4 Need of the Hour Training courses on Medical Device Quality Systems Manual: FDA Inspections (4 Courses)

An FDA inspection is important. The investigator will evaluate your ability to comply with the regulatory requirements. A negative determination could affect your ability to sell products in the United States. It also could color all of your dealings with the agency as well as your relationship with partner companies and stockholders. There are numerous publications that regulatory and quality officials should read to prepare for an inspection. This article will cover the ones that I believe are required reading.
Instructor: Betty Lane, Ron Schoengold, Peter Spath, David Lim
Product ID: PACK70015

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Webinar Topics:


Who will benefit?

These webinar will be beneficial to the following:

Quality Professionals | Compliance Staff and Officers | Regulatory Affairs | R&D | Manufacturing managers, supervisors & personnel | Senior management executives (CEO, COO, CFO, etc.) | Project Managers | Design Engineers


Webinars included in the Package:

ISO 14971:2012 - Does your current Risk Analysis still comply with your CE Mark requirements (Duration 60 minutes)

This presentation will provide information on how to review your current risk analysis to make sure you fully comply with the requirements for Risk Analysis under EU Directive 93/42/EEC on Medical Devices and the other European Medical Device directives.


Objectives of the Presentation:

  • What is ISO 14971
  • How ISO 1497:2012 differs from ISO 14971:2007
  • How to update your Risk Analysis to meet continued compliance to the European Medical Device Directive(MDD)
  • How to make sure your Risk Management procedure assures you can meet your CE mark requirements for Risk Analysis

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.


Risk Management for Medical Devices: ISO 14971:2007 (Duration 60 minutes)

The company is required to implement a risk management program as an integral part of its quality system. A robust risk management program identifies and manages hazards throughout the product lifecycle. Once identified, hazards must be eliminated or mitigated to achieve the highest possible level of product safety and effectiveness. The company depends on its risk management program to continuously monitor and evaluate potential hazards associated with its products, and to take appropriate actions designed to lower the probability of harm to stakeholders.


Objectives of the Presentation:

  • Understand how to manage risk to promote product safety and effectiveness
  • Comply with current standards and regulations
  • Make better project management decisions
  • Provide exposure to basic risk modeling tools
  • Promote customer confidence

Instructor Profile:

Ronald Schoengold has been an active contributor to the medical device, pharmaceutical and biomedical environment for over 45 years. As a consultant to both large and small companies, he offers expert advice on quality systems, regulatory submissions and resolution of regulatory and quality problems. He is also an experienced auditor in clinical research, supply chain and manufacturing (CGMPs).


ISO 13485 Quality Management System (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.


Implementing an Internal Audit Program Pursuant to ISO 13485 and 21 CFR Part 820 (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

Instructor Profile:

Dr. David Lim is President and Principal of Regulatory Doctor. Regulatory Doctor provides Practical, Actionable, and Sustainable Solutions in an Integrated, Thorough ("PASS-IT") manner. 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,


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