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Resources

Webinar – Deploying Risk-Based Thinking within Management Systems

Webinar – Impact of Pandemic on Regulatory Trends

Webinar – Champion of Change – 3Cs to Success

Webinar – GMP Compliance Issues for Legacy Products

Webinar – CMC Considerations for Cell and Gene Therapy Products

FDA Addresses Cell and Gene Therapy Manufacturing Challenges

Although cell and gene therapy (CGT) products that treat previously untreatable diseases are being approved, manufacturing these products can be challenging.Cell therapy manufacturing uses living cells, so stability can be an issue for both source materials and final products. Frequently the shelf life of these products is just a few hours.This presents logistical issues, including […]

Assessment – FDA Investigator Snapshot

Assessment – Site Snapshot

Report – State of Pharmaceutical Quality

Sample – 510(k)

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