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Course "Applying U.S. FDA Laws and Regulations to Each Phase of Total Product Life Cycle (TPLC)" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
Overview:
This workshop style training course is supported by comprehensive knowledge of U.S. FDA laws and regulations and 30 year of extensive experience working within in the U.S. FDA regulated industries. In these 2 days, the following essential topics will be covered:
Total Product Life Cycle and Your Medical Device
An Overview of U.S. FDA Medical Device Regulation
Regulations for Design and Product Development
Premarket Notification - 510(k) and Premarket Approval (PMA)
Regulations for Production & Process Control
Readiness for FDA Facility Inspection
Why should you attend:
The complex network of multilayer laws, regulations and regulatory requirements create confusion and misinterpretation that leads the device manufacturer into Non-compliance state. Non-compliance to applicable laws and regulations results into severe penalties or regulatory actions form U.S. FDA that could damage image and position of the company. To avoid such undesired circumstances, it is important to see a big picture of TPLC and all applicable U.S. FDA laws and regulation at each phase of their own product life cycle.
Areas Covered in the Session:
An Overview of U.S. FDA Regulation for Medical Devices
Quality System Regulation 21 CFR 820: Current GMP for Medical devices
Premarket Notification - 510(k) and Premarket Approval (PMA)
Post Market Reporting Requirements
FDA Facility Inspection
Who Will Benefit:
Regulatory Affairs - VP, Director and Managers
Regulatory Affairs - Associates and Specialists
Agenda:
Day 1 Schedule
Lecture 1:
Total Product Life Cycle and Your Medical Device
Understand various definitions of Total Product Life Cycle
Importance for define TPLC for your own medical device
Practice Exercise: Define TPLC of your own medical device
Building Regulatory Strategy considering TPLC
Lecture 2:
An Overview of U.S. FDA Medical Device Regulation - Part 1
Lecture 3:
An Overview of U.S. FDA Medical Device Regulation - Part 2
Lecture 4:
Regulations for Design and Product Development
Research & Development
Design Development and Control
Prototype Product Development
Design Verification
Design Validation
Design Transfer to Manufacturing/Production
Helpful Hints and Suggestions
Day 2 Schedule
Lecture 1:
Premarket Notification - 510(k) and Premarket Approval (PMA)
Determine Class of your Medical Device for Regulatory Controls
Exemption form Premarket and QS Regulation requirements
Premarket Notification - 510(k)
Premarket Approval - PMA
Investigational Device Exemption - IDE for clinical studies
Preparation of Premarket Submissions
Helpful Hints and Suggestions
Lecture 2:
Regulations for Production & Process Control - Part 1
Purchasing & Supplier Controls
Document Control
Device Identification and Traceability
Acceptance & Nonconforming Product Control
Labeling & Packaging Control
Helpful Hints and Suggestions
Lecture 3:
Regulations for Production & Process Control - Part 2
Corrective Action and Preventive Action (CAPA)
Records - Device History Record, Device Master Record, QS Record
Complaint Files including Medical device Reporting (MDR)
Post Market Reporting Responsibilities
Helpful Hints and Suggestions
Lecture 4:
Readiness for FDA Facility Inspection
FDA Authority & Practices
FDA Compliance Program Policy, Strategies and Approach
Prepare and Stay Focused during Inspection
Responding to FDA Form 483 Observations
Responding to Warning Letter
Planning and Managing Remediation Project & Activities
Additional Regulatory Actions
Speaker:
Subhash R Patel
Regulatory Affairs & Quality Compliance Consultant, MD Reg Consulting, LLC
Subhash Patel is an accomplished Regulatory Affairs Professional with 30 plus year of experience within U.S. FDA regulated medical device industry. He is considered an authority and subject matter expert (SME) by his clients and colleagues. He offers valuable tips and suggestions "what works and what doesn't" that attendees will interesting and most valuable.
Quick Contact:
NetZealous DBA as GlobalCompliancePanel
Phone: 1-800-447-9407
Fax: 302-288-6884
Email: [email protected]
Website: http://www.globalcompliancepanel.com