About Stephanie Byrne

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So far Stephanie Byrne has created 5 blog entries.

Are You Ready for Serialization Implementation?

By |2022-01-11T09:56:18-05:0001/11/2022|

Are You Ready for Serialization Implementation? A 7-Point Checklist for Emerging Pharma Companies Serialization implementation is probably on your radar already if you’re an executive at an emerging Biopharma company. Manufacturers need to implement a serialization management solution to fulfill today’s requirements under the Drug Supply Chain Security Act (DSCSA). So [...]

Pushing “Fast Forward” on Serialization Requirements: What Manufacturers Need to Do for 2022

By |2021-12-07T12:19:34-05:0011/16/2021|

Pushing “Fast Forward” on Serialization Requirements: What Manufacturers Need to Do for 2022 Originally published as a MassBio Guest Blog Stephanie L Byrne is a senior supply chain consultant and serialization lead focusing on DSCSA project leadership. She has helped more than a dozen life sciences companies realize the greatest impact from [...]

2022 Industry Serialization Requirements: Assessing 3PL Options for Sending EPCIS Data to Distributors

By |2021-11-16T08:50:29-05:0011/16/2021|

2022 Industry Serialization Requirements: Assessing 3PL Options for Sending EPCIS Data to Distributors Pharmaceutical manufacturers currently share transaction data with their trading partners at the lot level. The Drug Supply Chain Security Act (DSCSA) mandates package level traceability by November 2023. Cardinal Health and McKesson are requiring that manufacturers provide fully aggregated [...]

Manufacturers Need to Start Now to Prepare for 2022 Serialization Requirements

By |2021-11-08T17:08:01-05:0011/08/2021|

Manufacturers Need to Start Now to Prepare for 2022 Serialization Requirements While the Drug Supply Chain Security Act (DSCSA) does not require manufacturers to send package-level serialization data downstream until November 27, 2023, the Big 3 distributors are accelerating this timeline and requiring that data by November 2022. Cardinal Health and McKesson [...]

DSCSA Saleable Return Requirements: What the Changes Mean

By |2020-11-20T09:34:26-05:0011/19/2020|

On October 22, the FDA issued a new guidance document: Wholesale Distributor Verification Requirement for Saleable Returned Drug Product and Dispenser Verification Requirements When Investigating a Suspect or Illegitimate Product – Compliance Policies The guidance includes a 3-year delay in enforcing the DSCSA's saleable returns verification requirement for distributors. The enforcement start date is [...]

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