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Audits, Inspections, & Warning Letters – Best Practices
August 27, 2020 @ 6:00 pm - 8:30 pm$20 – $55
Audits, Inspections, & Warning Letters – Best Practices
How to Avoid Compliance Pitfalls
2.5 Hours Towards Your RAC Recertification
August 27, 2020
6:00 pm – 8:30 pm
Susan Bain, DRSc, Assistant Professor, Regulatory & Quality Sciences, USC
Kim Walker, MS, RAC (US & EU), FRAPS, Global Regulatory, Quality, & Clinical Consultant
Speakers & Panelists:
- Laura Guy, M.S., RAC, Principal, Regulatory Liaisons, LLC
- Jeff Yuen, MPH, MBA, President and CEO, Jeff Yuen & Associates, Inc.
- Raymond W. Brullo, DPM, Compliance Officer, ORA, Office of Medical Devices and Regulatory Health (OMDRHO), Division 3/West, FDA
- Salman T. Raza, Principal Consultant, Principal Auditor (designated by IRCA) / Lead Auditor for NB, Razalution Bureau
With FDA inspections, MDSAP audits, and ISO audits, the challenges of responding appropriately to the agency or ISO registrar are a constant balancing act for all medical product manufacturers. The key is addressing observations and compliance issues quickly and comprehensively. This program will present best practices for managing these compliance pitfalls and current FDA Warning Letter trends and perspectives on industry best practices. A panel consisting of FDA and industry representatives will provide insight on best practices in providing responses to FDA and ISO registrars and avoiding enforcement actions. Come spend the evening with us and build your confidence in interacting with the FDA and ISO registrars during an inspection/audit and in writing effective responses.
- OCRA Members: $55
- Non-Members: $130, includes 1-year OCRA membership
- Government and Student Members: $20, with student/government ID
- Non-Member Government and Student Rate: $55, includes 1-year OCRA membership
Schedule of Presentations:
6:00 – 6:30 pm cGMP Audits & Inspections – Best Practices, including MDSAP
Speaker: Laura Guy, M.S., RAC, Principal, Regulatory Liaisons, LLC
6:30 – 7:00 pm Warning Letter and Audit Response – Best Practices
Speaker: Jeff Yuen, MPH, MBA, President and CEO, Jeff Yuen & Associates, Inc.
7:00 – 7:30 pm FDA’s Perspective – Warning Letter Trends and Best Practices
Speaker: Raymond W. Brullo, DPM, Compliance Officer, ORA, Office of Medical Devices and Regulatory Health (OMDRHO), Division 3/West, FDA
7:30 – 8:25 pm Panel Discussion
– All of the speakers
– Salman T. Raza, Principal Consultant, Principal Auditor (designated by IRCA)/Lead Auditor for NB, Razalution Bureau
8:25 – 8:30 pm Closing Remarks
Speaker and Panelist Bios
Laura Guy, MS, RAC, has over 30 years of experience in regulated industry. Her Company, Regulatory Liaisons, LLC provides Regulatory Affairs and Quality System compliance services to innovators and manufacturers of pharmaceutical (Rx and OTC), biologic, cosmetic, and medical device products (including IVDs). To support her clients, Ms. Guy establishes infrastructures that promote compliance with FDA/ISO/MDD/MDR/IVDR regulations and standards. Areas of expertise include establishing and supporting Quality Systems, training employees and GXP auditing. For regulatory submission such as INDs, NDAs, IDEs, and 510(k)s, she assists clients with regulatory strategy to promote practical and successful plans for introducing the product into the marketplace. With commercial products, focus shifts to ensuring products continue to meet their intended use, safety and effectiveness claims by analyzing and addressing complaints/customer feedback, CAPAs, adverse event reporting, postmarket surveillance and formulating responses to 483s and Warning Letters.
Jeff Yuen, MPH, MBA
Jeff Yuen & Associates, Inc.
PO Box 6026
Orange, CA 92863
Phone: 714 234-8430
Fax: 714 685-0214
CDR Jeff Yuen is a well-respected domestic and international speaker with over 32 years of compliance and regulatory experience; Jeff was a peace officer/investigator with the State of California, Food and Drug Branch and a Consumer Safety Officer for the US FDA. During his tenure with the US FDA, he was rapidly promoted to the rank of Commander in the US Public Health Service while serving as a member of the following teams:
- FDA’s Pacific Regional Biotech Team (pre-cursor to ORA Team Biologics);
- Los Angeles District Pre-Approval Manager and Drug Team Leader; and
- Foreign Inspection Cadre.
CDR Yuen served as District Drug Team Leader and Drug Pre-Approval Manager during his time with US FDA. CDR Yuen specialized in both high priority drug (PAI) and biologics (ELA and BLA) inspections. He is widely recognized as a CGMP and compliance expert by industry, CDER and CBER Office of Compliance in the area of sterile drug manufacturing particularly with regard to inspection of biotech products, aseptic filling, quality systems, and process validation.
CDR Yuen is the recipient of numerous US Public Health commendation and achievement medals including a “Hammer Award” presented by Vice President Al Gore’s Office for his participation and leadership in the area of innovative biotechnology/FDA industry outreach programs. Since leaving the FDA in 1998, CDR Yuen has succeeded in launching a well-recognized and well-respected independent consulting firm. Jeff Yuen & Associates, Inc. is comprised of a unique balance between former FDA National Experts, specialists, investigators, chemists, biologists and microbiologists AND former industry quality systems, compliance and GXP regulatory experts.
