Who we are?

Vincent S. Venturella directs the activities . He has

• 12 years experience as a cGMP Trainer/Auditor
• extensive experience in cGMP/QA/ Regulatory Issues including BPCs
• experience in compiling relevant data for CMC submissions
• 28 years experience in the analysis of pharmaceuticals and intermediates
• wide experience in  technology transfer and in Pre-Approval Inspections.

Qualifications

• Followed the progression of the current Good Manufacturing Practices regulations from inception (February 28, 1979) to the present.
   
• Primary cGMP trainer/compliance officer/auditor for the Hoffmann-La Roche Kilo Lab and Pilot Plant 1978 - 1985.
   
• Organizer and chief trainer for EAS cGMP and validation short course from 1987.
   
• Responsible for analytical issues, CMCs, practical assurance and compliance (to 1990), Ohmeda PPD (Anaquest, Inc.) 1985-1995.
   
• Successfully participated in domestic and international technology transfers, PAIs, validations and protocol development.