Business Intelligence Solutions announced today it will begin a new summer webinar series, Early Phase GMP, starting on July 25, 2012, for Life Sciences companies who need to address the FDA regulatory requirements for Good Manufacturing Practices.   

The webinar will address the FDA regulatory requirements and a strategy for Good Manufacturing Practice for drug produced for clinical trials. 

Focusing on early phase clinical supply manufacture, the specific topics to be discussed include:

• what the FDA Guidance for Phase 1 GMP recommends,

• why the FDA pre-approval inspection requirements are important for Early Phase  manufacture,

• how a proven strategy balances FDA's requirements and non-binding recommendations

As a new product enters early phase clinical trials, the product and process are not yet well-understood.   As a result, the manufacture and testing of the product present a potential source of additional variability in the evaluating clinical trial data. 

Early Phase GMP Quality Systems ensure accurate records that support (1) CMC Regulatory in filing and discussing clinical lots, and (2) future Pre-Approval Inspection:

 §     Evidence of manufacturing recorded reliably, including test reports

 §     Linkage of pilot-scale processes and specifications back to development reports

 §     Evidence of facility controls against cross-contamination

 §     Quality Assurance to discern invalid or altered records

 §     Archives, documents, methods and specifications controlled for how and when and by

     whom changes were made, and to ensure these were authorized

 §     Lot release solidly and carefully justified in full consideration of patient need.

About the Speaker: 

Dr. Margery Ross has 20 years of industry experiencein biopharmaceuticals, particularly as head of Development  Quality Assurance at Medarex, the New Jersey biotechnology company which was acquired in 2009 by Bristol Myers Squibb.

From 2003 - 2010 at Medarex,  Dr. Ross  directed  20 – 25 in  record review, investigations, lot release,stability, and documentation.  Dr. Ross approved all deviations and CAPAs with heads of Compliance and CMC Regulatory.   Periodically, Dr. Ross also lead Compliance and Raw Materials Approval and Qualification.