Unlock your company's potential with my consulting services
EXPERT Microbiology INSIGHTS
Unlock your company's potential with my consulting services
Unlock your company's potential with my consulting services
Unlock your company's potential with my consulting services
Paul Talbot MSc. is an internationally known expert in medical device microbiology and tissue valve sterilization methods. With more than 20 years experience in the field, he is retained as a microbiology consulting resource by the industry's most successful medical device and biotech companies.
I partner with my clients to deliver robust solutions to ensure the safe production of sterile medical devices. I have decades of hands-on, practical experience in medical device, biotech microbiology, sterile and nonsterile manufacturing, product, process and water system contamination control, QA, QC, GMP, ISO standards, regulatory affairs, and global pharmacopoeia compliance.
Paul Talbot Microbiologist has over 30 years of experience in the microbiology and sterilization industry.
Specializes in medical device sterilization and liquid chemical tissue sterilization and associated global regulations, standards and testing.
Works closely with clients to understand their goals and challenges, and develop solutions that address their specific needs. His approach is collaborative, transparent, and results-driven.
Expertise and wide ranging experience of medical device sterilization processes including aseptic processing, cleanroom controls, and associated laboratory testing (sterility, endotoxin, bioburden), steam, radiation, ethylene oxide, and liquid chemical sterilants.
Expert knowledge of liquid chemical sterilization of implantable tissue devices, ensuring liquid chemical sterilization validations are conducted in accordance with the applicable ISO standards (ISO 14160, ISO 13408 series).
Extensive experience of cleanroom control, medical device microbiology, and applicable testing. Expert in product testing (sterility, endotoxin, bioburden), environmental monitoring, and other microbiological analyses in accordance with the applicable ISO standards and pharmacopeial requirements (ISO 11737-1 and -2, AAMI ST72, USP <71>).
Ensuring viral inactivation studies for tissue containing devices meet ISO 22442-3.
Ensuring sterilization validations are conducted in accordance with the applicable ISO standards for moist heat, radiation, and ethylene oxide processes (ISO 17665 series, ISO 11137 series, ISO 11135).
Management of multiple microbiology laboratories, related projects and global activities needed to meet quality requirements. Provides global expert microbiology support to the manufacturing operations, design of sterilization validations, completion of experiments, interpretation of data and preparation of reports, and communicating with regulatory authorises on microbiological issues.
Master of Science - Biomedical Sciences
Fellow of the Institute of Biomedical Sciences
Bachelor of Science - Microbiology Honours
Associate of the Royal College of Science
Director and Management roles
Over 30 years of experience
24 years in industry
7 years in clinical/research laboratories
QA/manager/engineer positions
Management & Leadership
ISO 13485 QMS (SAI Global)
Internal Auditing (Ashbrooke QA)
Quality Systems (AAMI)
Industrial Sterilization (AAMI)
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