ComplianceOnline

Course Description:

In-vitro Diagnostics (IVD) products provide critical information on patient’s health condition, based on which the healthcare provider develops and administers treatment plan. Although IVDs are medical devices, they are regulated under a separate set of regulations in U.S., Europe, and Canada.

This 2 day interactive course on in-vitro diagnostics is structured to understand the different set of IVD regulations, how to navigate through this maze of IVD regulations, and to win regulatory approvals. This In-vitro Diagnostics (IVD ) course will make the attendees understand the IVD regulations and develop regulatory strategies that secure regulatory approvals.



Learning Objectives:

After completion of this two day interactive course on IVD, the attendee will be able to:

  • Understand why IVD is regulated differently.
  • An overview of IVD Regulations – U.S. FDA., Europe (MDD), Canada.
  • Develop Regulatory Strategies and determine Regulatory Pathways.
  • Inclusion and exclusion of data and information for different submission.
  • Format and Content of premarket submissions.
  • Product Label and Labeling for IVDs.
  • Working and interacting with the reviewers and regulators.
  • Tips and Suggestions to secure rapid regulatory approvals.


Who will benefit:

This interactive course is specifically developed for individuals, who are responsible for the design, development, manufacturing, marketing, and distribution of IVD products. This course is highly recommended for personnel involved in any of the following functions:

  • Department Managers (middle management)
  • Research & Development (R&D)
  • Product Design & Development
  • Validation Engineering
  • Regulatory Affairs
  • Quality Assurance
  • Quality Control
  • Manufacturing/Production




Day One (8:30 AM – 4:30 PM) Day Two (8:30 AM – 4:30 PM)

Registration Process: 8:30 AM – 9:00 AM

Session Start Time: 9:00 AM

Welcome and Introduction

UNITED STATES

Session 1: 09:00 AM – 10:30 AM

  • Evolving technologies and challenges of In-vitro Diagnostics (IVD) products
  • Why the regulators need separate regulations even IVD is considered a device?
  • Know the process and players at OIR (aka OIVD) of CDRH and Health Canada

Morning Break: 10:30 AM – 10:45 AM

Session 2: 10:45 AM – 12:15 PM

Overview of US-FDA Regulations for IVDs

Lunch Break: 12:15 PM – 1:15 PM

Session 3: 1:15 PM – 2:45 PM

  • Determination of classification & Identification of Predicate Device(s)
  • Development of Regulatory Strategies and Pathways for IVDs
  • Special consideration of IVD labeling requirements

Afternoon Break: 02:45 PM – 03:00 PM

Session 4: 03:00 PM – 04:30 PM

  • Determine the type of the required pre-market submission for your IVD
  • Format and Content of 510(k), Pre-IDE, IDE and PMA
  • What is a Clinical Laboratory Improvement Amendment (CLIA) of 1988?
  • Preparation and submission for CLIA Waiver Application

EUROPE

Session 5: 09:00 AM – 10:30 AM

  • Overview of European IVD Regulations
  • Understanding of EU MDD 98/79/EC for IVD and applicable MEDDEV documents

Morning Break: 10:30 AM – 10:45 AM

Session 6: 10:45 AM – 12:15 PM

  • Special consideration to Classification Rules for IVDs
  • Conformity Assessment for CE Marking
  • Special Labeling and electronic Labeling Requirements for IVDs
  • Preparation of Technical File or Design Dossier

Lunch Break: 12:15 PM – 1:15 PM

CANADA

Session 7: 1:15 PM – 2:45 PM

  • Overview of Canadian Medical Device Regulations (CMDR) for IVDs
  • Understanding similarities and differences between U.S. and Europe regulations

Afternoon Break: 02:45 PM – 03:00 PM

Session 8: 03:00 PM – 04:30 PM

  • Format and Content of Canadian Medical Device License (MDL) Application
  • Inclusion of the required data and information for MDL application
  • Conclusion & Summary of the course




Meet Your Instructor

Subhash R Patel
Regulatory Affairs & Quality Compliance Consultant at MD Reg Consulting, LLC

Subhash Patel is a seasoned and well-accomplished Regulatory Affairs and Quality professional with over 27 years of Global Regulatory Affairs experience in highly regulated medical device industry. Mr. Patel is a founder and owner of MD Reg Consulting, LLC offering services to medical device industry clients. He started his career as a Quality Engineer and climbed corporate ladder to the Director of Corporate Regulatory Affairs/QA of Fortune 500 medical device companies. During his professional journey he gathered wealth of practical knowledge and working experience with the global laws, regulations, and regulatory requirements for medical devices. His passion is to learn new challenges and share his knowledge and experience with others to succeed.

He is Regulatory Affairs Certified (RAC) and also honored as a RAPS Fellow by the Regulatory Affairs Professional Society (RAPS). He holds professional certificates in Medical Devices Regulatory Affairs Program, ASQ-Certified Quality Auditor (CQA) and ASQ-Certified Quality Engineer (CQE). His educational background includes BS degree in Mechanical Engineering and also BS degree in Chemistry.





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