GLP Quality Consulting, LLC

News:

2/19/2010-Data Falsification Reporting/Proposed Rule (FDA) (PDF) 

GLP Quality Consulting to attend the 26th Annual Society of Quality Assurance (SQA) meeting April 27-29, 2010 in Cincinnati, OH.  Please visit our display at the Consultants Table.  

8/27/2009-Health Canada Draft Guidance Document: Non-Clinical Laboratory Study Data Supporting Clinical Trial Applications, New Drug Submissions, and Drug Identification Number Applications Issued (HTML)

8/17/2009-New FDA GLP Warning Letter Issued (HTML)

8/16/2009-New FDA GLP Warning Letter Issued (HTML) 

5/21/2009-New FDA GLP Warning Letter Issued (HTML) 

5/16/2009-Outsourcing Survey.  Contract Pharma issued a new survey on current outsourcing trends. (PDF) for more see their website at www.contractpharma.com 

4/21/2009-Crystal City Workshop -Incurred sample analysis follow-up paper from AAPS (PDF)

2/17/2009-New FDA GLP Warning Letter Issued (HTML)

2/18/2009-Project on Government Oversight Report on Medical Device GLP Status "The FDA's Deadly Gamble with the Safety of Medical Devices" (HTML) 

12/16/2008-FDA Guidance for Industry "Genotoxic and Carcinogenic Impurities in Drug Substances and Products:  Recommended Approaches" (PDF)

9/4/2008-ICH Draft Guidance "M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals" (PDF)

GLP Quality Consulting to attend the 24th Annual Society of Quality Assurance (SQA) Meeting April 22-24, 2008 in Memphis, TN.  Please visit our display at the Consultants Table.

4/15/2008-New EPA GLP Advisory No. 82 (PFF)

3/24/2008- ICH Draft Guidance "(S2R1) Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use (PDF)

January 2008-EPA GLP Regulatory Update Presentation (PDF)

Hot Topic Papers:

GLP Hot Topic-Changes to FDA Form 483 and Warning Letter Procedures (Word Document) 

GLP Hot Topic-CRO and Vendor Audits during Economic Recession (Word Document) 

GLP Hot Topic-FDA GLP Modernization Status (Word Document) 

GLP Hot Topic- Bioanalytical Incurred Sample Re-Analysis (Word Document)

GLP Hot Topic-Test article Presence in Bioanalytical Control Samples  (Word Document)

GLP Hot Topic-Contributing Scientist Reports (Word Document)