Thomas Dunkle Email & Phone Number

Responsible for ICH Q7 Quality System for PEG reagents and pegylated API QA representative to several partner programs and product development projectsResponsible for facility support including process validation and cleaning validationBatch Record review and product release systemManager QC/StabilityResponsible for ICH Q1A compliant stability program.

Contractor/ConsultantQuality Systems design and improvement projects Product Development Support and design controlMedical Devices and Pharmaceutical

For the first 2 years I was production manager for liquid and solid dosage forms of several pharmaceutical products.For the 3rd year I was the QC manager responsible for raw material, finished product and stability testing.Filed a 510 (k) for head lice product and worked on CMC sections for ANDAs and an NDA

set up initial QSR compliant system and got FDA/ISO approvalPrepared FDA 510 (k) submission for a spinal arthroscope and drug delivery device Lead project to obtain ISO 9001 certification and CE markImplemented FDA 21 CFR 820, QSR including design control requirements

Hired as a consultant to design and implement ISO 9001 and FDA 21 CFR 820 QSR Ciba Vision, implement a design control system to comply with the QSR requirementsBasic quality system design for several Ciba Vision suppliers

Worked with CMOs/suppliers to develop and implement quality requirements for productsDeveloped the project plans and facilitated the teams to support product development.Set up the complaint system and product specification master files.Coordinated the biocompatibility work required for FDA submissions and compliance with 21 CFR 58 and ISO 10993.

Various management assignments see below

Managed 17 scientists and technicians for process support, raw material testing and contract supplier managementLead a project that reduced polymer test cycle time from 9 days to 24 hours.Implemented the quality manual and procedures that passed ISO 9001 certification audit Facilitated TQM teams Designed a contract supplier validation program to facilitate.

Managed raw material testingDesigned and implemented the contract supplier management procedures Served on the steering committee that established TQMImplemented the Device Master Records for six contract product lines.Established a cross-functional Supplier Management Board Designed the system to rate the performance of 30 major raw material suppliers

Managed a group of 60 scientists and technicians including analytical chemistry, microbiology, statistics, toxicology and finished product quality assurance inspectorsPrepared supporting information for several Pre-Market Approval ApplicationsSuccessfully integrated technology from an acquired company into CIBA operationsDeveloped testing procedures that.

Managed 12 people responsible for product inspection, product release and statistical support groupUsing design of experiments, increased yields of lens blanks from 60% to 99%.Redesigned manufacturing processes to give over $1,000,000 a year in labor savingsPolymerization processMaterial handling process

Responsible for design of QA system and QC laboratory support for a controlled environment, device manufacturing facilityWrote technical sections for original CIBA PMAA for Atlanta facility.Completed all initial validations for USP water system, environmental controls and sterilization for original facility approval by FDA.Set up original product stability.

of QC - Directed operations QA at three sites that produced drug products manufactured in compliance with 21 CFR 210/211Lead project to convert contact lens accessory production from 21CFR 210/211 to the new medical device regulations, 21 CFR 820 requirements Recruited and trained original QA department