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3 Takeaways from the FDA 483 to J&J Covid-19 Vaccine Maker

FDA has issued a Form 483 to the J&J Vaccine manufacturing site of Emergent. Here are the key takeaways.

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How To Calculate Cleaning Agent Residue Limits

Currently, there are two approaches to evaluate Cleaning Agents toxicology. Lets evaluate both in this blog.

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Cleaning Validation Guidelines - A Complete List 2021

All major regulators have revised the Cleaning Validation Guidelines in the last 2 years. Here is a complete list.

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Digitising Cleaning Procedures: A $50 Billion opportunity

Pharma Companies have a great opportunity to recover lost productivity, as much as $50 Billion every year

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A Brief History Of 21 CFR Part 11: Electronic Records And Electronic Signatures

FDA gave electronic signatures legal equivalence with traditional “wet ink” signatures on paper in 1997.

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How technology can help solve top 3 FDA compliance challenges

Non-compliance is the biggest threat to the growth story of the Indian Pharmaceutical Industry today

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Top 5 trends in non-compliance in Pharma Manufacturing

Pharmaceutical companies operate in one of the most dynamic environments.

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Cleaning Validation in the Pharmaceutical Industry

Cleaning validation has been the most debated compliance topic of the year 2018

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