LVASQ

MAY MONTHLY MEETING

"Detecting Fraud in Mfg."

Speaker: Mel Charles - Retired Consultant, Assoc. Director, Sr. Scientist

Date: Thursday, May 20, 2010

Abstract: Mel will present examples and outline strategies which will enable an auditor to detect suspect activity.

Speaker Bio: Mel Charles, now retired, was a Process and Compliance consultant to Fortune 500 and Biotech Companies; a former Associate Director of International Process Development for Fort Dodge Animal Health, a Division of Wyeth; and a former Sr. Scientist at Ecogen, an Ag-Bitoech Company, now dissolved. In those capacities: she developed a cGMP system for an equipment manufacturer; conducted cGMP audits; reviewed CMCs, Stability and Validation Protocols, and SOPs; was responsible for certain clinical trial supplies, as well as the scale up and transfer of fermentation, recovery, purification, formulation, and packaging of biotechnology derived products. She has conducted patent assessments, due diligence assessments, technology assessments, and contractor evaluations for biotech research. She excels at process trouble-shooting: Example – Crystals of active ingredient were found in stability samples of a gel soon to be manufactured for market. In less than 3 months, she designed experiments and modified the process to eliminate crystal formation. No changes to NDA or approvals by FDA were required to implement the changes. The Product was successfully launched on time. Example – Water was migrating from the Ecogen formulation (developed by others). Water condensed on the bag surface leaving packages wet and rendering the active ingredient inactive. She used a commercially available stabilizer, revised the formulation, redesigned the bag, and demonstrated improved stability on pilot scale in time for the next production season. New production had no water migration. Example – Resolved regulatory/process question for producer of novel vaccine.

Mel received her B.S. in Biology from Moravian College. She earned her M.S. and Ph.D. in Chemical Engineering at Lehigh University.

Location: Stefano's Restaurant --2970 Linden Street ---- Bethlehem, PA.

Take Route 22 to Route 191 exit. Go south on 191 which turns into Linden Street in Bethlehem City. Stefano's will be on your left approx. 1.6 miles.

FUTURE MEETINGS

The May Meeting is our last meeting until the Joint Meeting with Reading in September.