Combo Pack of 4 Training courses on FDA Rules and Regulations for Medical Devices

The medical device industry is facing increasing inspections from FDA and existing rules are being updated frequently. It is therefore vital for device industry professionals to ensure their operations and procedures are in compliance, in order to avoid penances and worse.
Instructor: David R Dills, Dr David Lim
Product ID: PACK70004

This package of 4 webinar recording CDs covers those issues that can be the biggest regulatory hassles for the medical device industry.


CD/Recorded-How It Works:

  • Webinar CD/Recorded will have a series of modules. Our experts have delivered the modules using PowerPoint Presentations.
  • Webinar Recording Link or CDs are licensed to be used multiple times at any location with multiple attendants, as you wish.
  • Recording links will be valid up to 6 months with unlimited access and reference materials will be mailed to your registered e-mail.
  • Free shipment of CDs within 72 hours from the date of purchase and reference materials will be mailed to your registered address.

Webinar Topics:


Who will benefit?

These webinar will be beneficial to the following:

Regulatory Affairs Managers Directors and VPs | Clinical Affairs Managers Directors and VPs | Quality Managers, Directors and VPs | Sales and Marketing Managers, Directors, and VPs | Complaint Handling and Risk Management Managers and Directors | Senior and Executive Management | Compliance Officers and Legal Counsel | R&D (Engineers, Scientists, Managers, Directors or VPs) | Product and Development (P&D) Managers, Directors and VPs | Site Managers, Directors, and Consultants


Webinars included in the Package:

FDA's Proposed Rule Regarding Device Establishment Registration and Listing and How to Register and List (Duration: 60 Minutes)

Device firms, establishments or facilities that are involved in the production and distribution of medical devices intended for use in the U.S are required to register annually. Most establishments that are required to register with the FDA are also required to list the devices that are made there and the activities that are performed on those devices.

Areas Covered in the Webinar:

  • When and how to register and list
  • Review the four proposed changes to FDA’s device establishment registration and device listing regulations
  • Proposed changes to Implement the provision of Bioterrorism Act applicable to imported devices
  • Other proposed Amendments that would change current device establishment registration and listing requirements
  • Replacement of the current regulations regarding updating device listing information outside the required update periods
  • Clarification of who must provide establishments’ registration numbers

Instructor Profile:

David R. Dills Regulatory Affairs & Compliance Consultant currently provides regulatory affairs, compliance and quality consultative services for medical device, pharmaceutical and biotech manufacturers on the global landscape, and also has an accomplished record with more than 24 years of experience with Class I/II/III medical devices, In Vitro diagnostics, and pharmaceuticals in the areas of Regulatory Affairs, Compliance and Quality Systems.


Quality Management Systems for Medical Devices and IVDs (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…"

Areas Covered in the Webinar:

  • 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

About the Instructor:

Dr David 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.,


Implementing Medical Device Reporting (60 Minutes)

In the United States, since December 13, 1984, the Food and Drug Administration (FDA) Medical Device Reporting (MDR) regulations have required firms who have received complaints of device malfunctions, serious injuries or deaths associated with medical devices to notify FDA of the incident. MDR is the mechanism for the FDA to receive significant medical device adverse events from manufacturers, importers and user facilities, so they can be detected and corrected quickly. To achieve compliance and to remain compliant, it is critical to understand how to define, document and implement the procedures for MDR to survive FDA inspections - avoiding FDA 483s and warning letters.

Areas Covered in the Webinar:

  • Applicable Statues, US Codes, and MDR Regulations
  • Definitions
  • MDR Regulatory Requirements
  • MDR Standard Operating Procedures (SOPs): Required Elements
  • MDR Criteria
  • Determining and Reporting MDR Events
  • Reporting Requirements for the User Facilities, Manufacturers, and Importers
  • Enforcements: Case Studies

About the Instructor:

Dr David 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.,


Implementing a Unique Device Identification (UDI) system (60 Minutes)

Congress passed legislation directing the FDA to develop regulations establishing a unique device identification system for medical devices. The UDI final rules are intended to establish a system to adequately identify devices during use and distribution. According to the finalized UDI rules, most medical devices distributed in the US are required to carry a Unique Device Identifier unless subject to an exception or alternative placement. The UDI system requires each device and each package to carry a UDI, the UDI of which should be provided in a plain text and in a form usable by automatic identification and data capture (AIDC) technology.

Areas Covered in the Webinar:

  • Applicable Statute(S) and Regulations
  • Definitions
  • UDI Development History
  • UDI Final Rules: Technical Requirements and Changes Made
  • When to Use a UDI and When to Discontinue Its Use
  • UDI System Requirements including Technical Standards
  • Requirements for a Unique Device Identifier
  • FDA Accreditation Process for an Issuing Agency including Suspension and Revocation
  • UDI Rules: Applicability
  • UDI Rules: Exceptions and Alternatives
  • Compliance Dates for the Applicable Requirements Over Seven (7) Years
  • Device Identifier Formats including Dates
  • Global UDI Database (GUDID): Technical Requirements (Data Format and Data Attributes)
  • Understanding Impact of the Final Rules to Many Business Areas/Processes
  • Changes in Device Design, Documentation and Manufacturing Processes
  • Practical, Actionable, and Sustainable Strategy: Good Practices to Adequately Implement a UDI System
  • Speaker’s Practical Tips.

About the Instructor:

Dr David 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.,

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