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Conference Directory
Quality Practices for R&D CMC Laboratories
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Venue Name: Online Event
Country: United States of America
City: Palo Alto
State: CA
Number of Attendees: Unknown
Webinar or Virtual Event: No
Keywords: Laboratory Directors and Personnel,QA Managers and Auditors,Regulatory Affairs CMC Specialists,Contract Industry and Academic Testing Facilties,Internal R&D Laboratories,Project Managers with CMC Oversight.
Start Date of Conference:: 02-18-2010
End Date of Conference: 02-18-2010
Description of Conference: Why Should You Attend:
During product development, many experimental CMC studies to support process development and product characterization are conducted in non-GMP laboratories, including academic and contract facilities. However, the data generated in these studies may be utilized in product regulatory filings, making them subject to concerns about traceability and reproducibility. While there are no formal compliance requirements for R&D laboratories, emerging regulatory concepts in quality systems and quality by design place greater compliance pressure on R&D labs for sound scientific practices. Additionally, early-phase quality control testing may be performed in laboratories that are not fully GMP compliant, and are in fact much closer to R&D than GMP.
* A large number of CMC studies to support product development are not required to be performed in GMP laboratories.
* Data from supportive CMC studies are typically presented in regulatory dossiers which makes them subject to later review and verification.
* Lack of adequately documented early development data often becomes a cost factor for in-licensed products.
* Quality practices at academic and contract testing laboratories can greatly impact the utility of their CMC data.
* Some analytical laboratories erroneously interpret GLP as 'GMP-light'.
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Quality Practices for R&D CMC Laboratories
