Speakers for the webinar series:

Dr. David Lim, Peter Spath, Betty Lane, Les Schnoll, Dennis L. Gorectke

Internal auditing is fundamental to any quality improvement initiative. FDA Quality System Regulation for Medical Devices requires that an organization conducts internal quality audits to determine the effectiveness of its quality system.

This package explicates complete guidance on developing an effective quality management and internal auditing system for medical devices.

Webinar Topics:

• Quality Management Systems for Medical Devices and IVDs
• ISO 13485 Quality Management System
• Implementing an Internal Audit Program Pursuant to ISO 13485 and 21 CFR Part 820
• How Create a Value-Added cGMP & ISO 13485 Internal Auditing System
• Quality System Regulation, Subpart G: Production and Process Controls
• ISO 13485 and Regulatory Affairs Training

Quality Management Systems for Medical Devices and IVDs (8:00 am- 9:00 am Duration: 60 Minutes)

FDA states in warning letters "this inspection revealed that these devices are adulterated within the meaning of section 510(h) of the FD&C Act, in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the 21 CFR Part 820…"

Objectives of the Presentation:

• US quality system regulations, flexibility, definitions and quality system requirements
• Management responsibility, audits and personnel
• Design control: design and development planning, design input, design output, design review, design verification, design validation, design transfer, and design changes
• Design history file (DHF) and device master record (DMR)
• Quality system procedures, purchasing controls and servicing
• Inspection, measuring and test equipment
• Process validation
• Corrective and preventive action (CAPA) and complaint files
• Quality requirements for premarket approval (PMA) application
• Case studies and lessons learned

Instructor Profile:

Dr. Lim obtained his Ph.D. in biological sciences at the University of Missouri-Columbia and published his thesis research in the prestigious journal "Science." Since then, Dr. Lim has held various positions at Duke, Caltech, US National Laboratories, Intrexon Corporation, Terumo, US FDA/CDRH, and EraGen Biosciences, Inc., A Luminex Company. In 2009, Dr. Lim served as a panel member during the FDA’s Transparency Public Meeting. Prior to founding his own consulting firm (www.RegulatoryDoctor.com), Dr. Lim was Senior Vice President of Scientific and Regulatory Affairs at Aquavit Pharmaceuticals, Inc. in New York. Dr. Lim as Regulatory Doctor provides practical, actionable and strategic solutions integrated with emotional intelligence (EQ) skills for all aspects of global regulatory, quality, clinical and compliance matters.

ISO 13485 Quality Management System (9:00 am-10:00 am Duration: 60 Minutes)

Organizations wishing to market Medical Devices in Europe must develop Quality Management Systems in accordance with ISO 13485. Such Quality Systems will also be beneficial for organizations seeking to gain marketing permission from the FDA. ISO 13485 is becoming the de facto international regulatory requirement for Medical Device manufacturing. Introduced in Europe as one of the requirements to obtain CE Marking for products, it has also gained acceptance within the FDA.

Objectives of the Presentation:

• Overview of ISO 13485 Quality Management System
• Discussion of key requirements
• What written procedures and training are required
• How should internal audits be conducted
• Understanding of what auditors expect

Instructor Profile:

Peter Spath is currently a freelance consultant serving the Medical Device community by providing a variety of quality and regulatory consultation on contractual basis remotely and on-site. Services include: leading Quality System audits in accordance with ISO 9001, 17025, and 13485, Canada's CMDCAS regulations and FDA GMPs for both Medical Devices and Combination Devices. He has over 20 years of experience working with international regulations and standards as a Certified Lead Auditor.

Break:- 10:00 am-10:30 am

Implementing an Internal Audit Program Pursuant to ISO 13485 and 21 CFR Part 820 (10:30 am-11:30 am Duration: 60 Minutes)

This webinar is intended to help you get familiar with how to establish an internal audit program of the quality management systems (QMS) for medical device manufacturers in preparation for an FDA inspection or for those who are subject to ISO 13485 and/or 21 CFR Part 820.

Objectives of the Presentation:

• Statutes and Regulations
• Definitions
• Comparative Overview of both ISO 13485 and 21 CFR Part 820
• Auditing Strategy
• Audit Objectives
• Audit Planning, Frequency, Duration and Logistics
• How to Audit Quality Management Systems
• Various Audit Approaches
• Quality Systems and Subsystems in ISO 13485
• Quality Systems and Subsystems under 21 CFR Part 820
• FDA and ISO 13485
• Good Practices: Speaker’s Suggestions and Recommendations
• Conclusion

Instructor Profile:

Dr. Lim obtained his Ph.D. in biological sciences at the University of Missouri-Columbia and published his thesis research in the prestigious journal "Science." Since then, Dr. Lim has held various positions at Duke, Caltech, US National Laboratories, Intrexon Corporation, Terumo, US FDA/CDRH, and EraGen Biosciences, Inc., A Luminex Company. In 2009, Dr. Lim served as a panel member during the FDA’s Transparency Public Meeting. Prior to founding his own consulting firm (www.RegulatoryDoctor.com), Dr. Lim was Senior Vice President of Scientific and Regulatory Affairs at Aquavit Pharmaceuticals, Inc. in New York. Dr. Lim as Regulatory Doctor provides practical, actionable and strategic solutions integrated with emotional intelligence (EQ) skills for all aspects of global regulatory, quality, clinical and compliance matters.

