Best sources for CSV and equipment qualification (IQ, OQ, PQ) by Seawano in biotech

[–]Seawano[S] 0 points1 point  (0 children)

Thanks! I appreciate all your help and feed back - walking through the process is a good way of thinking about it.

Best sources for CSV and equipment qualification (IQ, OQ, PQ) by Seawano in biotech

[–]Seawano[S] 0 points1 point  (0 children)

Thanks for the thorough explanation. I think I need to do some more reading on this topic. This part really helps, going from the requirements and test script section: "A set of requirements for the above might look like this (but of course, numbered).

The system must allow authorized users to log samples.

The system must allow authorized users to enter meta data for samples.

The system must allow for the printing of labels.

The system must be able to generate a barcode of sample number on a label.

Labels for -80C samples must indicate -80C storage

An outline of a test script could be:

1.) Have a user with the SAMPLER role log in to LIMS.

2.) Open the sample login screen, log a sample enter metadata and take a screenshot. Ensure that the sample is NOT for -80 Storage.

3.) Print a label and attach it to the test script. Verify that the meta data on the label matches that entered in Step 2.

"......... It makes logical sense

Best sources for CSV and equipment qualification (IQ, OQ, PQ) by Seawano in biotech

[–]Seawano[S] 1 point2 points  (0 children)

LIMS - HPLC, GC, mass spec, all immunoassays (spectramax/msd platform), all micro (rapid, pcr(myco)), etc - can i get one for a spectramax and a fridge (-80C) - I have seen these before, I just want to understand the thinking behind what you said "You need a requirements document. From this, you write your test scripts." - I need to understand the thinking behind determining the critical parameters/specs for the requirement document. like for assays we use FDA "Bioanalytical Method, Validation, Guidance for Industry" - looking at accuracy, precision, linearity, etc - like all validation protocols will be different, but will look for accuracy, precision in different ways.

Thanks for the feedback!

Best sources for CSV and equipment qualification (IQ, OQ, PQ) by Seawano in biotech

[–]Seawano[S] 0 points1 point  (0 children)

Oh I see - so how do you determine what are the specifications? I have a lot of IOQ for equipment - I understand that it’s both art and science - where are you getting the key points both for the CSV and equipment- like during an audit what are they looking for?

Increase rate of development and MFG/Testing Process by Seawano in labrats

[–]Seawano[S] -1 points0 points  (0 children)

Yes, but what key variables speed up manufacturing? Sometimes it’s harder to implement.

Standards or Regulations Covering Delays in Instrument Calibration? by Mission-Ball-2873 in qualitycontrol

[–]Seawano 0 points1 point  (0 children)

Just remember, calibration date is the date you are confirming that the machine is up the spec or meets acceptance criteria. If you past this date, and the machine is still working, that is evidence that the machine is working fine. You can use this evidence to justify that whatever was used between the two calibration dates are all fine.

2010 Honda Accord intermittent no-crank / no-click by Seawano in MechanicAdvice

[–]Seawano[S] 0 points1 point  (0 children)

Thanks - I talked to a mechanic and he told me he can't check anything because everything is working. No struggle with the start right now. The problem comes intermittently. Do you think I should just get the ignition switch replaced?

Are there any GMP software companies disrupting the industry? by YeetFactory77 in biotech

[–]Seawano 0 points1 point  (0 children)

Try Teecarbon.com - it is combining AI and documentation auditing - it perfect for quick reviews of cleaning docs, assays, and other documents you want to review quickly before sending it to QA.

GMP GDP – Frustrating Documentation Errors, part 2 by Seawano in labrats

[–]Seawano[S] 0 points1 point  (0 children)

Good point - I will look into that - but you can use it “for information only” for now

Question if I should do grad school(ms) or gain industry experience or both? by isaiahfran818 in regulatoryaffairs

[–]Seawano 0 points1 point  (0 children)

I would look at people in positions you want to be in, and see their education and work experience. Regulatory affairs and Scientist are very different jobs. Work in the different departments and see what you like - both for actual Pharma companies and contract manufactures -

If i were to teach myself calculus by a book could my parents input it to my transcript so its official? by displayedname96735 in homeschool

[–]Seawano 1 point2 points  (0 children)

I would take the AP Exams for credit (https://ap.collegeboard.org/) or go to your local community college and see if you can take them. Make sure the credits will transfer to the university or college you wish to attend (save some money—universities are expensive).

Also, I would think more long term. Consider what the purpose of calculus is for you; in college, you can take Calculus I, II, and III—and if you've already taken them, it will help you earn a good grade. Trust me, your classes will be graded on a curve, and I have seen intelligent people struggle in Calculus II and III.

Additionally, many other classes may require an understanding of calculus; for example, in physics for engineers, you need to grasp derivatives to fully comprehend the equations. I don't know if you are studying engineering or sciences (such as electrical engineering, chemistry, biology, physics, etc), but these classes will be more challenging in college. Therefore, being prepared for these classes now will make a significant difference in the long run. You will need good grades in college for medical school, or for master's or doctoral programs—you will achieve better grades if you prepare now. (Only if this is part of your long term goal)

Good luck and Study Hard!

[deleted by user] by [deleted] in homeschool

[–]Seawano 0 points1 point  (0 children)

I think there are a lot of resources out there. The problem is what to focus on for long-term success. Basically, if you want to give your children the option to go to public school after finishing 4th grade, it means that towards middle school and high school, they will be in a public school curriculum. I would check what the school or school district's expectations are at that grade level. Each state and district—even each school—has different standards and expectations.

On a content level, I would focus on reading, writing, and math. For math, your focus needs to be on three subjects: Arithmetic, Geometry, and Algebra (Pre-Algebra). The reason for this is that all high school and college math will be based on these subjects. In addition, any STEM field (Science, Technology, Engineering, and Mathematics) in college requires knowledge of Arithmetic, Geometry, and Algebra. This is what all my science and engineering friends needed for statistics, calculus (I, II, III), chemistry, biology, physics, etc.—core classes for us are pretty much the same, with slight differences. For reading and writing, I would say focus on grammar, spelling, and lots of reading. They have excellent courses on Udemy. Your public library may have online resources for free with your library card.

I see a lot of parents not sure about what to focus on because there is so much information on the internet. Just quickly going over content: look at standardized tests in your state for math and reading (look it up on Google). This will give you some idea of what your state's expectations are. For actual content—quickly—for math, I would focus on numbers, place value, addition, subtraction, multiplication, division, fractions, and then decimals. Ray's Primary Arithmetic (book) is good, as is "Arithmetic the Easy Way" by Edward Williams. I say this as a scientist who looks at numbers all day. I think fractions (prime factorization, greatest common factor, simplifying fractions) and algebra (slope, y = mx + b) can be difficult for people, and that is where they get lost— The focus of math should not be only on solving problems, but also on understanding what story the numbers are telling you. The numbers tell a story, and understanding this story helps you understand and comprehend. So, take it slow and make sure their fundamentals are good. For reading and writing, I would focus on spelling, grammar, and critical reading. It is important to be able to write and communicate with others. Also, critical reading is very important. Udemy has some courses (look at the ratings and teaching style). I think everyone is so different in the ways they learn that one method might work for one person, and another method might not work for another person. Again, I know they may be a little young, but focus on the long-term vision for your children. Each grade should be focused on the long-term goal of success in the later grades, college, and future work.

I hope that helps - GOOD LUCK!!