TRANSDERMAL DRUG DELIVERY ARTICLES

frankly-fran-better Embrace Packaging and Delivery Systems Designed for Today's Standards

Regulations and standards for drug delivery systems and packaging are ever evolving and expanding, making it harder and more costly for older products to meet them. In this article, Fran DeGrazio explains why it is imperative that pharma companies consider new product adoption. 

TRANSDERMAL DRUG DELIVERY VIDEOS

Is CAPA still part of the requirements picture for the new QMSR? In this segment of the Drug Deliver Leader Live! event New FDA QMSR: Its Role in Part 4 Compliance for Combination Products, consultant Ed Bills of Edwin Bills Consultant discusses changes in the treatment of corrective and preventive actions.

In this segment of the Drug Deliver Leader Live! event New FDA QMSR: Its Role in Part 4 Compliance for Combination Products, DDL Executive Editor Fran DeGrazio enlists consultants Laurie Auerbach of Compliance Prodigies and Ed Bills of Edwin Bills Consultant to summarize where Part 4 is documented in the new guidance.

In this segment of the Drug Deliver Leader Live! event New FDA QMSR: Its Role in Part 4 Compliance for Combination Products, DDL Executive Editor Fran DeGrazio asks consultants Laurie Auerbach of Compliance Prodigies and Ed Bills of Edwin Bills Consultant to identify which organization in a combination product manufacturing process are responsible for design controls – the sponsor company, the contracted component provider, or both.

What does the addition of ISO 13485 as reference in the new QMSR mean for those working to comply with 21 CFR 820? In this segment of the Drug Deliver Leader Live! event New FDA QMSR: Its Role in Part 4 Compliance for Combination Products, consultant Laurie Auerbach of Compliance Prodigies explains the relationship between the two guidance documents.

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