FDA Compliance Help Desk, Inc.

Walt Brittle is a sterilization process specialist that brings a wealth of experience to every project.  He rolls up his sleeves and gets the work done.  He has designed, implemented, and improved cGMP compliant quality systems; trained management and production staff, completed FDA warning letter recovery projects; and reviewed, submitted, and contributed to 510(k) applications for a number of firms.  He served four years in the clinical and surgical practice setting, followed by an extensive executive career with life science manufacturing, new product development, and contract engineering firms in North America, Europe, Japan, and Australia.

Project highlights:

·         Large Single Use Device (SUD) reprocessing firm, six-month engagement to address the following:

o   Ethylene oxide sterilization cycle failure investigation covering three years of device history sterilization records to identify and recommend corrective and preventive actions to conform with the following standards: ANSI-AAMI-ISO 11135 Sterilization of health care products—Ethylene oxide — Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices; TIR 14 Contract sterilization for ethylene oxide; TIR 15 Ethylene oxide sterilization equipment, process considerations, and pertinent calculations; TIR 16 Process development and performance qualification for ethylene oxide sterilization — microbiological aspects, and United States Pharmacopeia (USP).  Results: Recommended changes in load configuration, cycle parameters, process challenge device, cycle monitoring equipment, and biological indicator handling to eliminate cycle failure.

o   Retrospective review of Biological Indicator CAPA investigations. Results: Identified several deficiencies, made corrections, and developed a training guide for employees on how to investigate sterility cycle failures and process anomalies.

o   Review and correction of report files used to qualify two interim contract sterilization suppliers. Results: Identified a number of deficiencies and published a weekly punch list to employees assigned to provide the objective data needed.

o   Complaint file documentation review and correction project covering more than 300 files. Results: Corrections and letters to file were made.

o   Collaborative project with an associate consultant to develop a complaint handling/MDR training program for RA/QA management and complaint investigators. Results: Developed three-hour training class that integrated regulatory requirements, case study examples drawn from the firm’s complaint and MDR files, and instructor clinical experience. Post-training student evaluations scored the class 98.5 percent effective.

o   Coaching of staff managers in post-market risk assessment and failure modes, effects and criticality analysis (FMECA).

·         Sterile-fill saline and heparin flush syringe manufacturer, FDA Form 483 response project. Results: Revalidation, recommended facility changes—483 cleared.

·         Prescription drug packaging firm, warning letter remediation project supervising a team of three consultants. A 14-month assignment to independently conduct a cGMP audit, make quality system improvements, and manage the following:

o   Non-Beta lactam facility decontamination and requalification

o   Sampling and laboratory testing to develop objective data to demonstrate that a product recall is not necessary

o   Design and qualify a new beta lactam packaging facility

o   Employee training—validation, Title 21 Code of Federal Regulations (21 CFR Part 11), Electronic Records

o   Environmental qualification

o   Component and Labeling Records compliance to CFR 211.184 Component, drug product container, closure, and labeling records

·         Brittle also serves multinational clients as U.S. FDA registered agent, and import/export troubleshooter.

Call 919.942.1634

walt@FDAComplianceHelp.com