FDA Medical Device Industry Coalition

Transcription

1 Quality System Survival: Success Strategies for P&PC and CAPA 8:00 8:10 am Welcome, Housekeeping, How to get Q&A to Panel Reynaldo R. Rodriguez, District Director, Dallas Field Office, US FDA Reynaldo R. Rodriguez is the Dallas District Director. He has been in his current position since February Prior to this position he served as the Compliance Branch Director in Dallas, a Compliance Officer Supervisory Investigator and as an Investigator. He began his career with FDA in 1983 and has a wide breadth of inspectional and compliance experience across all FDA program areas. Ricky received his Bachelor of Arts degree in Biology and Chemistry from St. Mary s University, San Antonio, Texas in 1983 and received his Master of Arts degree in Public Administration from Webster University, St. Louis, Missouri in :15 8:45 am Regulation Overview: The Combined World of P&PC and CAPA 21 CFR , , , , , , , , John Criscione, M.D., Ph.D. Texas A&M University A distinguished member of the FMDIC board, Dr. Criscione received his BS in Applied Physics from Purdue University, and his MD and PhD from Johns Hopkins University. He currently serves as CTO for CorInnova Incorporated, a pre-clinical medical device company engaged in the development of a Cardiac Assist Device that uses minimally invasive technology. He also serves as Associate Professor of Biomedical Engineering at Texas A&M University. Dr. Criscione s research focuses on how mechanics the study of force and motion in matter applies to the biology of the heart and how to utilize such knowledge to obtain better clinical outcomes. Toward this end, state-of-theart modeling tools are essential for representing the mechanical behavior of biological tissues, and Dr. Criscione has made fundamental contributions to the non-linear field theories of mechanics.

2 8:45-9:45 am Getting it Wrong: Warning Letter Learnings Jeff R. Wooley, Compliance Officer, Dallas District, US FDA Jeff. R. Wooley has been a Compliance Officer for the FDA Dallas District Office since He currently performs medical device and drug inspections throughout the Dallas District Office area of coverage (Texas, Oklahoma, and Arkansas) and has conducted international inspections. He earned his Bachelor of Science Degree in Biology from Sam Houston State University in :45 am - 10:30 am Process Planning Strategies for Effective Monitoring and Control Cheryl Boyce, President of Boyce Consulting, ASQ CQA, RAPS RAC, RAB Certified Quality Management System Lead Auditor Cheryl Boyce, as Principal of Boyce Consulting, provides personalized, costeffective FDA and ISO regulatory and quality solutions and training to small and large companies, initial importers, contract sterilizers, laboratories and entrepreneurs. Ms. Boyce has successfully developed, managed and implemented systemic quality system corrective action plans which included all facets of the quality system requirements for multiple small and large medical device companies. During her tenure at FDA she received numerous awards for FDA Commendable Service, for Government Investigator of the Year, and was also nominated as FDA Investigator of the Year. During her FDA tenure, Cheryl Boyce provided expert technical assistance to FDA's Office of the Commissioner, Special Assistant for Investigations, and provided written and verbal recommendations to the commissioner and the commissioner's investigation staff regarding the quality of 510(k) s and investigation device exemptions and necessary corrective action. Ms. Boyce developed a Medical Device Training Program for other FDA investigators and provided training to FDA investigators in both the Dallas and Kansas City District FDA Offices. Ms. Boyce has served as an Expert Witness in a number of medical device cases, served as a trainer for AAMI for the QSR national training sessions, and published a number of training materials and audit handbook references, including Improving Process Quality through Variation Research. Ms. Boyce has a BS in Chemical Engineering from the University of South Carolina.

