How to Document Samples for FDA Detained Product
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Transcript of How to Document Samples for FDA Detained Product
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Picture PerfectBest Practices for documenting
sub samples for testing
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In this Tutorial…
• What to photograph• Recommended equipment for
photographing sub samples, etc.• Getting the best photos• Assembling and labeling your photos• Delivery to your FDA detention
resolution experts
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What to photograph
1. Photograph the entire lot.
Photo must include the entire palette, with the entry number, lot number, or container number visible and legible in the shot. (These have been marked out for confidentiality.)
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What to photograph
2. Sample bag (or box) itself
Be sure to include the front label and back label. Again, these have been pixelated for privacy. Yours must be clear and legible.
Front Back
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What to photograph
3. Picture of the product
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What to photograph
4. Picture of all sub samples
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What to photograph (Multi-export)
• Bar code• Lot Number• Entry Number• How many Subs• Date• Number of Subs
out of total
This must be repeated for each line of product being tested.
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Recommended Photo Equipment
• Point-and-shoot style digital camera or mobile device with flash (recommended resolution of 4.0 megapixels or higher)
• Basic photo viewer/editor (comes installed on most computers)
• Microsoft PowerPoint, Word, or equivalent software
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Getting the best pictures
1. Always consult your manual for proper operation of your camera.
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Getting the best pictures
2. Make sure the area you are taking pictures is well lit. Turn on additional lights or move the sub samples if necessary.(Dark locations make it difficult forthe camera to focus, even with the flash, and can result in blurry, unusable images.)
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Getting the best pictures
3a. Gently “half push” the shutter release to allow the camera to focus before fully depressing the shutter release to capture the image.
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Getting the best pictures
3b. If using a mobile device, tap the screen directly over the area you want in focus. The phone should adjust focus and brightness automatically.
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Getting the best pictures
4. Take the picture!
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Getting the best pictures
5a. Review each photo before moving on to the next image.
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Getting the best pictures
5b. Use the zoom controls and toggle switches to zoom in on important information like (Lot #, etc.) If you can’t clearly read it, we can’t read it either. Please retake the photo.
(Features may be different on your camera. Consult your owner’s manual.)
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Getting the best pictures
5c. If there is too much glare on the information in the picture, we can’t read it. Try turning your camera’s flash off, or turning on more lights so the subject is more evenly lit.
(Features may be different on your camera. Consult your owner’s manual.)
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Getting the best pictures
5d. If the information on your image is pixelated, we will not be able to read it. This delays the process and makes everyone grumpy. Please make sure your images are set to a high resolution and that text like the entry # and lot # are clearly legible.
(Consult your owner’s manual.)
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Getting the best pictures
6. Import the images into your computer.
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Getting the best pictures
7. Review your images using your computer’s photo viewer program. Many of these viewers allow for adjustment of brightness and contrast. If necessary, use these to improve the visibility of text in the image for optimum legibility.
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Emailing the Images
• Images MUST be clearly labeled in a Word, PDF, PowerPoint or equivalent file format. Each page must include– Entry Number– Line & Lot/Container Number– Date Sampled
EXAMPLE HEADERSAMPLE COMPANY INC., ENTRY #123-09877543-2, 001/001,
12/14/2015
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Emailing the Images
• Email completed packet to [email protected].
• Be sure to notify your favorite ABC Research Laboratories FDA detention resolution expert so they can assist you as soon as possible.
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Questions?
If you would like to know more about documenting FDA detained product, or have other FDA detention resolution questions, please let us know!