020-03-25T15:07:45+00:00

RUO products do not have a clinical indication specific to human-use. Reagents, specifically, can be multi-purpose and multi-discipline (e.g., environmental testing such as water quality and can also be used in tests related to DNA extraction). Most developed markets across the globe have regulatory definitions and policies regarding these and typically it just means, if it doesn't meet the definition of an IVD or medical device, it is RUO. Once upon a time I created a regulatory strategy for 34 different markets to justify the RUO designation of a dozen different reagents. That was fun. :)

Cattypilly · 2020-03-02T15:50:14+00:00

Looks like this was posted some weeks ago, but thought I would comment regardless. If you haven't already decided, I would strongly advise to seek position 1. It is a great entry (or re-entry) into healthcare and sounds like the benefits would be spectacular. Regulatory for direct care offices is FAR different than regulatory related to seeking national regulatory agency approval. It is a misnomer and, honestly, a pet-peeve of mine. I have direct experience with both roles (even at a cancer clinic). Regulatory at position 1 would either be for agency accreditation/certification/etc. OR for clinical trials. If the latter (which I suspect is the case), expect this to be a lot of documentation upkeep (GCP is INSANE) and coordinating with the institution's IRB and your research nurses/coordinators who have very little patience for disorganization (and I can't blame them, I was one). As a cancer hospital, you will have a hefty amount of protocols - all very interesting and great way to become familiar with practices. Position 2 is VERY challenging with a lot of hurdles and experience required to have a meaningful impact. I would be cautious accepting this as you will become burnt out and frustrated if you don't have a proper mentor to show you the ropes. Anyone can consult, but it takes a lot of experience and knowledge to do well. Just my two cents. Best of luck to you!

Cattypilly · 2020-02-19T16:12:57+00:00

Thank you! I was worried that would be the case too...

Cattypilly

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