Conferences

Summary

In today’s global economy, every company in the pharmaceutical industry strives to achieve a pipeline with a steady stream of breakthrough products.

Medical Device and Diagnostic companies are no different but in order for these products to enter the global markets, the regulatory restrictions include the need for the company to have a compliant Quality System and not the least, a viable Product Development process.

The objective of these masterclasses is to provide you with a complete overview, and leave you with an understanding of all the important elements required for ISO 13485 and major FDA regulatory compliance for development of Medical Devices and In-Vitro Diagnostic Devices.

This is ”MUST-ATTEND” event for those who want to understand how to launch MDs / IVDs in key markets such as EU, US, Japan, Canada, Australia and Singapore. This is particularly so for new biomedical / biotech start-ups, dealing with everything from the design and manufacture to the sales and marketing of test kits, or for established companies wishing to consolidate, expand, improve and enhance their scope, concepts and knowledge, or simply, for the latest updates.

All the said guidelines seem “common-sense or easy enough” at first glance, or are they really? Classification, Interpretation and Experience are absolutely KEY in this area in order to be successful!

Learning Objectives

Key Benefits of attending the course:
 Understanding the Definitions & Regulatory Requirements for Medical Devices
  (MD) / In Vitro Diagnostics (IVD) of Key Markets (which include IS0 13485!)
 Know the various Classifications of MD/IVD
 Introduction to Medical Device Directive (MDD) / In Vitro Diagnostic Directive (IVDD)
 How to appoint EU Authorised Representative
 How to prepare Technical Construction File
 Realise what is ISO 9001 & 13485,  GMP, their versions & their differences
 Learn and know how to interpret ISO 13485 standards and general principles
 How to set up ISO 9001/13485 Quality Management System to achieve its Certification
 How to prepare for Product Certifications
 External and Internal Audit Preparation
 Management Review Meeting
 Learn through Industry Experience, Audited Templates and Case Studies

Speakers

Conference Agenda

Workshop Agenda

INTRODUCTION
Understanding the Philosophy behind ISO and GDPMDS
• Fundamentals of ISO 13485 and GDPMDS
• Differences between ISO 13485 and GDPMDS
• Top down approach and Management’s Responsibility
• Documentation and Record Requirements
• Identification and Traceability

MANAGEMENT RESPONSIBILITY AND RESOURCE MANAGEMENT
Quality Manual, Quality Policy, Goals and Objectives
• How to create a user-friendly/value-added Quality Manual
• Using your corporate vision to define your Quality Policy
• Setting clear and measurable Quality Goals/Objectives

Management Representative and Management Reviews
• Appointing an appropriate Management Representative
• Conducting effective Management Reviews

Personnel and Work Environment
• Evaluating employee competence and training needs
• Developing an effective training system
• General requirements for work environment and specific requirements for production and storage areas

PRODUCT REALIZATION
Product realization refers to all the processes that are used to bring products into being (i.e. a product starts out as an idea. The idea is realized or actualized by following a set of product realization processes)
Design and Development
• Fundamentals of Design Control
– Design Inputs and Ouputs
– The difference between design verification and validation
• Identifying and mitigating design risks
• Conducting effective Design Reviews
• Documenting design control activities
• Using contract developers - Who is responsible for design?

PRODUCT REALIZATION (continued)
Purchasing and Production Planning
• Planning, scheduling resources, and Purchasing
• Controlling outsourced activities and processes
• Developing an appropriate supplier evaluation process

Production Controls
• Difference between process verification and validation
• IQ/OQ/PQ – what these terms mean, and why they are important
• Conducting a Process FMEA
• Specific requirements for sterilized medical devices
• Calibration and Preventive Maintenance
• Service and Installation

Measurement, Analysis and Improvement
• Identifying and controlling nonconforming product
• Conducting root cause analyses and taking action (CAPA)
• Internal audits – value added versus “just a formality”
• Complaint handling and adverse events

GDPMDS Specific Requirements
• Field Safety Corrective Action (FSCA)
• Return and Disposal of Medical Devices
• Counterfeit, Adulterate, Unwholesome or Tampered Medical Devices

Pricing
(must register & pay by dates listed)