How Create a Value-Added cGMP & ISO 13485 Internal Auditing System (11:30 am-12:30 pm Duration: 60 Minutes)

Internal audits are required by both the FDA and ISO 13485. This webinar will cover creating of a Risk-based an internal auditing program for compliance to FDA and ISO 13485 internal auditing requirements. It will include how to set up and manage the auditing system, as well as an overview of how to conduct an internal audit, and document the results. It will discuss the value of a good internal auditing program in reducing compliance risk of all types.

Areas Covered in the Webinar:

• Learn How to develop or streamline and internal auditing system based on the principles of risk management but is still compliant to FDA cGMP/ Quality System Regulation and ISO 13485
• Know the difference between internal and external audits
• Understand what skills are required for an internal auditor
• Learn how the internal auditing system can add value to your quality system and your company
• Understand what the FDA must see to verify that you are conducting your internal audits as required

Instructor Profile:

Betty Lane has over 30 years’ experience in Medical Device quality assurance and regulatory affairs. She is the founder and President of Be Quality Associates, LLC, a consulting company helping small and medium sized medical device and diagnostic companies implement and improve their quality systems. Her work enables companies to manage their business in compliance with FDA and ISO 13485 requirements, as well quality system requirements for other area such as Europe and Canada.

Break:- 12:30 pm-1:00 pm

Quality System Regulation, Subpart G: Production and Process Controls (1:00 pm-3:00 pm Duration: 120 Minutes)

The Quality System Regulation (QSR) Subpart G defines the requirements for Production and Process Controls. The FDA's Quality System Inspection Technique (QSIT) inspectional methodology "divides" the requirements for medical device manufacturers into seven subsystems; two of those are the Production and Process Controls subsystem and the Equipment and Facilities Controls subsystem, both of which are contained in 21 CFR 820 (Subpart G).

Areas Covered in the Webinar:

• An overview of the Quality System Inspection Technique
• Production and Process Controls regulatory requirements
• Relationship of the Production and Process Controls subsection to the Equipment and Facilities Control subsection of the Quality System Regulation

Instructor Profile:

Les Schnoll has extensive experience in quality assurance, quality control, auditing, regulatory compliance, management, and microbiology in the medical device, pharmaceutical, and clinical/pre-clinical industries. Schnoll is recognized for achievements in developing value-added quality management and regulatory compliance systems. He is recognized by the Medicines and Healthcare Products Regulatory Agency (MHRA) (formerly the Medical Devices Authority) in the United Kingdom to perform assessments to the European Union Medical Device Directive and the European sterilization standards.

Break:- 3:00 pm-3:30 pm

ISO 13485 and Regulatory Affairs Training (3:30 pm-5:00 pm Duration: 90 Minutes)

The Webinar will extensively cover comparison of various QMS Objectives, Objective of ISO 13485:2003, how to set out requirements for a QMS that is capable of consistently meeting customer requirements, including regulatory requirements. The speaker will also speak about the objectives of ISO 9001:2008 and how to set our requirements for a voluntary, generic QMS that is capable of meetings customer & Regulatory requirements, and enhancing customer satisfaction through processes including continual improvement. The webinar will also enhance your knowledge on objective of the FDA Quality System Regulation and how to set our requirements for a QMS that is capable of consistently providing safe and effective medical devices.

Areas Covered in the Webinar:

• Management Review
• Document Control
• Internal Audit
• Control of Nonconformance
• Corrective & Preventive Action

Instructor Profile:

Dennis L. Gorectke has an entrepreneurial spirit having Run ISO Documents & Six-Sigma Consultants very successfully since 1992. He did ISO 9001 Training for the SBDC and UW Whitewater for five Years. He has worked for the Corporate Headquarters Quality Departments of Harley-Davidson Company, Johnson Controls and the Ford Fairlane Training & Development Center in Dearborn Michigan. All these Positions were as a Consultant & Trainer.

Who will benefit?

These webinar will be beneficial to the following:

R&D and Manufacturing Managers, Managers (RA & CA), Consultants, Contractors and Subcontractors, Regulatory Managers/Personnel, Manufacturing Managers, Supervisors & Personnel, Internal Auditors, Senior Management Executives (CEO, COO, CFO, etc.), Project Managers, Clinical Affairs, Anyone Interested in the Topic for ISO 13485 or 21 CFR Part 820, Audit Managers, Quality Management (QA & QC), Supplier Auditors, Quality Engineering, Legal Professionals