Regulatory Inspections and How to Manage Them
Regulatory Inspections and How to Manage Them
You are Invited to an Evening Meeting
and How to Manage Them
Orange County Regulatory Affairs Discussion Group (OCRA)
Wednesday, November 5, 2014
5:30 – 9:00 pm
HORIBA Medical, 9755 Research Drive, Irvine, CA 92618
Azita Hedayati, MS, CMQ/OE, CQA, Director, Regulatory & Compliance, HORIBA Medical
Program Manager and Speaker:
Gustavo Kobrin, President Strategic Regulatory Solutions, Inc.
Panel Manager- Kim Walker, MS, RAC (US & EU), Global RA & QA Consultant, Kim Walker Consulting
Trudy R, Papson, Principal Consultant, Regulatory Consultants Group and Former FDA Investigator
Deborah Madsen, PE, Madsen Quality and Regulatory Consulting and Former Notified Body Auditor
This program is intended to provide information on regulatory inspection types and how to manage them.
Regulatory agencies, such as the FDA, Notified Bodies and Registrars inspect industry to ensure conformity of your practices for the purpose of establishing compliance to applicable regulations. Regulated companies are inspected on a routine basis both domestically and on the international level. Some inspections are considered “for cause” if there are circumstances which require an unannounced inspection.
A company’s goal is to effectively manage an inspection and to reduce the impact on the company’s operations. The goal of the regulator is to ensure public health and safety. They are concerned with enforcing and obtaining voluntary compliance with laws and regulations, protecting consumers from products that are impure, harmful, ineffective, improperly labeled, or in some other way dangerous, defective or deceptive.
Please join us in an informative and practical forum as we discuss how to manage an inspection, FDA-483s, Warning Letters and Notified Body Reports. We will also cover NCR best practices and how to manage them. Hear from an expert panel in regard to true war stories and how they were managed and resolved.
REGISTRATION DEADLINE: October 31, 2014
No on-site or walk-in registrations will be accepted for this program.
Space is limited at this facility and registrations will be accepted on a first-come-first-serve basis.
5:30 pm Registration, Networking and Dinner
6:00 pm Program Opening
6:05 pm Inspection Processes, Preparation and Management
6:30 pm Managing resolution of inspection findings and other post-audit activities
7:00 pm Break
7:10 pm Case Studies and Panel Discussion
8:30 pm Q&A
9:00 pm Adjourn
Gustavo “Gus” Kobrin, President of Strategic Regulatory Solutions, Inc. (SRS)
Gustavo Kobrin has been a quality assurance and regulatory compliance consultant since 1998. His company, Strategic Regulatory Solutions, Inc., specializes in international and domestic regulatory affairs, regulatory compliance including product registrations, regulatory inspection management, quality system development, auditing, and project management.
Gus is a Notified Body Auditor (ISO9001:08, EN ISO13485:12, CMDCAS and MDD (93/42/EC)), Certified Quality Auditor (CQA) and Certified Regulatory Affairs professional (RAC) with more than 35 years of experience in the medical device industry. Mr. Kobrin has assisted numerous medical device companies, from the very small to multi-national corporations. He is a long time member of ASQ and RAPS. He has served on the OCRA Program Committee and on its Board of Directors. Kobrin holds a Bachelor of Science degree from the University of California, Irvine.
Deborah Madsen, PE, Quality Systems and Regulatory Compliance Consultant
Deborah has been working in the medical device and in-vitro diagnostic industries for over 28 years. Deborah as held several roles at UL (a Notified Body) including regional lead reviewer, lead auditor, instructor/trainer, auditor qualifier, technical support for medical regulatory sales, and technical file assessor. She served as regional lead reviewer with responsibility for reviewing audits performed by other staff members and making certification decisions as well as determining whether companies were eligible for registration. She conducted audits as lead auditor in accordance with ISO 9001, ISO 13485, implementation of HC CMDR requirements under CMDCAS program, Medical Device Directive (93/42/EC), In Vitro Diagnostic Directive (98/79/EC), ISO 14971, and IEC 62304.
Prior to her work at UL, she spent eight years at a leading manufacturer of in vitro diagnostic and laboratory equipment, where she was responsible for worldwide product safety, EMC compliance, quality systems and regulatory compliance. Deborah also served as standards developer, U.S. technical expert, and member of IEC TC66 (laboratory equipment, IEC 61010-1) and contributed to development and revision of IEC 61010-1. Served as convener for IEC TC66 WG10 (centrifuges) and TC 66 WG11 (in vitro diagnostic equipment). Led development and issuance of IEC 61010-2-020, IEC 61010-2-089, and IEC 61010-2-101.
Deborah holds a degree in electrical engineering from the University of Illinois – Urbana and is a Registered Professional Engineer.
T.R. “Trudy” Papson, Principal Consultant, Regulatory Consultants Group
Trudy Papson is co-founder of Regulatory Consultants Group (RCG) and former FDA Investigator with the U.S. FDA, Los Angeles District Office.In her career at the FDA, she conducted hundreds of high profile, compliance follow-up and for-cause medical device inspections. Her experience also includes conducting pre-approval inspections, medical device pre-market/post-market approval inspections and BIMO inspections of clinical investigators and sponsor/monitors.
She received the Department of Health Services highest awards as a Medical Device Investigator. As Recall Coordinator she oversaw and worked with industry on serious public health threats and related problems with international significance. Papson is the recipient of numerous awards by the FDA for service and excellence.
Kim Walker, MS, RAC (US & EU)
Kim Walker, MS, RAC is an independent Global Regulatory Affairs and Quality Assurance Consultant and an owner of Kim Walker Consulting since 2006. In her consulting practice, she assists clients with pre- and post-market regulatory and quality system needs. Her work experience includes environmental chemistry, veterinary science, blood banking, clinical laboratory science, infectious disease assay research, microbiology, surgical assistant, IVDs, biologics, pharmaceuticals, combination products, and medical devices in university, start-up company, and large company environments.
Kim has served on the Orange County Regulatory Affairs Discussion Group (OCRA) Program Committee since 2003. Additionally, she served on the OCRA Board of Directors 2004-2010 and was the 2008-2009 President. Kim participated on the CLSI Point of Care Testing, Quality Systems, EP9, and Process Improvement working groups and was listed as one of the authors for CLSI GP22-A3. Quality Management System: Continual Improvement. She has managed, presented at and/or moderated at several professional conferences and educational institutions on clinical, regulatory, and quality topics. She also has participated in the SDRAN Mentoring Program since 2009. Kim participated on the CSUPERB Advisory Committee and Development Team for the Project Management in Clinical Trials certificate program through the California State University system. She was the instructor for the “Pre-Market Submission” course and co-instructor for the “Regulatory Requirements for Medical Products” course in the certificate program. Kim was also an instructor for the “Regulatory Requirements for Pharmaceutical Products” course and a co-instructor for the “Technical Writing for the Medical Product Industry” course at the University of California Irvine Extension. She achieved both the US and EU RAPS Regulatory Affairs Certifications. Kim received the 2008 Leonard Stauffer Award from RAPS in recognition of her contributions to mentoring and furthering regulatory professional education development.
She graduated from Auburn University with a Bachelor of Science degree in Bio-Medical Sciences and graduated with a Master of Science degree in Regulatory Affairs from San Diego State University.
OCRA Members: $50
Non Members: $100 (includes OCRA Membership for one year)
Government and Students: $25
FREE for HORIBA Employees (please email Azita to be added to the list)
Registration fee includes light dinner, beverages and parking.
After the meeting, electronic access to any approved presentations will be made for all attendees.
Dress code is business casual.