Combo Pack of 4 Training Courses on FDA Rules and Regulations for Medical Devices - Research and Markets

DUBLIN--()--Research and Markets has announced the addition of the "Combo Pack of 4 Training courses on FDA Rules and Regulations for Medical Devices" webinar to their offering.

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.

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

Webinar Topics:

- FDA's Proposed Rule Regarding Device Establishment Registration and Listing and How to Register and List

- Quality Management Systems for Medical Devices and IVDs

- Implementing Medical Device Reporting

- Implementing a Unique Device Identification (UDI) system

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:

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

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

2. Quality Management Systems for Medical Devices and IVDs (60 Minutes)

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

3. Implementing Medical Device Reporting (60 Minutes)

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

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

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.

For more information visit http://www.researchandmarkets.com/research/cxcdpv/combo_pack_of_4

Contacts

Research and Markets
Laura Wood, Senior Manager
press@researchandmarkets.com
For E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
U.S. Fax: 646-607-1907
Fax (outside U.S.): +353-1-481-1716
Sector: Professional Development and Training, Medical Devices

Contacts

Research and Markets
Laura Wood, Senior Manager
press@researchandmarkets.com
For E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
U.S. Fax: 646-607-1907
Fax (outside U.S.): +353-1-481-1716
Sector: Professional Development and Training, Medical Devices