AREAS OF CURRENT CONSULTANCY WORK AND EXPERTISE

Current Consultancy Work

Microbiological RIsk Assessment related to the introduction of a new

biological diagnostic device, on to an existing pharmaceutical

manufacturing site

Delivery of environmental monitoring, contamination control and media fill modules, on an Aseptic Manufacturing course

Developing the profile of the microbiology laboratory for a leading generic pharmaceutical manufacturer, by the creation of environmental monitoring summaries, training modules and laboratory metrics

Areas of Expertise

Sterile Operations

Facility Design

Facility Qualification

Facility Operation

Facility Management Systems

Facility trouble shooting

Regulatory Inspection preparation

Regulatory Inspection recovery

Quality Systems

Deviation and CAPA management systems

Change Control

Validation and Qualification

Audit (internal and external)

Quality Control

Microbiology

Environmental monitoring and data management

Sterile and non sterile product testing

Media fills

Water testing

Sanitisation

Contamination trouble shooting