3 10:30-10:45 am 10:45-11:30 am 11:30 12:00 am BREAK Efficient Validation Strategies and VMPs Personnel Strategies: Effective Training and Selection BREAK Anne Wilson, CEO, QA Consulting, Inc. Mona Elkhatib, TMAC, UT - Arlington Anne Holland Wilson combines more than 25 years of biomedical engineering with business acumen as founder and CEO of QA Consulting, Inc. Under her guidance, QA Consulting has grown from a local Austin-based firm, founded in 2000, to one of the leading HUB and WBENC-certified medical device consulting firms with clients throughout the nation. She is an expert in every phase of quality assurance from design concept and R&D through manufacturing/ production, and post-market surveillance for Class I, II, and III medical devices. She holds a B.S. in Biomedical Engineering from Vanderbilt University in Nashville, TN, and an MBA from the University of Colorado in Denver, CO. Anne holds certifications as an ASQ Certified Quality Auditor (CQA), ASQ Certified Quality Engineer (CQE), ASQ Certified Quality Manager (CQM), RABQSA Quality System Lead Auditor, and Society of Quality Assurance Registered Quality Assurance Professional in Good Laboratory Practice. Mona Elkhatib brings over 15 years of experience in Process Improvements, Quality Management Systems and Assurance, Regulatory Compliance, Training and Auditing. In her role as a Lead Auditor for an accredited registrar, Mona has audited over 500 companies. Mona holds a Master of Science degree in Biomedical Engineering from the University of Texas Southwestern and a Bachelor of Science degree in Industrial Engineering from The University of Texas at Arlington. Mona is an ASQ Senior Member and is a Certified Quality Auditor (CQA) and Certified HACCP Auditor (CHA). She is an IRCA Certified Lead Auditor for ISO 9001, and ISO under Canadian Medical Device Conformity Assessment Scheme (CMDCAS) requirements. She has also completed the qualification and training requirements for the Medical Device Single Audit Program (MDSAP) sponsored by FDA

4 12:00-1:00 pm LUNCH 1:00-1:40 1:40-2:20 Managing Facility Expansions, Equipment Modifications and Continued Growth Rework Strategies: Effective Planning and Execution Robert Freeman. President, Practical Perspectives Al Alonso. CEO, Alonso Quality System Consulting President of Practical Perspectives, Robert is a recognized authority in the field of management systems centered on quality, environmental, occupational health and safety standards and transitional management. He is a member of US TAG 176, the group representing the United States position on ISO Robert has successfully assisted hundreds of organizations with their implementation and registration efforts. A quality and manufacturing practitioner for over 30 years, his industry experience includes electronics (commercial and military), hardware development, food products, telecommunications, software, medical devices, machining, sheet metal, distribution, cabling, packaging, injection molding, coatings & resins, and media duplication. Robert is a Registered Lead Assessor for ISO 9001, ASTD Certified in Organizational Training and Development. As owner of Alonso Quality System Consulting and a Senior Consultant with NSF Health Sciences, Mr. Alonso has over 40 years of experience in the Medical Device industry. Responsibilities include 25 years executive management experience in Quality Assurance, Regulatory Affairs and Clinical Affairs with cardiovascular and orthopedic implantable products at such companies as DJO Surgical, Sorin Biomedical and Sulzer Carbomedics.

5 2:20-2:50 Effective CAPA: Determinin g Appropriate Measures, Intervals and Evidences Raja Chatterjee, Director of Quality Assurance, Orthofix Inc. Raja has over 10 years of experience in the Medical Device industry and has worked in Product Development, Manufacturing, Regulatory Compliance and Quality Assurance roles. In his current role as the Director of Quality Assurance at Orthofix Inc., a spinal and orthopedic implant manufacturer, he oversees the US site quality activities for the company. Raja holds a bachelors and master s degree in Mechanical Engineering and is currently pursuing a law (JD) degree at SMU Dallas. 2:50-3:05 3:05-3:45 3:45-4:40 BREAK Verification of Corrections Lauren Skokan Priest, MSBE, Compliance Officer, Denver District, US FDA Lauren has over 7 years of experience as an FDA investigator. Her responsibilities include conducting inspections, investigations, and sample collections as part of the mission of the Office of Regulatory Affairs (ORA). Her main responsibilities include auditing medical device manufacturing firms, human tissue recovery and reproductive (In Vitro Fertilization) firms, and pharmaceutical manufacturers for adherence to Good Manufacturing Practices respective to each commodity for both domestic and foreign medical device manufacturing companies. To perform these inspections and investigations, she reviews and evaluates the manufacturing practices, data, and documentation describing firm processes and products to ensure both are in compliance with Federal laws and established regulations. Ms. Skokan has a B.A.Sc. in Biology from UT-Arlington, and a MSBE for UTA/UT- Southwestern Medical Center. PANEL DISCUSSION - Making it All Work/Attendee Q&A

6 4:40-4:50 4:50-5:00 Inputs for Future needs and desires Audience Survey Forms - Ricky Rodriguez Closing and Goodbye till 2018 Reynaldo R. Rodriguez, District Director, Dallas Field Office, US FDA