8 Important Webinar Courses on FDA Parameters for Device Industry

Success in the Medical Device industry requires cohesion to apposite FDA regulations. Rapid product development processes providing receptivity to changing market demands are key to meeting the requirement of this market. This pack contains some of our best selling Medical Device webinars which together cover the requisite compliance obstacles faced by Medical Device companies today.
Instructor: David Lim, Jeff Kasoff, David R Dills
Product ID: PACK70010

CD/Recorded-How It Works:

  • Webinar CD/Recorded will have a series of modules. Our experts have delivered the modules using PowerPoint Presentations.
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  • Recording links will be valid up to 6 months with unlimited access and reference materials will be mailed to your registered e-mail.
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Webinar Topics:


Who will benefit?

These webinar will be beneficial to the following:

CEOs and VPs | Clinical Affairs (Associates, Specialists, Managers, Directors or VPs) | Regulatory Affairs (Associates, Specialists, Managers, Directors or VPs) | Quality Professionals (Associates, Specialists, Managers, Directors or VPs) | R&D (Engineers, Scientists, Managers, Directors or VPs) | Complaint and Risk Management Personnel | Contractors/Subcontractors | Compliance Officers | Attorneys/Legal Counsel | Investigators | Marketing & Sales | Distributors/Authorized Representatives | Consultants


Webinars included in the Package:

Best Practices and FDA-Compliant Medical Device Reports (MDRs), Recall, Corrections and Removals (Duration: 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.

Objectives of the Presentation:

  • Relevant statutes and FDA regulations
  • Regulatory requirements for MDRs, recalls, corrections and removals
  • Definitions
  • How to report medical device adverse events
  • Reporting requirements for the user facilities, manufacturers, and importers
  • Recalls, corrections and removals (devices)
  • Voluntary recalls and mandatory device recalls
  • How to perform and document corrections and removals
  • Enforcements: case studie.

Instructor Profile:

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.,


Anatomy of a Medical Device Inspection: From EIR to 483 to Warning Letter (Duration: 60 Minutes)

Does the FDA call in advance or just show up at my door? Where do I let the inspector go? Do I give them a tour? What should I let them see? Who should I let them talk to? Are they ever going to leave? The FDA inspection is the most nerve-wracking event in the life of a regulatory professional - you're in charge of compliance, usually in the background, and NOW you're in the spotlight, and if your performance isn't good, it's not the show that may close, it's YOUR COMPANY!

Objectives of the Presentation:

  • How to prepare for an FDA inspection
  • Development and contents of an SOP for FDA inspection
  • Personnel training before inspection
  • How to behave during an inspection
  • Limitations of scope of inspection
  • Response to investigation findings
  • FDA guidance documents used by their inspectors.

Instructor Profile:

Jeff Kasoff, RAC, is the Director of Quality at Byrne Medical, a leading manufacturer of endoscopy and colonoscopy devices, where he oversees the operation of the quality system. In this position, Jeff is responsible for oversight of the document control system, including maintenance of regulatory documentation. Prior to this, Jeff spent 13 years at Life-Tech, Inc.


Best Practices Compliant with the FDA Regulations for Handling Medical Device Complaints (Duration: 60 Minutes)

Medical device manufacturers, device user facilities, and applicable stakeholders are required to establish and maintain adequate procedures for handling complaints. This webinar is intended to help you get familiar with the regulatory requirements and how to establish and maintain an effective complaint handling system applicable to all device types.

Objectives of the Presentation:

  • Legal authorities (statutes and regulations) and definitions
  • Regulatory requirements and compliance
  • Implementing applicable processes and procedures
  • What to do when a complaint is received
  • What/how/when to investigate a complaint
  • Contents of records of investigation
  • How to adjudicate the complaint
  • Implementing interactive systems between complaint handling, medical device reporting, and CAPA
  • Numerous case studies
  • Lessons learned

Instructor Profile:

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.,


Draft Guidance for Device Industry and FDA - Postmarket Surveillance (Duration: 60 Minutes)

This guidance document is being distributed for comment purposes only and will be of benefit for medical device manufacturers and the document was issued on August 16, 2011. Postmarket surveillance under section 522 of the Federal Food, Drug, and Cosmetic Act (the act).

Objectives of the Presentation:

  • Review proposed changes
  • Explain the legal background and overview of statutory criteria
  • Considerations regarding pediatric population provisions
  • Understand expectations for postmarket surveillance study duration
  • Describe the postmarket surveillance process and identification of issue
  • Why an order for postmarket surveillance will issued under section 522
  • Learn why postmarket surveillance study plans are reviewed as an original submission and its amendments until the plan is approved
  • Determine the elements to Include in a Postmarket Surveillance Study Plan
  • Understand why FDA may order postmarket surveillance to address a wide variety of device-related public health questions
  • Current expectations for different stages of Postmarket Surveillance Study Reports
  • Why happens if you fail to complete a Postmarket Surveillance Study

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.


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.

Objectives of the Presentation:

  • 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…"

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 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.

Objectives of the Presentation:

  • 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

Instructor Profile:

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.

Objectives of the Presentation:

  • 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.

Instructor Profile:

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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