QUALIFICATIONS
Michael Douthit
Michael has over 25 years of experience in the regulated pharmaceutical and medical device industries. In addition to extensive knowledge of ISO 13485 and ISO 9001, Jennifer has considerable experience with the implementation and continued compliance of numerous AAMI and International Regulations and Standards including:
- AAMI/ISO 11135
- AAMI/ISO 11137
- AAMI/ISO 11737
- AAMI/ISO 17665
- ISO 14644
- Medical Device Directive 93/42/EEC
- REGULATION (EU) 2017/745
Michael gained valuable insights into the manufacturing and sterilization of medical devices as a technical specialist with BSI. While working for this Notified Body, Michael was able to audit and analyze best practices in the medical device industry.
EDUCATION
BACHELORS DEGREE – BIOLOGICAL SCIENCES
Colorado State University
MINOR – Microbiology
Colorado State University
EDUCATION
- Implementing and Auditing an ISO 9000:2000 Quality System, ASQ
- Internal Auditing Training for ISO 13485, Stat-A-Matrix
- Risk Management for Medical Device Businesses, Processes and Products, ASQ.
- Exam Writing Workshop, ASQ
- Irving Pflug’s Microbiology and Engineering of Sterilization Processes
- Training on the Canadian Medical Devices Conformity Assessment
- System (CMDCAS) Accademia Qualitas, Inc.
- CE Marking of Medical Devices BSI
AFFILIATIONS
- AAMI Working Groups for EO, Radiation, Microbiology
PROFESSIONAL PROFILE
MEDICAL DEVICE
TECHNICAL EXPERT – MICROBIOLOGIST | BSI AMERICAS
- Plan, execute and prepare reports for microbiology and sterilization audits as part of Notified Body certification to various Standards and Regulatory Requirements.
- Participate in Certification assessments to ISO 13485:2003, EN ISO 13485:2012, ISO 13485:2016, ISO 9001:2005, ISO 9001:2015.
- Review Technical Documentation submission for compliance to MDD and/or MDR regulations.
LEAD MICROBIOLOGIST | BD MEDICAL
- Maintained the validated state of sterilization processes, ensuring timely release of product after sterilization.
- Supervised 7 direct reports in the release testing of finished goods and raw materials for medical device and pharmaceutical products.
- Developed and validated four Ethylene Oxide sterilization cycles per ANSI/AAMI/ISO standards into 6 newly commissioned chambers, ensuring the sterility and safety of product.
- Coordinate the validation and dose quality audits of new and existing product lines for sterilization via gamma and eBeam irradiation.
- Coordinate the sterilization process of products of 2 different manufacturing facilities (Sandy, UT and Nogales, Mexico)
- Ensured validation of new or changed products into appropriate sterilization modes.
- Supported and advised R&D on product, material and package changes, ensuring any changes would be compliant to sterilization standards.
- Performed technical audits of EO and irradiation sterilization facilities, to ensure compliance with procedures and standards.
- Performed internal audits of plant facilities verifying compliance to ISO13485, 21 CFR 210, 211 and 21 CFR 820.
SENIOR QUALITY CONTROL MICROBIOLOGIST | CORIXA CORPORATION
- Provided technical support and leadership maintaining GMP standards in environmental monitoring, water testing, stability testing, and release testing for finished products from aseptic manufacturing.
- Monitored hundreds of aseptic filling operations of more than 10 product lines, ensuring compliance per SOPs and FDA/GMP standards.
- Performed LAL, TOC, pH, and bioburden testing of the facility water system, ensuring water met FDA standards for RO water and WFI.
- Precisely conducted hundreds of aseptic tests per USP on final products, stability samples and raw material samples, verifying sample sterility and resulting in zero failed tests due to technician error.
- Wrote and revised QC SOPs to implement and update procedures, meeting GMP standards.
- Maintained environmental monitoring data on the computer, identifying production facility conditions.
- Trained personnel on SOPs in environmental monitoring and water testing, ensuring production operations were monitored by qualified QC personnel.
ASSOCIATE STUDY DIRECTOR | BIOSCIENCE LABORATORIES
- Streamlined testing procedures in a GLP facility, increasing efficiency of multiple product evaluations and reducing turn around time.
- Implemented system for maintaining stock cultures of more than 100 clinical and ATCC isolates, reducing test completion time by 90+%.
- Supported clinical studies, verifying informed consent forms, performing assays and documenting adverse events.
- Support D-studies, ensuring biological indicator performance.