Since leaving the FDA and building his well-respected consulting firm, he has served as an acting transitional executive at a number of companies: Head of Quality at Althea Technologies now Ajinomoto Althea (San Diego), Executive Vice President of Global Quality for AAI Pharma / Cambridge Major Laboratories now Alcami (North Carolina), Chief Quality Officer for Alexion Pharmaceuticals, Inc. (New Haven, CT) and Executive VP for Hanmi Pharmaceuticals (Korea).
CDR Yuen has become well-recognized worldwide for his unique ability to work well with others in Operations and QA. Well-respected for his mentoring, coaching and love for teaching, CDR Yuen excels at bringing out the best in companies. With a passion for operational excellence and performance, he has often served as the catalyst for organizational and cultural “change” resulting in effective quality systems which emphasize the importance of “right first time” and proper root cause investigations and meaningful CAPA initiatives. CDR Yuen’s leadership and insights along with his endless energy and special charisma have influenced, shaped and prepared many companies and their leaders for success during this challenging era of technological advancements and stricter compliance expectations.
Jeff Yuen & Associates, Inc. continues to be active in the following:
- Developing domestic and international regulatory and compliance strategies in the area of PAI/BLA and A/NDA PAI preparation, simulated FDA mock inspections,
- Conducting CGMP gap assessments,
- Conducting due diligence audits,
- Troubleshooting technical issues and interpreting compliance problems,
- Evaluating existing and future compliance risks and liabilities, and
- Providing CGMP training seminars.
CDR Yuen possesses a BS in Biological Sciences from UCI, a Masters in Public Health from UCLA, and an MBA from National University. CDR Yuen is a past President of the PDA – Southern California Chapter and former Board Member for the Institute of Validation Technology’s Journal of CGMP Compliance. Recently, CDR Yuen was awarded “Distinguished Alumni for the School of Biological Sciences – University of CA, at Irvine.
CDR Yuen sits on a number of executive advisory boards, remains a member of the BIOCOM’s FDA Committee, UCI’s Biotechnology Advisory Board, UCI Extension Advisory Board, and continues to teach at PDA-TRI. He has also been a member of PDA’s Biotech Technical Advisory Board.
Dr. Raymond W. Brullo, DPM (Ray Brullo) is in his 12th year as a Compliance Officer in FDA’s Office of Regulatory Affairs, Office of Medical Devices Radiological Health Operations, Division 3/West Compliance Branch. He is based in the FDA Los Angeles District Office, Irvine, CA.
He reviews case evidence for regulatory decision-making and interfaces with FDA’s Center for Devices and Radiological Health (CDRH) and Office of Chief Counsel. Previously, he was an FDA Investigator from 2002-2008.
Dr. Brullo attended Loyola University of Chicago, receiving a Bachelor of Science degree in Biology. He then attended the Rosalind Franklin University of Medicine and Science earning a Doctor of Podiatric edicine (DPM) degree. Post-Doctorate, he served a hospital and office-based foot surgery internship in Marshalltown, Iowa from 1983-1984.
He maintained a private foot and ankle medical and surgical practice from 1984-2002 in the Chicago area. Dr. Brullo’s areas of interest in his Podiatry career included: medical devices indicated for use in the lower extremity; complex wound care products; orthopedic implants; dermatology lasers; and peripheral vascular devices.
Salman T. Raza is a visionary and reformist at heart who has a passion for assisting companies and developing win-win partnerships. Through professional development and academics (MEng, MBA, MS) over the last decade he has conquered medical device regulations, management systems, strategy and organizational culture awareness. As the founder and Principal Consultant of Razalution Bureau, Salman assists medical devices companies for their business assurance compliance and helping them realize their potential by providing 360 degrees in services; i.e. from vision, strategy, management system development & training, regulatory strategy to effective team development through harmonized & productive work culture. Before establishing Razalution Bureau, Salman has worked in R&D, Manufacturing, QA/RA within medical devices industry and subsequently worked over a decade as Lead Auditor / Technical Reviewer for reputable European Notified Bodies including LRQA, SGS and LNE-GMED. Salman’s notable credentials include:
– Member of ISO 13485:2016 standard development technical committee TC 210 [During standard development phase between 2014-2016]
– Internationally recognized Lead Auditor by International Register of Certificated Auditors [IRCA] # 01195131
– Certified Regulatory Affairs Professional [RAC] # 09144585.
– MDSAP certified Lead Auditor
– Author of forthcoming book ‘Life’s Non-conformities – An Auditor’s Tale’
Razalution Bureau is a management system consulting and training firm specializing in global medical device regulatory compliance and business assurance. Our clients have come to trust us for our deep subject matter expertise and proven ability to deliver long-term results. Our fluency in regulatory requirements and improvement methodologies allows our customers to boost performance while safeguarding or improving their regulatory compliance. Our comprehensive solution is designed to help you achieve and maintain regulatory and commercial success. We facilitate our clients to:
- Understand /fine tune their vision, and identify their ‘value proposition’
- Formulate their short- and long-term competitive strategy
- Develop their management system
- Formulate (medical devices) regulatory compliance strategy
- Conduct regulatory and quality management system audits in accordance with ISO 13485;2016, MDSAP:2017 and MDD 93/42/EEC, MDR 2017/745 and IVDR 2017/746 etc.
- Technical Documentation Preparation for CE Mark assessment (medical devices).
Provide comprehensive customized trainings for global medical device regulations, quality management system (QMS) auditing, problem solving and soft-skills & organizational behaviour.
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