Conference
Wednesday, June 4, 2008
9:00 A.M. - 4 P.M.
| Session 301 - Advanced Process Validation: Theory, Practice, Compliance |
Instructors: Richard DeRisio, Vice President of Global Regulatory Affairs, Advanced Medical Optics; Wayne Taylor, PhD, Founder and Chairman, Taylor Enterprises; and Jennifer Medicus, LT, USPHS, Biomedical Engineer, OC, CDRH, FDA 
- Introduction
- Establishing a companywide validation lifecycle
- Overview of general process validation concepts
- Standardization and regulation of validation
- Compliance issues associated with process validation
- Assessing your company’s state of validation
- Establishing a validation toolbox
- Developing a validation strategy
- Creating the validation master plan
- Implementing efficient design controls to assure effective validation processes
- Application of statistical techniques to process validation
- Commissioning and validation – leveraging the good business aspects of an effective
validation program
- Maintaining the company’s processes in the “state of validation”
- The validation infrastructure
- Incorporating risk management and risk assessment into process validation
- Validation regulations, standard and guidance documents
- FDA’s quality system inspection technique (QSIT) approach to inspecting validation
- FDA compliance issues associated with validation
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ABOUT THE INSTRUCTORS
Richard DeRisio, Vice President of Global Regulatory Affairs, Advanced Medical Optics
Mr. DeRisio is Vice President, Global Regulatory Affairs for Advanced Medical Optics, Inc. (AMO). Mr. DeRisio's organization is responsible for developing innovative regulatory strategies for obtaining and sustaining worldwide product approvals for AMO's medical products, and for assuring that advertising and promotional practices comply with regulatory requirements. AMO is a global company that develops and markets advanced vision technologies to improve vision and Quality of Life for patients of all ages. AMO product technologies comprise laser vision correction, intraocular lens implantation, phacoemulsification, and eye care solutions.
In previous companies including, among others, Kinetic Concepts, Inc., Johnson & Johnson and Pfizer, Mr. DeRisio had clinical, regulatory and quality responsibility for products including mechanical heart valves, defibrillators, electrophysiology catheters, wound healing systems, robotic surgery devices and sterilization equipment. His responsibilities have included clinical research, product approvals, quality assurance and compliance.
During a ten-year career at FDA in Washington, Mr. DeRisio worked in the Division of Field Operations in the Field Engineering Group and the Foreign Inspection Branch, and later in the Office of Compliance in the Center for Devices and Radiological Health.
Mr. DeRisio is a graduate of Cornell University, where he received a Bachelor of Science degree in chemical engineering and Master of Science degree in food science and technology with a minor in microbiology. He is a former member of the Board of Directors of AAMI and has served as an instructor in the FDA/AAMI GMP training course. Mr. DeRisio is a member of AAMI, AdvaMed, ASQ and the Regulatory Affairs Professional Society. He serves on the editorial advisory boards of Medical Device & Diagnostic Industry magazine and the Devices and Diagnostic Letter. His publications and presentations have addressed product approvals, quality systems, risk assessment, FDA inspection compliance and sterilization sciences.
Wayne Taylor, PhD, Founder and Chairman, Taylor Enterprises
Dr. Taylor is the founder and chairman of Taylor Enterprises, Inc. where he is responsible for the development of the VarTran®, Change-Point Analyzer, and Sampling Plan Analyzer software packages as well as providing consulting and training on the Six Sigma approach and tools including Robust Design, Tolerance Analysis, Design of Experiments, SPC, Acceptance Sampling, and Statistics.
In 2000, Dr. Taylor retired from his position as Director of Quality Technologies at Baxter Healthcare Corporation where he was responsible for Baxter's Six Sigma program. He and his staff have trained over 800 of Baxter''s engineers to serve as Six Sigma black belts. He had been with Baxter for 22 years.
He is author of the books Optimization and Variation Reduction in Quality and Guide to Acceptance Sampling. The first book outlines the approach implemented at Baxter for achieving six sigma quality. The second book outlines a simple to use approach for selecting and justifying sampling plans as well as reducing inspection costs that is used throughout the medical device industries. This system has saved Baxter over 30 million dollars annually.
Dr. Taylor is the leading expert on acceptance sampling in the pharmaceutical, medical device and diagnostics industries. His articles on selecting statistically valid sampling plans have become standards in the industry and are used by the FDA in their new inspector training. He has taught his 2-day course Successful Acceptance Sampling to over 5,000 students and 50 companies including the CDRH (Center for Devices and Radiological Health) of the FDA.
Dr. Taylor is also a leading expert in Process Validation. He is author of Annex A of the Global Harmonization Task Force guideline titled Process Validation Guidance for Process Validation Engineers.
The VarTran software and Dr. Taylor's course Robust Tolerance Analysis have rapidly become a key component of many companies DFSS (Design for Six Sigma) programs. Honeywell, the Six Sigma Academy and numerous other companies have adopted VarTran as an essential tool for designing high quality products.
He has made many key contributions to the field of Quality including Variation Transmission Analysis, Process Tolerances, Quick Switching Systems and Change-Point Analysis. He has dozens of articles and hundreds of presentations to his credit.
Dr. Taylor received his Ph.D. in Statistics from Purdue University. He is a fellow of the American Society for Quality and the Royal Statistical Society as well as a member of the American Statistical Association (ASA).
Jennifer Medicus, LT, USPHS, Biomedical Engineer, OC, CDRH, FDA
Jennifer Medicus is a Biomedical Engineer in the U.S. Food and Drug Administration's Center for Devices and Radiological Health, Office of Compliance, Division of Enforcement B, Orthopedic, Physical Medicine and Anesthesiology Devices Branch in Rockville, Maryland. As an engineer, she performs reviews of Quality System and manufacturing information from premarket approval (PMA) applications and supplements; reviews and evaluates recalls of medical devices; reviews establishment inspection reports of device manufacturers for compliance with Good Manufacturing Practice (GMP) requirements; and reviews and recommends regulatory actions.
Ms. Medicus received a Bachelor of Engineering degree in Biomedical Engineering from Vanderbilt University, Nashville, Tennessee, and a Master of Engineering degree in Biomedical Engineering from The Catholic University of America, Washington, DC.
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