Areas Tim Sandle is Knowledgeable in:
- Microbiology
- Pharmaceutical processing and manufacturing
- Bacterial toxins (including endotoxin)
- Laboratory management
- Cleanrooms
- Contamination control
- Cleaning and disinfection
- Pharmaceutical technology
- Laboratory consumables and suplies
- Life science vendors
- Risk identification, risk ranking and risk analysis
Techniques Tim Sandle Uses:
- I am familiar with quality risk management (ICH Q9).
- I am famiilar with structured problem solving tools sich as Hazard Analysis Critical Control Points (HACCP), Failure Modes and Effects Analysis (FMEA), Fault Tree Analysis (FTA)
- I am familiar with heuristic problem solving methods
- I am familiar with Total Qulaity Management (such as the Plan-Do-Check-Act approach)
Tim Sandle's Problem Solving Skills:
- Computing and internet
- Biostatistics
- Pharmaceutical microbiology
- Technical writing
- Laboratory management
Tim Sandle's Problem Solving Experience:
- - I have project managed several redesign laboratory and cleanroom start up operations
- - I have audited sveral laboratories in orde to streamline their processes (along the lines of 'how to test more effectively for less cost')
- - I have validated (from DQ, IQ, OQ and PQ) sveral large items of processing and laboratory equipment, such as a barrier isolator system
- - I have undertaken method development for novel drugs, including devising test assays (such as bacterial endotoxin)
- - I have developed several environmental monitoring programs for facilities
- - I have implmented a cleaning and disinfection programme (automated and manual) for a pharmaceutical factory
- - I have authored several books on pharmaceutical microbiology, sterility assurance and contamination control