5 Commonly Overlooked Laboratory Checks for your FDA cGMP Audits

This blog post is a guest post from Edword Simpson, technical engineer at Science Exchange lab, RS Calibration. Ensuring that everything in your laboratory is ready for any upcoming audit is a nail-biting task. The annual FDA audit for compliance with regulatory guidelines, like the current goods manufacturing process (cGMP) is especially tedious. Manufacturing processes and […]

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Small Biotech Stories: American CryoStem

Some companies skirt regulations, opting instead to go off the radar. American CryoStem‘s Anthony Dudzinski‘s first words to me on the phone during our discussion were, “We follow the rules.” They’ve accumulated the greatest depth of adipose tissue-based cellular technology research relative to creating their laboratory and processes at a clinical cGMP level, and they’ve […]

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