Services       QA Experts

Andrew Torchia, Principal

Ph:(215)817-7424

email QA Experts


Services Provided

Validation review

Expert QA review of validation protocols, final reports and master plans.  Experienced in the following:

Equipment & Processes
Aseptic Processing
Filling & Packaging
Buffer & Media Vessels
Cell Culture & Purification
Liquid Fills
Lyophilization
Bioreactors
Purification Equipment
Autoclaves
Depyrogenation Ovens
Vial Washers
Glasswashers
Steam-in-Place (SIP)
Clean-in-Place (CIP)
Critical Utilities
WFI & Purified Water System
HVAC Systems
Clean Steam
Nitrogen
Compressed Air
Temperature Control Units
Incubators
Refrigerators/Freezers
Cold Rooms
Warm Rooms
Warehouses

Statistical Data and Trend Analysis
Apply the concepts of "Statistical Thinking" to your data and everyday work environment.

Address some of the issues, and avoid the problems and pitfalls, concerning the collection and use of data.

Understanding the fundamentals of variation.

Use visual data analysis for discovery and understanding. 

Table  and Graph Design for Effective Communication

Effectively communicate quantitative business data using tables and graphs.

Show how to select the appropriate medium of communication (table vs. graph, and which type) and how to visually design each component to express your message clearly and compellingly.

Show how to make the best use of the charting and graphing functions in Microsoft Excel.

Development of quality system metrics

Can assist in the development of quality system metrics and measures to monitor the effectiveness of the quality system and, when appropriate, to implement corrective and preventive action.  Effective use will drive the organization to higher levels of performance.

Problem solving, root cause analysis, continuous improvement

CAPA and deviation investigations

Product Complaints Handling

Investigation Management

Batch record review

Change control

Supplier quality management